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"All", "arm": "Placebo", "measure": "GASTROINTESTINAL DISORDERS", "soc": "GASTROINTESTINAL DISORDERS", "level": "SOC", "n": 17, "events": 26, "denominator": 86, "estimate": 19.767441860465116 }, { "stratum": "All", "arm": "Placebo", "measure": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "SOC", "n": 21, "events": 46, "denominator": 86, "estimate": 24.41860465116279 }, { "stratum": "All", "arm": "Placebo", "measure": "HEPATOBILIARY DISORDERS", "soc": "HEPATOBILIARY DISORDERS", "level": "SOC", "n": 1, "events": 1, "denominator": 86, "estimate": 1.1627906976744187 }, { "stratum": "All", "arm": "Placebo", "measure": "IMMUNE SYSTEM DISORDERS", "soc": "IMMUNE SYSTEM DISORDERS", "level": "SOC", "n": 0, "events": 0, "denominator": 86, "estimate": 0.0 }, { "stratum": "All", "arm": "Placebo", "measure": "INFECTIONS AND INFESTATIONS", "soc": "INFECTIONS AND INFESTATIONS", "level": "SOC", "n": 16, "events": 35, 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"NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)", "soc": "NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)", "level": "SOC", "n": 0, "events": 0, "denominator": 86, "estimate": 0.0 }, { "stratum": "All", "arm": "Placebo", "measure": "NERVOUS SYSTEM DISORDERS", "soc": "NERVOUS SYSTEM DISORDERS", "level": "SOC", "n": 8, "events": 11, "denominator": 86, "estimate": 9.30232558139535 }, { "stratum": "All", "arm": "Placebo", "measure": "PSYCHIATRIC DISORDERS", "soc": "PSYCHIATRIC DISORDERS", "level": "SOC", "n": 10, "events": 12, "denominator": 86, "estimate": 11.627906976744185 }, { "stratum": "All", "arm": "Placebo", "measure": "RENAL AND URINARY DISORDERS", "soc": "RENAL AND URINARY DISORDERS", "level": "SOC", "n": 4, "events": 5, "denominator": 86, "estimate": 4.651162790697675 }, { "stratum": "All", "arm": "Placebo", "measure": "REPRODUCTIVE SYSTEM AND BREAST DISORDERS", "soc": "REPRODUCTIVE SYSTEM AND BREAST DISORDERS", "level": "SOC", "n": 2, 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"events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "SURGICAL AND MEDICAL PROCEDURES", "soc": "SURGICAL AND MEDICAL PROCEDURES", "level": "SOC", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "VASCULAR DISORDERS", "soc": "VASCULAR DISORDERS", "level": "SOC", "n": 3, "events": 3, "denominator": 84, "estimate": 3.5714285714285716 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "ATRIAL FIBRILLATION", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "ATRIAL FLUTTER", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "ATRIAL HYPERTROPHY", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "ATRIOVENTRICULAR BLOCK FIRST DEGREE", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "ATRIOVENTRICULAR BLOCK SECOND DEGREE", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "BRADYCARDIA", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "BUNDLE BRANCH BLOCK LEFT", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "BUNDLE BRANCH BLOCK RIGHT", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "CARDIAC DISORDER", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "CARDIAC FAILURE CONGESTIVE", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "MYOCARDIAL INFARCTION", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 2, "events": 4, "denominator": 84, "estimate": 2.380952380952381 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "PALPITATIONS", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 2, "events": 2, "denominator": 84, "estimate": 2.380952380952381 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "SINUS ARRHYTHMIA", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "SINUS BRADYCARDIA", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 7, "events": 10, "denominator": 84, "estimate": 8.333333333333334 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "SUPRAVENTRICULAR EXTRASYSTOLES", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 1, "events": 2, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "SUPRAVENTRICULAR TACHYCARDIA", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 1, "events": 2, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "TACHYCARDIA", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "VENTRICULAR EXTRASYSTOLES", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 2, "events": 4, "denominator": 84, "estimate": 2.380952380952381 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "VENTRICULAR HYPERTROPHY", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "WOLFF-PARKINSON-WHITE SYNDROME", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 1, "events": 2, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "VENTRICULAR SEPTAL DEFECT", "soc": "CONGENITAL, FAMILIAL AND GENETIC DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "CERUMEN IMPACTION", "soc": "EAR AND LABYRINTH DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "EAR PAIN", "soc": "EAR AND LABYRINTH DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "TINNITUS", "soc": "EAR AND LABYRINTH DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "VERTIGO", "soc": "EAR AND LABYRINTH DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "CONJUNCTIVAL HAEMORRHAGE", "soc": "EYE DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "CONJUNCTIVITIS", "soc": "EYE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "EYE ALLERGY", "soc": "EYE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 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"stratum": "All", "arm": "Xanomeline Low Dose", "measure": "APPLICATION SITE URTICARIA", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 2, "events": 2, "denominator": 84, "estimate": 2.380952380952381 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "APPLICATION SITE VESICLES", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 4, "events": 5, "denominator": 84, "estimate": 4.761904761904762 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "APPLICATION SITE WARMTH", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 1, "events": 2, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "ASTHENIA", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "CHEST 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DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 2, "events": 2, "denominator": 84, "estimate": 2.380952380952381 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "OEDEMA PERIPHERAL", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "PAIN", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 1, "events": 2, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "PYREXIA", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "SECRETION DISCHARGE", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 1, "events": 2, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "SUDDEN DEATH", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "SWELLING", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "ULCER", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "HYPERBILIRUBINAEMIA", "soc": "HEPATOBILIARY DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "HYPERSENSITIVITY", "soc": "IMMUNE SYSTEM DISORDERS", "level": "PT", "n": 1, "events": 2, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "SEASONAL ALLERGY", "soc": "IMMUNE SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "BRONCHITIS", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "CELLULITIS", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "CERVICITIS", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "CYSTITIS", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "EAR INFECTION", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "GASTROENTERITIS VIRAL", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "HORDEOLUM", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "INFLUENZA", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "LOCALISED INFECTION", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "LOWER RESPIRATORY TRACT INFECTION", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "NASOPHARYNGITIS", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 4, "events": 9, "denominator": 84, "estimate": 4.761904761904762 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "ONYCHOMYCOSIS", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "PNEUMONIA", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 1, "events": 2, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "RHINITIS", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "UPPER RESPIRATORY TRACT INFECTION", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 1, "events": 2, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "URINARY TRACT INFECTION", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "VAGINAL MYCOSIS", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "VIRAL INFECTION", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "CONTUSION", "soc": "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "level": "PT", "n": 1, "events": 3, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "EXCORIATION", "soc": "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "level": "PT", "n": 1, "events": 2, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "FACIAL BONES FRACTURE", "soc": "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "FALL", "soc": "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "level": "PT", "n": 2, "events": 2, "denominator": 84, "estimate": 2.380952380952381 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "HIP FRACTURE", "soc": "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "JOINT DISLOCATION", "soc": "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "SKIN LACERATION", "soc": "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "level": "PT", "n": 2, "events": 2, "denominator": 84, "estimate": 2.380952380952381 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "WOUND", "soc": "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "level": "PT", "n": 1, "events": 2, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "BIOPSY", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "BIOPSY PROSTATE", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "BLOOD ALKALINE PHOSPHATASE INCREASED", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "BLOOD CHOLESTEROL INCREASED", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "BLOOD CREATINE PHOSPHOKINASE INCREASED", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "BLOOD GLUCOSE INCREASED", "soc": "INVESTIGATIONS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "BLOOD URINE PRESENT", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "BODY TEMPERATURE INCREASED", "soc": "INVESTIGATIONS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "CYSTOSCOPY", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "ELECTROCARDIOGRAM ST SEGMENT DEPRESSION", "soc": "INVESTIGATIONS", "level": "PT", "n": 1, "events": 2, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED", "soc": "INVESTIGATIONS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "ELECTROCARDIOGRAM T WAVE INVERSION", "soc": "INVESTIGATIONS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "HEART RATE INCREASED", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "HEART RATE IRREGULAR", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "NASAL MUCOSA BIOPSY", "soc": "INVESTIGATIONS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "NEUTROPHIL COUNT INCREASED", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "URINE ANALYSIS ABNORMAL", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "WEIGHT 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AND NUTRITION DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "HYPERCHOLESTEROLAEMIA", "soc": "METABOLISM AND NUTRITION DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "HYPONATRAEMIA", "soc": "METABOLISM AND NUTRITION DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "INCREASED APPETITE", "soc": "METABOLISM AND NUTRITION DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "ARTHRALGIA", "soc": "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "level": "PT", "n": 2, "events": 4, "denominator": 84, "estimate": 2.380952380952381 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "ARTHRITIS", "soc": "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "BACK PAIN", "soc": "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "FLANK PAIN", "soc": "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "MUSCLE SPASMS", "soc": "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "MUSCULAR WEAKNESS", "soc": "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "level": "PT", "n": 1, "events": 2, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "MYALGIA", "soc": "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "PAIN IN EXTREMITY", "soc": "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "SHOULDER PAIN", "soc": "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "level": "PT", "n": 2, "events": 2, "denominator": 84, "estimate": 2.380952380952381 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "COLON CANCER", "soc": "NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "MALIGNANT FIBROUS 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"stratum": "All", "arm": "Xanomeline Low Dose", "measure": "COGNITIVE DISORDER", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "COMPLEX PARTIAL SEIZURES", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "COORDINATION ABNORMAL", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "DIZZINESS", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 8, "events": 13, "denominator": 84, "estimate": 9.523809523809524 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "HEADACHE", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 3, "events": 4, "denominator": 84, "estimate": 3.5714285714285716 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "HEMIANOPIA HOMONYMOUS", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "HYPERSOMNIA", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "LETHARGY", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "PARAESTHESIA", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "PARAESTHESIA ORAL", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "PARKINSON'S DISEASE", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "PAROSMIA", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "PARTIAL SEIZURES WITH SECONDARY GENERALISATION", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "PSYCHOMOTOR HYPERACTIVITY", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "SOMNOLENCE", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 3, "events": 5, "denominator": 84, "estimate": 3.5714285714285716 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "STUPOR", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "SYNCOPE", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 4, "events": 6, "denominator": 84, "estimate": 4.761904761904762 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "SYNCOPE VASOVAGAL", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "TRANSIENT ISCHAEMIC ATTACK", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 2, "events": 3, "denominator": 84, "estimate": 2.380952380952381 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "AGITATION", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 2, "events": 2, "denominator": 84, "estimate": 2.380952380952381 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "ANXIETY", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 3, "events": 4, "denominator": 84, "estimate": 3.5714285714285716 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "COMPLETED SUICIDE", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "CONFUSIONAL STATE", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 3, "events": 3, "denominator": 84, "estimate": 3.5714285714285716 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "DELIRIUM", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "DELUSION", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "DEPRESSED MOOD", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 1, "events": 2, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "DISORIENTATION", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "HALLUCINATION", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "HALLUCINATION, VISUAL", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "INSOMNIA", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "IRRITABILITY", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "LIBIDO DECREASED", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "LISTLESS", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "NIGHTMARE", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "RESTLESSNESS", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 1, "events": 2, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "CALCULUS URETHRAL", "soc": "RENAL AND URINARY DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "DYSURIA", "soc": "RENAL AND URINARY DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "ENURESIS", "soc": "RENAL AND URINARY DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "INCONTINENCE", "soc": "RENAL AND URINARY DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "MICTURITION URGENCY", "soc": "RENAL AND URINARY DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "NEPHROLITHIASIS", "soc": "RENAL AND URINARY DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "POLLAKIURIA", "soc": "RENAL AND URINARY DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "BENIGN PROSTATIC HYPERPLASIA", "soc": "REPRODUCTIVE SYSTEM AND BREAST DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "PELVIC PAIN", "soc": "REPRODUCTIVE SYSTEM AND BREAST DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "ALLERGIC GRANULOMATOUS ANGIITIS", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "COUGH", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 5, "events": 7, "denominator": 84, "estimate": 5.9523809523809526 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "DYSPHONIA", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "DYSPNOEA", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "EMPHYSEMA", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "EPISTAXIS", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "HAEMOPTYSIS", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "NASAL CONGESTION", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "PHARYNGEAL ERYTHEMA", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "PHARYNGOLARYNGEAL PAIN", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "POSTNASAL DRIP", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "PRODUCTIVE COUGH", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "RALES", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "RESPIRATORY TRACT CONGESTION", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "RHINORRHOEA", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 1, "events": 2, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "ACTINIC KERATOSIS", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "ALOPECIA", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "BLISTER", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 5, "events": 8, "denominator": 84, "estimate": 5.9523809523809526 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "COLD SWEAT", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "DERMATITIS ATOPIC", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low 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25.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "PRURITUS GENERALISED", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 1, "events": 4, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "RASH", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 13, "events": 18, "denominator": 84, "estimate": 15.476190476190476 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "RASH ERYTHEMATOUS", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "RASH MACULO-PAPULAR", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "RASH PAPULAR", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "RASH PRURITIC", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 1, "events": 2, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "SKIN EXFOLIATION", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 1, "events": 2, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "SKIN IRRITATION", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 6, "events": 13, "denominator": 84, "estimate": 7.142857142857143 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "SKIN ODOUR ABNORMAL", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "SKIN 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"EYE LASER SURGERY", "soc": "SURGICAL AND MEDICAL PROCEDURES", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "SKIN LESION EXCISION", "soc": "SURGICAL AND MEDICAL PROCEDURES", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "HOT FLUSH", "soc": "VASCULAR DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "HYPERTENSION", "soc": "VASCULAR DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "HYPOTENSION", "soc": "VASCULAR DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "ORTHOSTATIC HYPOTENSION", "soc": "VASCULAR DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline Low Dose", "measure": "WOUND HAEMORRHAGE", "soc": "VASCULAR DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "Any treatment-emergent AE", "soc": "", "level": "Any", "n": 76, "events": 433, "denominator": 84, "estimate": 90.47619047619048 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "CARDIAC DISORDERS", "soc": "CARDIAC DISORDERS", "level": "SOC", "n": 15, "events": 30, "denominator": 84, "estimate": 17.857142857142858 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "CONGENITAL, FAMILIAL AND GENETIC DISORDERS", "soc": "CONGENITAL, FAMILIAL AND GENETIC DISORDERS", "level": "SOC", "n": 2, "events": 2, "denominator": 84, "estimate": 2.380952380952381 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "EAR AND LABYRINTH DISORDERS", "soc": "EAR AND LABYRINTH DISORDERS", "level": "SOC", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "EYE DISORDERS", "soc": "EYE DISORDERS", "level": "SOC", "n": 1, "events": 2, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "GASTROINTESTINAL DISORDERS", "soc": "GASTROINTESTINAL DISORDERS", "level": "SOC", "n": 20, "events": 36, "denominator": 84, "estimate": 23.80952380952381 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "SOC", "n": 40, "events": 124, "denominator": 84, "estimate": 47.61904761904762 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "HEPATOBILIARY DISORDERS", "soc": "HEPATOBILIARY DISORDERS", "level": "SOC", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "IMMUNE SYSTEM DISORDERS", "soc": "IMMUNE SYSTEM DISORDERS", "level": "SOC", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "INFECTIONS AND INFESTATIONS", "soc": "INFECTIONS AND INFESTATIONS", "level": "SOC", "n": 13, "events": 20, "denominator": 84, "estimate": 15.476190476190476 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "soc": "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "level": "SOC", "n": 5, "events": 8, "denominator": 84, "estimate": 5.9523809523809526 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "INVESTIGATIONS", "soc": "INVESTIGATIONS", "level": "SOC", "n": 6, "events": 8, "denominator": 84, "estimate": 7.142857142857143 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "METABOLISM AND NUTRITION DISORDERS", "soc": "METABOLISM AND NUTRITION DISORDERS", "level": "SOC", "n": 2, "events": 4, "denominator": 84, "estimate": 2.380952380952381 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "soc": "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "level": "SOC", "n": 7, "events": 10, "denominator": 84, "estimate": 8.333333333333334 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)", "soc": "NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)", "level": "SOC", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "NERVOUS SYSTEM DISORDERS", "soc": "NERVOUS SYSTEM DISORDERS", "level": "SOC", "n": 25, "events": 41, "denominator": 84, "estimate": 29.761904761904763 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "PSYCHIATRIC DISORDERS", "soc": "PSYCHIATRIC DISORDERS", "level": "SOC", "n": 8, "events": 11, "denominator": 84, "estimate": 9.523809523809524 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "RENAL AND URINARY DISORDERS", "soc": "RENAL AND URINARY DISORDERS", "level": "SOC", "n": 3, "events": 4, "denominator": 84, "estimate": 3.5714285714285716 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "REPRODUCTIVE SYSTEM AND BREAST DISORDERS", "soc": "REPRODUCTIVE SYSTEM AND BREAST DISORDERS", "level": "SOC", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "SOC", "n": 10, "events": 22, "denominator": 84, "estimate": 11.904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "SOC", "n": 40, "events": 104, "denominator": 84, "estimate": 47.61904761904762 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "SOCIAL CIRCUMSTANCES", "soc": "SOCIAL CIRCUMSTANCES", "level": "SOC", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "SURGICAL AND MEDICAL PROCEDURES", "soc": "SURGICAL AND MEDICAL PROCEDURES", "level": "SOC", "n": 2, "events": 2, "denominator": 84, "estimate": 2.380952380952381 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "VASCULAR DISORDERS", "soc": "VASCULAR DISORDERS", "level": "SOC", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "ATRIAL FIBRILLATION", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 3, "events": 5, "denominator": 84, "estimate": 3.5714285714285716 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "ATRIAL FLUTTER", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 1, "events": 2, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "ATRIAL HYPERTROPHY", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "ATRIOVENTRICULAR BLOCK FIRST DEGREE", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "ATRIOVENTRICULAR BLOCK SECOND DEGREE", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "BRADYCARDIA", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "BUNDLE BRANCH BLOCK LEFT", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "BUNDLE BRANCH BLOCK RIGHT", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "CARDIAC DISORDER", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "CARDIAC FAILURE CONGESTIVE", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "MYOCARDIAL INFARCTION", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 4, "events": 8, "denominator": 84, "estimate": 4.761904761904762 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "PALPITATIONS", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "SINUS ARRHYTHMIA", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "SINUS BRADYCARDIA", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 8, "events": 12, "denominator": 84, "estimate": 9.523809523809524 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "SUPRAVENTRICULAR EXTRASYSTOLES", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "SUPRAVENTRICULAR TACHYCARDIA", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "TACHYCARDIA", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "VENTRICULAR EXTRASYSTOLES", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "VENTRICULAR HYPERTROPHY", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "WOLFF-PARKINSON-WHITE SYNDROME", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "VENTRICULAR SEPTAL DEFECT", "soc": "CONGENITAL, FAMILIAL AND GENETIC DISORDERS", "level": "PT", "n": 2, "events": 2, "denominator": 84, "estimate": 2.380952380952381 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "CERUMEN 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"PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "EYE ALLERGY", "soc": "EYE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "EYE PRURITUS", "soc": "EYE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "EYE SWELLING", "soc": "EYE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "GLAUCOMA", "soc": "EYE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "VISION BLURRED", "soc": "EYE DISORDERS", "level": "PT", "n": 1, "events": 2, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High 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"measure": "DYSPHAGIA", "soc": "GASTROINTESTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "FLATULENCE", "soc": "GASTROINTESTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "GASTROINTESTINAL HAEMORRHAGE", "soc": "GASTROINTESTINAL DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "GASTROOESOPHAGEAL REFLUX DISEASE", "soc": "GASTROINTESTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "GLOSSITIS", "soc": "GASTROINTESTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "HIATUS HERNIA", "soc": "GASTROINTESTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "NAUSEA", "soc": "GASTROINTESTINAL DISORDERS", "level": "PT", "n": 6, "events": 13, "denominator": 84, "estimate": 7.142857142857143 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "RECTAL HAEMORRHAGE", "soc": "GASTROINTESTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "SALIVARY HYPERSECRETION", "soc": "GASTROINTESTINAL DISORDERS", "level": "PT", "n": 4, "events": 5, "denominator": 84, "estimate": 4.761904761904762 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "STOMACH DISCOMFORT", "soc": "GASTROINTESTINAL DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "VOMITING", "soc": "GASTROINTESTINAL DISORDERS", "level": "PT", "n": 7, "events": 9, "denominator": 84, "estimate": 8.333333333333334 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "APPLICATION SITE BLEEDING", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "APPLICATION SITE DERMATITIS", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 7, "events": 12, "denominator": 84, "estimate": 8.333333333333334 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "APPLICATION SITE DESQUAMATION", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "APPLICATION SITE DISCHARGE", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "APPLICATION SITE DISCOLOURATION", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "APPLICATION SITE ERYTHEMA", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 15, "events": 23, "denominator": 84, "estimate": 17.857142857142858 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "APPLICATION SITE INDURATION", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "APPLICATION SITE IRRITATION", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 9, "events": 16, "denominator": 84, "estimate": 10.714285714285714 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "APPLICATION SITE PAIN", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 2, "events": 2, "denominator": 84, "estimate": 2.380952380952381 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "APPLICATION SITE PERSPIRATION", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 2, "events": 3, "denominator": 84, "estimate": 2.380952380952381 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "APPLICATION SITE PRURITUS", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 22, "events": 35, "denominator": 84, "estimate": 26.19047619047619 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "APPLICATION SITE REACTION", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "APPLICATION SITE SWELLING", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 2, "events": 3, "denominator": 84, "estimate": 2.380952380952381 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "APPLICATION SITE URTICARIA", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "APPLICATION SITE VESICLES", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 6, "events": 6, "denominator": 84, "estimate": 7.142857142857143 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "APPLICATION SITE WARMTH", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "ASTHENIA", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "CHEST DISCOMFORT", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 2, "events": 2, "denominator": 84, "estimate": 2.380952380952381 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "CHEST PAIN", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 2, "events": 2, "denominator": 84, "estimate": 2.380952380952381 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "CHILLS", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "CYST", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "FATIGUE", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 5, "events": 5, "denominator": 84, "estimate": 5.9523809523809526 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "FEELING ABNORMAL", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "FEELING COLD", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "INFLAMMATION", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "MALAISE", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 2, "events": 3, "denominator": 84, "estimate": 2.380952380952381 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "OEDEMA", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "OEDEMA PERIPHERAL", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 2, "events": 3, "denominator": 84, "estimate": 2.380952380952381 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "PAIN", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "PYREXIA", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "SECRETION DISCHARGE", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "SUDDEN DEATH", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "SWELLING", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "ULCER", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "HYPERBILIRUBINAEMIA", "soc": "HEPATOBILIARY DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "HYPERSENSITIVITY", "soc": "IMMUNE SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "SEASONAL ALLERGY", "soc": "IMMUNE SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "BRONCHITIS", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "CELLULITIS", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "CERVICITIS", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "CYSTITIS", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "EAR INFECTION", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "GASTROENTERITIS VIRAL", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "HORDEOLUM", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "INFLUENZA", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "LOCALISED INFECTION", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "LOWER RESPIRATORY TRACT INFECTION", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 1, "events": 2, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "NASOPHARYNGITIS", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 6, "events": 8, "denominator": 84, "estimate": 7.142857142857143 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "ONYCHOMYCOSIS", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline 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"All", "arm": "Xanomeline High Dose", "measure": "VIRAL INFECTION", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "CONTUSION", "soc": "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "level": "PT", "n": 2, "events": 3, "denominator": 84, "estimate": 2.380952380952381 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "EXCORIATION", "soc": "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "FACIAL BONES FRACTURE", "soc": "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "FALL", "soc": "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "HIP FRACTURE", "soc": "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "level": "PT", "n": 2, "events": 2, "denominator": 84, "estimate": 2.380952380952381 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "JOINT DISLOCATION", "soc": "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "SKIN LACERATION", "soc": "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "WOUND", "soc": "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "BIOPSY", "soc": "INVESTIGATIONS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "BIOPSY PROSTATE", "soc": "INVESTIGATIONS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "BLOOD ALKALINE PHOSPHATASE INCREASED", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "BLOOD CHOLESTEROL INCREASED", "soc": "INVESTIGATIONS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "BLOOD CREATINE PHOSPHOKINASE INCREASED", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "BLOOD GLUCOSE 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"INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "ELECTROCARDIOGRAM T WAVE INVERSION", "soc": "INVESTIGATIONS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "HEART RATE INCREASED", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "HEART RATE IRREGULAR", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "NASAL MUCOSA BIOPSY", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "NEUTROPHIL COUNT INCREASED", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, 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"Xanomeline High Dose", "measure": "MUSCLE SPASMS", "soc": "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "level": "PT", "n": 1, "events": 2, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "MUSCULAR WEAKNESS", "soc": "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "MYALGIA", "soc": "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "PAIN IN EXTREMITY", "soc": "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "SHOULDER PAIN", "soc": "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "COLON CANCER", "soc": "NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "MALIGNANT FIBROUS HISTIOCYTOMA", "soc": "NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "PROSTATE CANCER", "soc": "NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "AMNESIA", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 1, "events": 2, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "BALANCE DISORDER", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "BURNING SENSATION", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 2, "events": 2, "denominator": 84, "estimate": 2.380952380952381 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "COGNITIVE DISORDER", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "COMPLEX PARTIAL SEIZURES", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "COORDINATION ABNORMAL", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "DIZZINESS", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 11, "events": 15, "denominator": 84, "estimate": 13.095238095238095 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "HEADACHE", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 5, "events": 8, "denominator": 84, "estimate": 5.9523809523809526 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "HEMIANOPIA HOMONYMOUS", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "HYPERSOMNIA", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "LETHARGY", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "PARAESTHESIA", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "PARAESTHESIA ORAL", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "PARKINSON'S DISEASE", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "PAROSMIA", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 1, "events": 2, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "PARTIAL SEIZURES WITH SECONDARY GENERALISATION", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "PSYCHOMOTOR HYPERACTIVITY", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "SOMNOLENCE", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "STUPOR", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "SYNCOPE", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 3, "events": 4, "denominator": 84, "estimate": 3.5714285714285716 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "SYNCOPE VASOVAGAL", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "TRANSIENT ISCHAEMIC ATTACK", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "AGITATION", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "ANXIETY", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "COMPLETED SUICIDE", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "CONFUSIONAL STATE", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "DELIRIUM", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "DELUSION", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "DEPRESSED MOOD", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "DISORIENTATION", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "HALLUCINATION", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "HALLUCINATION, VISUAL", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "INSOMNIA", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 2, "events": 2, "denominator": 84, "estimate": 2.380952380952381 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "IRRITABILITY", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "LIBIDO DECREASED", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "LISTLESS", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "NIGHTMARE", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "RESTLESSNESS", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "CALCULUS URETHRAL", "soc": "RENAL AND URINARY DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "DYSURIA", "soc": "RENAL AND URINARY DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "ENURESIS", "soc": "RENAL AND URINARY DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "INCONTINENCE", "soc": "RENAL AND URINARY DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "MICTURITION URGENCY", "soc": "RENAL AND URINARY DISORDERS", "level": "PT", "n": 1, "events": 2, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "NEPHROLITHIASIS", "soc": "RENAL AND URINARY DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "POLLAKIURIA", "soc": "RENAL AND URINARY DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "BENIGN PROSTATIC HYPERPLASIA", "soc": "REPRODUCTIVE SYSTEM AND BREAST DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "PELVIC PAIN", "soc": "REPRODUCTIVE SYSTEM AND BREAST DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "ALLERGIC GRANULOMATOUS ANGIITIS", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "COUGH", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 5, "events": 7, "denominator": 84, "estimate": 5.9523809523809526 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "DYSPHONIA", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "DYSPNOEA", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "EMPHYSEMA", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "EPISTAXIS", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 2, "events": 2, "denominator": 84, "estimate": 2.380952380952381 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "HAEMOPTYSIS", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "NASAL CONGESTION", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 3, "events": 4, "denominator": 84, "estimate": 3.5714285714285716 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "PHARYNGEAL ERYTHEMA", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 1, "events": 2, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "PHARYNGOLARYNGEAL PAIN", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "POSTNASAL DRIP", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "PRODUCTIVE COUGH", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "RALES", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "RESPIRATORY TRACT CONGESTION", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "RHINORRHOEA", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 1, "events": 2, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "ACTINIC KERATOSIS", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "ALOPECIA", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "BLISTER", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 1, "events": 2, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "COLD SWEAT", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "DERMATITIS ATOPIC", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "DERMATITIS CONTACT", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "DRUG ERUPTION", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "ERYTHEMA", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 14, "events": 22, "denominator": 84, "estimate": 16.666666666666668 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "HYPERHIDROSIS", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 8, "events": 10, "denominator": 84, "estimate": 9.523809523809524 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "PRURITUS", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 26, "events": 38, "denominator": 84, "estimate": 30.952380952380953 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "PRURITUS GENERALISED", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "RASH", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 9, "events": 15, "denominator": 84, "estimate": 10.714285714285714 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "RASH ERYTHEMATOUS", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "RASH MACULO-PAPULAR", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "RASH PAPULAR", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "RASH PRURITIC", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 2, "events": 3, "denominator": 84, "estimate": 2.380952380952381 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "SKIN EXFOLIATION", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "SKIN IRRITATION", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 5, "events": 8, "denominator": 84, "estimate": 5.9523809523809526 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "SKIN ODOUR ABNORMAL", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "SKIN ULCER", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "URTICARIA", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 1, "events": 2, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "ALCOHOL USE", "soc": "SOCIAL CIRCUMSTANCES", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "ACROCHORDON EXCISION", "soc": "SURGICAL AND MEDICAL PROCEDURES", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "CATARACT OPERATION", "soc": "SURGICAL AND MEDICAL PROCEDURES", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "EYE LASER SURGERY", "soc": "SURGICAL AND MEDICAL PROCEDURES", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "SKIN LESION EXCISION", "soc": "SURGICAL AND MEDICAL PROCEDURES", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "HOT FLUSH", "soc": "VASCULAR DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "HYPERTENSION", "soc": "VASCULAR DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "HYPOTENSION", "soc": "VASCULAR DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "ORTHOSTATIC HYPOTENSION", "soc": "VASCULAR DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 84, "estimate": 0.0 }, { "stratum": "All", "arm": "Xanomeline High Dose", "measure": "WOUND HAEMORRHAGE", "soc": "VASCULAR DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 84, "estimate": 1.1904761904761905 }, { "stratum": "F", "arm": "Placebo", "measure": "Any treatment-emergent AE", "soc": "", "level": "Any", "n": 40, "events": 161, "denominator": 53, "estimate": 75.47169811320755 }, { "stratum": "F", "arm": "Placebo", "measure": "CARDIAC DISORDERS", "soc": "CARDIAC DISORDERS", "level": "SOC", "n": 9, "events": 21, "denominator": 53, "estimate": 16.9811320754717 }, { "stratum": "F", "arm": "Placebo", "measure": "CONGENITAL, FAMILIAL AND GENETIC DISORDERS", "soc": "CONGENITAL, FAMILIAL AND GENETIC DISORDERS", "level": "SOC", "n": 0, "events": 0, "denominator": 53, "estimate": 0.0 }, { "stratum": "F", "arm": "Placebo", "measure": "EAR AND LABYRINTH DISORDERS", "soc": "EAR AND LABYRINTH DISORDERS", "level": "SOC", "n": 1, "events": 2, "denominator": 53, "estimate": 1.8867924528301887 }, { "stratum": "F", "arm": "Placebo", "measure": "EYE DISORDERS", "soc": "EYE DISORDERS", "level": "SOC", "n": 0, "events": 0, "denominator": 53, "estimate": 0.0 }, { "stratum": "F", "arm": "Placebo", "measure": "GASTROINTESTINAL DISORDERS", "soc": "GASTROINTESTINAL DISORDERS", "level": "SOC", "n": 9, "events": 15, "denominator": 53, "estimate": 16.9811320754717 }, { "stratum": "F", "arm": "Placebo", "measure": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "SOC", "n": 12, "events": 24, "denominator": 53, "estimate": 22.641509433962263 }, { "stratum": "F", "arm": "Placebo", "measure": "HEPATOBILIARY DISORDERS", "soc": "HEPATOBILIARY DISORDERS", "level": "SOC", "n": 1, "events": 1, "denominator": 53, "estimate": 1.8867924528301887 }, { "stratum": "F", "arm": "Placebo", "measure": "IMMUNE SYSTEM DISORDERS", "soc": "IMMUNE SYSTEM DISORDERS", "level": "SOC", "n": 0, "events": 0, "denominator": 53, "estimate": 0.0 }, { "stratum": "F", "arm": "Placebo", "measure": "INFECTIONS AND INFESTATIONS", "soc": "INFECTIONS AND INFESTATIONS", "level": "SOC", "n": 10, "events": 22, "denominator": 53, "estimate": 18.867924528301888 }, { "stratum": "F", "arm": "Placebo", "measure": "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "soc": "INJURY, 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"F", "arm": "Placebo", "measure": "RESTLESSNESS", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 53, "estimate": 0.0 }, { "stratum": "F", "arm": "Placebo", "measure": "CALCULUS URETHRAL", "soc": "RENAL AND URINARY DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 53, "estimate": 0.0 }, { "stratum": "F", "arm": "Placebo", "measure": "DYSURIA", "soc": "RENAL AND URINARY DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 53, "estimate": 1.8867924528301887 }, { "stratum": "F", "arm": "Placebo", "measure": "ENURESIS", "soc": "RENAL AND URINARY DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 53, "estimate": 0.0 }, { "stratum": "F", "arm": "Placebo", "measure": "INCONTINENCE", "soc": "RENAL AND URINARY DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 53, "estimate": 0.0 }, { "stratum": "F", "arm": "Placebo", "measure": "MICTURITION URGENCY", "soc": "RENAL AND URINARY DISORDERS", "level": "PT", "n": 0, 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"level": "SOC", "n": 9, "events": 18, "denominator": 50, "estimate": 18.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "PSYCHIATRIC DISORDERS", "soc": "PSYCHIATRIC DISORDERS", "level": "SOC", "n": 7, "events": 9, "denominator": 50, "estimate": 14.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "RENAL AND URINARY DISORDERS", "soc": "RENAL AND URINARY DISORDERS", "level": "SOC", "n": 2, "events": 2, "denominator": 50, "estimate": 4.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "REPRODUCTIVE SYSTEM AND BREAST DISORDERS", "soc": "REPRODUCTIVE SYSTEM AND BREAST DISORDERS", "level": "SOC", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "SOC", "n": 5, "events": 8, "denominator": 50, "estimate": 10.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "SOC", "n": 21, "events": 65, "denominator": 50, "estimate": 42.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "SOCIAL CIRCUMSTANCES", "soc": "SOCIAL CIRCUMSTANCES", "level": "SOC", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "SURGICAL AND MEDICAL PROCEDURES", "soc": "SURGICAL AND MEDICAL PROCEDURES", "level": "SOC", "n": 1, "events": 1, "denominator": 50, "estimate": 2.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "VASCULAR DISORDERS", "soc": "VASCULAR DISORDERS", "level": "SOC", "n": 2, "events": 2, "denominator": 50, "estimate": 4.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "ATRIAL FIBRILLATION", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "ATRIAL FLUTTER", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "ATRIAL HYPERTROPHY", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "ATRIOVENTRICULAR BLOCK FIRST DEGREE", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "ATRIOVENTRICULAR BLOCK SECOND DEGREE", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "BRADYCARDIA", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "BUNDLE BRANCH BLOCK LEFT", "soc": "CARDIAC 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"estimate": 2.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "SINUS ARRHYTHMIA", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "SINUS BRADYCARDIA", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 3, "events": 5, "denominator": 50, "estimate": 6.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "SUPRAVENTRICULAR EXTRASYSTOLES", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 1, "events": 2, "denominator": 50, "estimate": 2.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "SUPRAVENTRICULAR TACHYCARDIA", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "TACHYCARDIA", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "VENTRICULAR EXTRASYSTOLES", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 1, "events": 2, "denominator": 50, "estimate": 2.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "VENTRICULAR HYPERTROPHY", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "WOLFF-PARKINSON-WHITE SYNDROME", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 1, "events": 2, "denominator": 50, "estimate": 2.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "VENTRICULAR SEPTAL DEFECT", "soc": "CONGENITAL, FAMILIAL AND GENETIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "CERUMEN IMPACTION", "soc": "EAR AND LABYRINTH DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 50, "estimate": 2.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "EAR 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"GASTROINTESTINAL DISORDERS", "level": "PT", "n": 2, "events": 2, "denominator": 50, "estimate": 4.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "CONSTIPATION", "soc": "GASTROINTESTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "DIARRHOEA", "soc": "GASTROINTESTINAL DISORDERS", "level": "PT", "n": 2, "events": 2, "denominator": 50, "estimate": 4.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "DYSPEPSIA", "soc": "GASTROINTESTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "DYSPHAGIA", "soc": "GASTROINTESTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "FLATULENCE", "soc": "GASTROINTESTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 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"arm": "Xanomeline Low Dose", "measure": "RECTAL HAEMORRHAGE", "soc": "GASTROINTESTINAL DISORDERS", "level": "PT", "n": 1, "events": 2, "denominator": 50, "estimate": 2.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "SALIVARY HYPERSECRETION", "soc": "GASTROINTESTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "STOMACH DISCOMFORT", "soc": "GASTROINTESTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "VOMITING", "soc": "GASTROINTESTINAL DISORDERS", "level": "PT", "n": 3, "events": 4, "denominator": 50, "estimate": 6.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "APPLICATION SITE BLEEDING", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 1, "events": 1, "denominator": 50, "estimate": 2.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "APPLICATION SITE DERMATITIS", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 5, "events": 8, "denominator": 50, "estimate": 10.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "APPLICATION SITE DESQUAMATION", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "APPLICATION SITE DISCHARGE", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "APPLICATION SITE DISCOLOURATION", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "APPLICATION SITE ERYTHEMA", "soc": "GENERAL 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"Xanomeline Low Dose", "measure": "ULCER", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "HYPERBILIRUBINAEMIA", "soc": "HEPATOBILIARY DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "HYPERSENSITIVITY", "soc": "IMMUNE SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "SEASONAL ALLERGY", "soc": "IMMUNE SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "BRONCHITIS", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "CELLULITIS", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 1, "events": 1, "denominator": 50, "estimate": 2.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "CERVICITIS", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "CYSTITIS", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "EAR INFECTION", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "GASTROENTERITIS VIRAL", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "HORDEOLUM", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "INFLUENZA", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "LOCALISED INFECTION", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "LOWER RESPIRATORY TRACT INFECTION", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "NASOPHARYNGITIS", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 3, "events": 7, "denominator": 50, "estimate": 6.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "ONYCHOMYCOSIS", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "PNEUMONIA", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 1, "events": 2, "denominator": 50, "estimate": 2.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "RHINITIS", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "UPPER RESPIRATORY TRACT INFECTION", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "URINARY TRACT INFECTION", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "VAGINAL MYCOSIS", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "VIRAL INFECTION", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 1, "events": 1, "denominator": 50, "estimate": 2.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "CONTUSION", "soc": "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "level": "PT", "n": 1, "events": 3, "denominator": 50, "estimate": 2.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "EXCORIATION", "soc": "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "level": "PT", "n": 1, "events": 2, "denominator": 50, "estimate": 2.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "FACIAL BONES FRACTURE", "soc": "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "FALL", "soc": "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "level": "PT", "n": 2, "events": 2, "denominator": 50, "estimate": 4.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "HIP FRACTURE", "soc": "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "JOINT DISLOCATION", "soc": "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "level": "PT", "n": 1, "events": 1, "denominator": 50, "estimate": 2.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "SKIN LACERATION", "soc": "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "level": "PT", "n": 2, "events": 2, "denominator": 50, "estimate": 4.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "WOUND", "soc": "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "level": "PT", "n": 1, "events": 2, "denominator": 50, "estimate": 2.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "BIOPSY", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "BIOPSY PROSTATE", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "BLOOD ALKALINE PHOSPHATASE INCREASED", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "BLOOD CHOLESTEROL INCREASED", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "BLOOD CREATINE PHOSPHOKINASE INCREASED", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "BLOOD GLUCOSE INCREASED", "soc": "INVESTIGATIONS", "level": "PT", "n": 1, "events": 1, "denominator": 50, "estimate": 2.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "BLOOD URINE PRESENT", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "BODY TEMPERATURE INCREASED", "soc": "INVESTIGATIONS", "level": "PT", "n": 1, "events": 1, "denominator": 50, "estimate": 2.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "CYSTOSCOPY", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "ELECTROCARDIOGRAM ST SEGMENT DEPRESSION", "soc": "INVESTIGATIONS", "level": "PT", "n": 1, "events": 2, "denominator": 50, "estimate": 2.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "ELECTROCARDIOGRAM T WAVE INVERSION", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "HEART RATE INCREASED", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "HEART RATE IRREGULAR", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "NASAL MUCOSA BIOPSY", "soc": "INVESTIGATIONS", "level": "PT", "n": 1, "events": 1, "denominator": 50, "estimate": 2.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "NEUTROPHIL COUNT INCREASED", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "URINE ANALYSIS ABNORMAL", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "WEIGHT DECREASED", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "WHITE BLOOD CELL COUNT INCREASED", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "DECREASED APPETITE", "soc": "METABOLISM AND NUTRITION DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "DEHYDRATION", "soc": "METABOLISM AND NUTRITION DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "DIABETES MELLITUS", "soc": "METABOLISM AND NUTRITION DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "FOOD CRAVING", "soc": "METABOLISM AND NUTRITION DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "HYPERCHOLESTEROLAEMIA", "soc": "METABOLISM AND NUTRITION DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "HYPONATRAEMIA", "soc": "METABOLISM AND NUTRITION DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "INCREASED APPETITE", "soc": "METABOLISM AND NUTRITION DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "ARTHRALGIA", "soc": "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 50, "estimate": 2.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "ARTHRITIS", "soc": "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "BACK PAIN", "soc": "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 50, "estimate": 2.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "FLANK PAIN", "soc": "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "MUSCLE SPASMS", "soc": "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "MUSCULAR WEAKNESS", "soc": "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "level": "PT", "n": 1, "events": 2, "denominator": 50, "estimate": 2.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "MYALGIA", "soc": "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "PAIN IN EXTREMITY", "soc": "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "SHOULDER PAIN", "soc": "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "level": "PT", "n": 2, "events": 2, "denominator": 50, "estimate": 4.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "COLON CANCER", "soc": "NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)", "level": "PT", "n": 1, "events": 1, "denominator": 50, "estimate": 2.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "MALIGNANT FIBROUS HISTIOCYTOMA", "soc": "NEOPLASMS 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"soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "COMPLEX PARTIAL SEIZURES", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 50, "estimate": 2.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "COORDINATION ABNORMAL", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 50, "estimate": 2.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "DIZZINESS", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 4, "events": 6, "denominator": 50, "estimate": 8.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "HEADACHE", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "HEMIANOPIA HOMONYMOUS", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "HYPERSOMNIA", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "LETHARGY", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "PARAESTHESIA", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "PARAESTHESIA ORAL", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 50, "estimate": 2.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "PARKINSON'S DISEASE", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "PAROSMIA", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "PARTIAL SEIZURES WITH SECONDARY GENERALISATION", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "PSYCHOMOTOR HYPERACTIVITY", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "SOMNOLENCE", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "STUPOR", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "SYNCOPE", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 4, "events": 6, "denominator": 50, "estimate": 8.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "SYNCOPE VASOVAGAL", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "TRANSIENT ISCHAEMIC ATTACK", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "AGITATION", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 2, "events": 2, "denominator": 50, "estimate": 4.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "ANXIETY", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 3, "events": 4, "denominator": 50, "estimate": 6.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "COMPLETED SUICIDE", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "CONFUSIONAL STATE", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 2, "events": 2, "denominator": 50, "estimate": 4.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "DELIRIUM", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "DELUSION", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "DEPRESSED MOOD", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "DISORIENTATION", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "HALLUCINATION", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "HALLUCINATION, VISUAL", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "INSOMNIA", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "IRRITABILITY", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 50, "estimate": 2.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "LIBIDO DECREASED", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "LISTLESS", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "NIGHTMARE", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "RESTLESSNESS", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "CALCULUS URETHRAL", "soc": "RENAL AND URINARY DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "DYSURIA", "soc": "RENAL AND URINARY DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "ENURESIS", "soc": "RENAL AND URINARY DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "INCONTINENCE", "soc": "RENAL AND URINARY DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 50, "estimate": 2.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "MICTURITION URGENCY", "soc": "RENAL AND URINARY DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 50, "estimate": 2.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "NEPHROLITHIASIS", "soc": "RENAL AND URINARY DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "POLLAKIURIA", "soc": "RENAL AND URINARY DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "BENIGN PROSTATIC HYPERPLASIA", "soc": "REPRODUCTIVE SYSTEM AND BREAST DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "PELVIC PAIN", "soc": "REPRODUCTIVE SYSTEM AND BREAST DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "ALLERGIC GRANULOMATOUS ANGIITIS", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "COUGH", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 3, "events": 4, "denominator": 50, "estimate": 6.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "DYSPHONIA", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "DYSPNOEA", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 50, "estimate": 2.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "EMPHYSEMA", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "EPISTAXIS", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 50, "estimate": 2.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "HAEMOPTYSIS", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "NASAL CONGESTION", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "PHARYNGEAL ERYTHEMA", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "PHARYNGOLARYNGEAL PAIN", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "POSTNASAL DRIP", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "PRODUCTIVE COUGH", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "RALES", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "RESPIRATORY TRACT CONGESTION", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "RHINORRHOEA", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 1, "events": 2, "denominator": 50, "estimate": 2.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "ACTINIC KERATOSIS", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "ALOPECIA", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "BLISTER", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 2, "events": 3, "denominator": 50, "estimate": 4.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "COLD SWEAT", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "DERMATITIS ATOPIC", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "DERMATITIS CONTACT", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "DRUG ERUPTION", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "ERYTHEMA", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 8, "events": 14, "denominator": 50, "estimate": 16.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "HYPERHIDROSIS", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 50, "estimate": 2.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "PRURITUS", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 11, "events": 19, "denominator": 50, "estimate": 22.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "PRURITUS GENERALISED", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "RASH", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 8, "events": 13, "denominator": 50, "estimate": 16.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "RASH ERYTHEMATOUS", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "RASH MACULO-PAPULAR", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "RASH PAPULAR", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "RASH PRURITIC", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 1, "events": 2, "denominator": 50, "estimate": 2.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "SKIN EXFOLIATION", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 1, "events": 2, "denominator": 50, "estimate": 2.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "SKIN IRRITATION", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 5, "events": 11, "denominator": 50, "estimate": 10.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "SKIN ODOUR ABNORMAL", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "SKIN ULCER", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "URTICARIA", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "ALCOHOL USE", "soc": "SOCIAL CIRCUMSTANCES", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "ACROCHORDON EXCISION", "soc": "SURGICAL AND MEDICAL PROCEDURES", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "CATARACT OPERATION", "soc": "SURGICAL AND MEDICAL PROCEDURES", "level": "PT", "n": 1, "events": 1, "denominator": 50, "estimate": 2.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "EYE LASER SURGERY", "soc": "SURGICAL AND MEDICAL PROCEDURES", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "SKIN LESION EXCISION", "soc": "SURGICAL AND MEDICAL PROCEDURES", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "HOT FLUSH", "soc": "VASCULAR DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "HYPERTENSION", "soc": "VASCULAR DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 50, "estimate": 2.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "HYPOTENSION", "soc": "VASCULAR DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 50, "estimate": 2.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "ORTHOSTATIC HYPOTENSION", "soc": "VASCULAR DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline Low Dose", "measure": "WOUND HAEMORRHAGE", "soc": "VASCULAR DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 50, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "Any treatment-emergent AE", "soc": "", "level": "Any", "n": 36, "events": 164, "denominator": 40, "estimate": 90.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "CARDIAC DISORDERS", "soc": "CARDIAC DISORDERS", "level": "SOC", "n": 6, "events": 7, "denominator": 40, "estimate": 15.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "CONGENITAL, FAMILIAL AND GENETIC DISORDERS", "soc": "CONGENITAL, FAMILIAL AND GENETIC DISORDERS", "level": "SOC", "n": 1, "events": 1, "denominator": 40, "estimate": 2.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "EAR AND LABYRINTH DISORDERS", "soc": "EAR AND LABYRINTH DISORDERS", "level": "SOC", "n": 1, "events": 1, "denominator": 40, "estimate": 2.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "EYE DISORDERS", "soc": "EYE DISORDERS", "level": "SOC", "n": 1, "events": 2, "denominator": 40, "estimate": 2.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "GASTROINTESTINAL DISORDERS", "soc": "GASTROINTESTINAL DISORDERS", "level": "SOC", "n": 7, "events": 14, "denominator": 40, "estimate": 17.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "SOC", "n": 20, "events": 64, "denominator": 40, "estimate": 50.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "HEPATOBILIARY DISORDERS", "soc": "HEPATOBILIARY DISORDERS", "level": "SOC", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "IMMUNE SYSTEM DISORDERS", "soc": "IMMUNE SYSTEM DISORDERS", "level": "SOC", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "INFECTIONS AND INFESTATIONS", "soc": "INFECTIONS AND INFESTATIONS", "level": "SOC", "n": 4, "events": 7, "denominator": 40, "estimate": 10.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "soc": "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "level": "SOC", "n": 2, "events": 2, "denominator": 40, "estimate": 5.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "INVESTIGATIONS", "soc": "INVESTIGATIONS", "level": "SOC", "n": 2, "events": 2, "denominator": 40, "estimate": 5.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "METABOLISM AND NUTRITION DISORDERS", "soc": "METABOLISM AND NUTRITION DISORDERS", "level": "SOC", "n": 1, "events": 2, "denominator": 40, "estimate": 2.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "soc": "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "level": "SOC", "n": 2, "events": 2, "denominator": 40, "estimate": 5.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)", "soc": "NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)", "level": "SOC", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "NERVOUS SYSTEM DISORDERS", "soc": "NERVOUS SYSTEM DISORDERS", "level": "SOC", "n": 11, "events": 20, "denominator": 40, "estimate": 27.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "PSYCHIATRIC DISORDERS", "soc": "PSYCHIATRIC DISORDERS", "level": "SOC", "n": 2, "events": 2, "denominator": 40, "estimate": 5.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "RENAL AND URINARY DISORDERS", "soc": "RENAL AND URINARY DISORDERS", "level": "SOC", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "REPRODUCTIVE SYSTEM AND BREAST DISORDERS", "soc": "REPRODUCTIVE SYSTEM AND BREAST DISORDERS", "level": "SOC", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "SOC", "n": 2, "events": 3, "denominator": 40, "estimate": 5.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "SOC", "n": 13, "events": 32, "denominator": 40, "estimate": 32.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "SOCIAL CIRCUMSTANCES", "soc": "SOCIAL CIRCUMSTANCES", "level": "SOC", "n": 1, "events": 1, "denominator": 40, "estimate": 2.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "SURGICAL AND MEDICAL PROCEDURES", "soc": "SURGICAL AND MEDICAL PROCEDURES", "level": "SOC", "n": 1, "events": 1, "denominator": 40, "estimate": 2.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "VASCULAR DISORDERS", "soc": "VASCULAR DISORDERS", "level": "SOC", "n": 1, "events": 1, "denominator": 40, "estimate": 2.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "ATRIAL FIBRILLATION", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 2, "events": 3, "denominator": 40, "estimate": 5.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "ATRIAL FLUTTER", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "ATRIAL HYPERTROPHY", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 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"estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "CARDIAC DISORDER", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "CARDIAC FAILURE CONGESTIVE", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "MYOCARDIAL INFARCTION", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 40, "estimate": 2.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "PALPITATIONS", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "SINUS ARRHYTHMIA", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "SINUS BRADYCARDIA", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 2, "events": 2, "denominator": 40, "estimate": 5.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "SUPRAVENTRICULAR EXTRASYSTOLES", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 40, "estimate": 2.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "SUPRAVENTRICULAR TACHYCARDIA", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "TACHYCARDIA", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "VENTRICULAR EXTRASYSTOLES", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "VENTRICULAR HYPERTROPHY", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "WOLFF-PARKINSON-WHITE SYNDROME", "soc": "CARDIAC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "VENTRICULAR SEPTAL DEFECT", "soc": "CONGENITAL, FAMILIAL AND GENETIC DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 40, "estimate": 2.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "CERUMEN IMPACTION", "soc": "EAR AND LABYRINTH DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "EAR PAIN", "soc": "EAR AND LABYRINTH DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "TINNITUS", "soc": "EAR AND LABYRINTH DISORDERS", "level": "PT", "n": 0, 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"measure": "EYE SWELLING", "soc": "EYE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "GLAUCOMA", "soc": "EYE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "VISION BLURRED", "soc": "EYE DISORDERS", "level": "PT", "n": 1, "events": 2, "denominator": 40, "estimate": 2.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "ABDOMINAL DISCOMFORT", "soc": "GASTROINTESTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "ABDOMINAL PAIN", "soc": "GASTROINTESTINAL DISORDERS", "level": "PT", "n": 1, "events": 2, "denominator": 40, "estimate": 2.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "CONSTIPATION", "soc": "GASTROINTESTINAL DISORDERS", "level": "PT", "n": 0, "events": 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"arm": "Xanomeline High Dose", "measure": "GASTROOESOPHAGEAL REFLUX DISEASE", "soc": "GASTROINTESTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "GLOSSITIS", "soc": "GASTROINTESTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "HIATUS HERNIA", "soc": "GASTROINTESTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "NAUSEA", "soc": "GASTROINTESTINAL DISORDERS", "level": "PT", "n": 4, "events": 10, "denominator": 40, "estimate": 10.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "RECTAL HAEMORRHAGE", "soc": "GASTROINTESTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "SALIVARY HYPERSECRETION", "soc": "GASTROINTESTINAL DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 40, "estimate": 2.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "STOMACH DISCOMFORT", "soc": "GASTROINTESTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "VOMITING", "soc": "GASTROINTESTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "APPLICATION SITE BLEEDING", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "APPLICATION SITE DERMATITIS", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 4, "events": 9, "denominator": 40, "estimate": 10.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "APPLICATION SITE DESQUAMATION", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "APPLICATION SITE DISCHARGE", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "APPLICATION SITE DISCOLOURATION", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "APPLICATION SITE ERYTHEMA", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 5, "events": 9, "denominator": 40, "estimate": 12.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "APPLICATION SITE INDURATION", "soc": "GENERAL 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"measure": "APPLICATION SITE WARMTH", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "ASTHENIA", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 1, "events": 1, "denominator": 40, "estimate": 2.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "CHEST DISCOMFORT", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 1, "events": 1, "denominator": 40, "estimate": 2.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "CHEST PAIN", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 1, "events": 1, "denominator": 40, "estimate": 2.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "CHILLS", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "CYST", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "FATIGUE", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 4, "events": 4, "denominator": 40, "estimate": 10.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "FEELING ABNORMAL", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "FEELING COLD", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "INFLAMMATION", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE 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"soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "SECRETION DISCHARGE", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "SUDDEN DEATH", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "SWELLING", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "ULCER", "soc": "GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "HYPERBILIRUBINAEMIA", "soc": "HEPATOBILIARY DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "HYPERSENSITIVITY", "soc": "IMMUNE SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "SEASONAL ALLERGY", "soc": "IMMUNE SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "BRONCHITIS", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "CELLULITIS", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "CERVICITIS", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "CYSTITIS", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 1, "events": 1, "denominator": 40, "estimate": 2.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "EAR INFECTION", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "GASTROENTERITIS VIRAL", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "HORDEOLUM", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "INFLUENZA", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "LOCALISED INFECTION", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "LOWER RESPIRATORY TRACT INFECTION", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "NASOPHARYNGITIS", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 3, "events": 4, "denominator": 40, "estimate": 7.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "ONYCHOMYCOSIS", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "PNEUMONIA", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "RHINITIS", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "UPPER RESPIRATORY TRACT INFECTION", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 1, "events": 2, "denominator": 40, "estimate": 2.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "URINARY TRACT INFECTION", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "VAGINAL MYCOSIS", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "VIRAL INFECTION", "soc": "INFECTIONS AND INFESTATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "CONTUSION", "soc": "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "EXCORIATION", "soc": "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "level": "PT", "n": 1, "events": 1, "denominator": 40, "estimate": 2.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "FACIAL BONES FRACTURE", "soc": "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "FALL", "soc": "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "HIP FRACTURE", "soc": "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "level": "PT", "n": 1, "events": 1, "denominator": 40, "estimate": 2.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "JOINT DISLOCATION", "soc": "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "SKIN LACERATION", "soc": "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "WOUND", "soc": "INJURY, POISONING AND PROCEDURAL COMPLICATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "BIOPSY", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "BIOPSY PROSTATE", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "BLOOD ALKALINE PHOSPHATASE INCREASED", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "BLOOD CHOLESTEROL INCREASED", "soc": "INVESTIGATIONS", "level": "PT", "n": 1, "events": 1, "denominator": 40, "estimate": 2.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "BLOOD CREATINE PHOSPHOKINASE INCREASED", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "BLOOD GLUCOSE INCREASED", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "BLOOD URINE PRESENT", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "BODY TEMPERATURE INCREASED", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "CYSTOSCOPY", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "ELECTROCARDIOGRAM ST SEGMENT DEPRESSION", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "ELECTROCARDIOGRAM T WAVE INVERSION", "soc": "INVESTIGATIONS", "level": "PT", "n": 1, "events": 1, "denominator": 40, "estimate": 2.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "HEART RATE INCREASED", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "HEART RATE IRREGULAR", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "NASAL MUCOSA BIOPSY", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "NEUTROPHIL COUNT INCREASED", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "URINE ANALYSIS ABNORMAL", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "WEIGHT DECREASED", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "WHITE BLOOD CELL COUNT INCREASED", "soc": "INVESTIGATIONS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "DECREASED APPETITE", "soc": "METABOLISM AND NUTRITION DISORDERS", "level": "PT", "n": 1, "events": 2, "denominator": 40, "estimate": 2.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "DEHYDRATION", "soc": "METABOLISM AND NUTRITION DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "DIABETES MELLITUS", "soc": "METABOLISM AND NUTRITION DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "FOOD CRAVING", "soc": "METABOLISM AND NUTRITION DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "HYPERCHOLESTEROLAEMIA", "soc": "METABOLISM AND NUTRITION DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "HYPONATRAEMIA", "soc": "METABOLISM AND NUTRITION DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "INCREASED APPETITE", "soc": "METABOLISM AND NUTRITION DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "ARTHRALGIA", "soc": "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "ARTHRITIS", "soc": "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 40, "estimate": 2.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "BACK PAIN", "soc": "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 40, "estimate": 2.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "FLANK PAIN", "soc": "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "MUSCLE SPASMS", "soc": "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "MUSCULAR WEAKNESS", "soc": "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "MYALGIA", "soc": "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "PAIN IN EXTREMITY", "soc": "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "SHOULDER PAIN", "soc": "MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "COLON CANCER", "soc": "NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "MALIGNANT FIBROUS HISTIOCYTOMA", "soc": "NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "PROSTATE CANCER", "soc": "NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "AMNESIA", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 1, "events": 2, "denominator": 40, "estimate": 2.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "BALANCE DISORDER", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "BURNING SENSATION", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "COGNITIVE DISORDER", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "COMPLEX PARTIAL SEIZURES", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "COORDINATION ABNORMAL", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "DIZZINESS", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 3, "events": 3, "denominator": 40, "estimate": 7.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "HEADACHE", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 4, "events": 7, "denominator": 40, "estimate": 10.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "HEMIANOPIA HOMONYMOUS", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "HYPERSOMNIA", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 40, "estimate": 2.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "LETHARGY", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 40, "estimate": 2.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "PARAESTHESIA", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "PARAESTHESIA ORAL", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "PARKINSON'S DISEASE", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "PAROSMIA", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "PARTIAL SEIZURES WITH SECONDARY GENERALISATION", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 40, "estimate": 2.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "PSYCHOMOTOR HYPERACTIVITY", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "SOMNOLENCE", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "STUPOR", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "SYNCOPE", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 2, "events": 3, "denominator": 40, "estimate": 5.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "SYNCOPE VASOVAGAL", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 40, "estimate": 2.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "TRANSIENT ISCHAEMIC ATTACK", "soc": "NERVOUS SYSTEM DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 40, "estimate": 2.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "AGITATION", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 40, "estimate": 2.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "ANXIETY", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "COMPLETED SUICIDE", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "CONFUSIONAL STATE", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "DELIRIUM", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "DELUSION", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "DEPRESSED MOOD", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "DISORIENTATION", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "HALLUCINATION", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "HALLUCINATION, VISUAL", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 40, "estimate": 2.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "INSOMNIA", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "IRRITABILITY", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "LIBIDO DECREASED", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "LISTLESS", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "NIGHTMARE", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "RESTLESSNESS", "soc": "PSYCHIATRIC DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "CALCULUS URETHRAL", "soc": "RENAL AND URINARY DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "DYSURIA", "soc": "RENAL AND URINARY DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "ENURESIS", "soc": "RENAL AND URINARY DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "INCONTINENCE", "soc": "RENAL AND URINARY DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "MICTURITION URGENCY", "soc": "RENAL AND URINARY DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "NEPHROLITHIASIS", "soc": "RENAL AND URINARY DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "POLLAKIURIA", "soc": "RENAL AND URINARY DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "BENIGN PROSTATIC HYPERPLASIA", "soc": "REPRODUCTIVE SYSTEM AND BREAST DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "PELVIC PAIN", "soc": "REPRODUCTIVE SYSTEM AND BREAST DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "ALLERGIC GRANULOMATOUS ANGIITIS", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "COUGH", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 1, "events": 1, "denominator": 40, "estimate": 2.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "DYSPHONIA", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "DYSPNOEA", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "EMPHYSEMA", "soc": "RESPIRATORY, 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"measure": "PHARYNGOLARYNGEAL PAIN", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "POSTNASAL DRIP", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "PRODUCTIVE COUGH", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "RALES", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "RESPIRATORY TRACT CONGESTION", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "RHINORRHOEA", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 1, "events": 2, "denominator": 40, "estimate": 2.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "ACTINIC KERATOSIS", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "ALOPECIA", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "BLISTER", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "COLD SWEAT", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "DERMATITIS ATOPIC", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "DERMATITIS CONTACT", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "DRUG ERUPTION", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 40, "estimate": 0.0 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "ERYTHEMA", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 7, "events": 8, "denominator": 40, "estimate": 17.5 }, { "stratum": "F", "arm": "Xanomeline High Dose", "measure": "HYPERHIDROSIS", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 2, "events": 2, "denominator": 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"measure": "RALES", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 34, "estimate": 0.0 }, { "stratum": "M", "arm": "Xanomeline Low Dose", "measure": "RESPIRATORY TRACT CONGESTION", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 34, "estimate": 0.0 }, { "stratum": "M", "arm": "Xanomeline Low Dose", "measure": "RHINORRHOEA", "soc": "RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 34, "estimate": 0.0 }, { "stratum": "M", "arm": "Xanomeline Low Dose", "measure": "ACTINIC KERATOSIS", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 34, "estimate": 0.0 }, { "stratum": "M", "arm": "Xanomeline Low Dose", "measure": "ALOPECIA", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 34, "estimate": 0.0 }, { "stratum": "M", "arm": "Xanomeline Low Dose", "measure": "BLISTER", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 3, "events": 5, "denominator": 34, "estimate": 8.823529411764707 }, { "stratum": "M", "arm": "Xanomeline Low Dose", "measure": "COLD SWEAT", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 34, "estimate": 0.0 }, { "stratum": "M", "arm": "Xanomeline Low Dose", "measure": "DERMATITIS ATOPIC", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 34, "estimate": 0.0 }, { "stratum": "M", "arm": "Xanomeline Low Dose", "measure": "DERMATITIS CONTACT", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 1, "events": 2, "denominator": 34, "estimate": 2.9411764705882355 }, { "stratum": "M", "arm": "Xanomeline Low Dose", "measure": "DRUG ERUPTION", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 0, "events": 0, "denominator": 34, "estimate": 0.0 }, { "stratum": "M", "arm": "Xanomeline Low Dose", "measure": "ERYTHEMA", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 6, "events": 8, "denominator": 34, "estimate": 17.647058823529413 }, { "stratum": "M", "arm": "Xanomeline Low Dose", "measure": "HYPERHIDROSIS", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 3, "events": 4, "denominator": 34, "estimate": 8.823529411764707 }, { "stratum": "M", "arm": "Xanomeline Low Dose", "measure": "PRURITUS", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 10, "events": 12, "denominator": 34, "estimate": 29.41176470588235 }, { "stratum": "M", "arm": "Xanomeline Low Dose", "measure": "PRURITUS GENERALISED", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 1, "events": 4, "denominator": 34, "estimate": 2.9411764705882355 }, { "stratum": "M", "arm": "Xanomeline Low Dose", "measure": "RASH", "soc": "SKIN AND SUBCUTANEOUS TISSUE DISORDERS", "level": "PT", "n": 5, 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"stratum": "M", "arm": "Xanomeline High Dose", "measure": "CARDIAC DISORDERS", "soc": "CARDIAC DISORDERS", "level": "SOC", "n": 9, "events": 23, "denominator": 44, "estimate": 20.454545454545453 }, { "stratum": "M", "arm": "Xanomeline High Dose", "measure": "CONGENITAL, FAMILIAL AND GENETIC DISORDERS", "soc": "CONGENITAL, FAMILIAL AND GENETIC DISORDERS", "level": "SOC", "n": 1, "events": 1, "denominator": 44, "estimate": 2.272727272727273 }, { "stratum": "M", "arm": "Xanomeline High Dose", "measure": "EAR AND LABYRINTH DISORDERS", "soc": "EAR AND LABYRINTH DISORDERS", "level": "SOC", "n": 0, "events": 0, "denominator": 44, "estimate": 0.0 }, { "stratum": "M", "arm": "Xanomeline High Dose", "measure": "EYE DISORDERS", "soc": "EYE DISORDERS", "level": "SOC", "n": 0, "events": 0, "denominator": 44, "estimate": 0.0 }, { "stratum": "M", "arm": "Xanomeline High Dose", "measure": "GASTROINTESTINAL DISORDERS", "soc": "GASTROINTESTINAL DISORDERS", "level": "SOC", "n": 13, "events": 22, 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