14-5.01

Incidence of Treatment Emergent Adverse Events by Treatment Group

Made 2026-10-17 from uploaded data.

CDISCPILOT01

Table 14-5.01

Incidence of Treatment Emergent Adverse Events by Treatment Group

Safety Analysis Set

				Fisher's Exact p-values
	Placebo (N=86)	Xanomeline Low (N=84)	Xanomeline High (N=84)	Placebo vs. Low Dose	Placebo vs. High Dose
ANY BODY SYSTEM	65 (75.6%) [281]	77 (91.7%) [412]	76 (90.5%) [433]	0.007	0.014

CARDIAC DISORDERS	12 (14.0%) [26]	13 (15.5%) [30]	15 (17.9%) [30]	0.831	0.534
ATRIAL FIBRILLATION	1 (1.2%) [1]	1 (1.2%) [1]	3 (3.6%) [5]	>0.999	0.365
ATRIAL FLUTTER	0 (0.0%) [0]	1 (1.2%) [1]	1 (1.2%) [2]	0.494	0.494
ATRIAL HYPERTROPHY	1 (1.2%) [2]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
ATRIOVENTRICULAR BLOCK FIRST DEGREE	1 (1.2%) [1]	1 (1.2%) [1]	0 (0.0%) [0]	>0.999	>0.999
ATRIOVENTRICULAR BLOCK SECOND DEGREE	1 (1.2%) [1]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
BRADYCARDIA	1 (1.2%) [4]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
BUNDLE BRANCH BLOCK LEFT	1 (1.2%) [1]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
BUNDLE BRANCH BLOCK RIGHT	1 (1.2%) [2]	1 (1.2%) [1]	0 (0.0%) [0]	>0.999	>0.999
CARDIAC DISORDER	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
CARDIAC FAILURE CONGESTIVE	1 (1.2%) [1]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
MYOCARDIAL INFARCTION	4 (4.7%) [4]	2 (2.4%) [4]	4 (4.8%) [8]	0.682	>0.999
PALPITATIONS	0 (0.0%) [0]	2 (2.4%) [2]	0 (0.0%) [0]	0.243	>0.999
SINUS ARRHYTHMIA	1 (1.2%) [2]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
SINUS BRADYCARDIA	2 (2.3%) [2]	7 (8.3%) [10]	8 (9.5%) [12]	0.097	0.056
SUPRAVENTRICULAR EXTRASYSTOLES	1 (1.2%) [2]	1 (1.2%) [2]	1 (1.2%) [1]	>0.999	>0.999
SUPRAVENTRICULAR TACHYCARDIA	0 (0.0%) [0]	1 (1.2%) [2]	0 (0.0%) [0]	0.494	>0.999
TACHYCARDIA	1 (1.2%) [2]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
VENTRICULAR EXTRASYSTOLES	0 (0.0%) [0]	2 (2.4%) [4]	1 (1.2%) [1]	0.243	0.494
VENTRICULAR HYPERTROPHY	1 (1.2%) [1]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
WOLFF-PARKINSON-WHITE SYNDROME	0 (0.0%) [0]	1 (1.2%) [2]	0 (0.0%) [0]	0.494	>0.999
CONGENITAL, FAMILIAL AND GENETIC DISORDERS	0 (0.0%) [0]	1 (1.2%) [1]	2 (2.4%) [2]	0.494	0.243
VENTRICULAR SEPTAL DEFECT	0 (0.0%) [0]	1 (1.2%) [1]	2 (2.4%) [2]	0.494	0.243
EAR AND LABYRINTH DISORDERS	1 (1.2%) [2]	2 (2.4%) [2]	1 (1.2%) [1]	0.618	>0.999
CERUMEN IMPACTION	0 (0.0%) [0]	1 (1.2%) [1]	0 (0.0%) [0]	0.494	>0.999
EAR PAIN	1 (1.2%) [2]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
VERTIGO	0 (0.0%) [0]	1 (1.2%) [1]	1 (1.2%) [1]	0.494	0.494
EYE DISORDERS	2 (2.3%) [5]	2 (2.4%) [2]	1 (1.2%) [2]	>0.999	>0.999
CONJUNCTIVAL HAEMORRHAGE	0 (0.0%) [0]	1 (1.2%) [1]	0 (0.0%) [0]	0.494	>0.999
CONJUNCTIVITIS	1 (1.2%) [2]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
EYE ALLERGY	1 (1.2%) [1]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
EYE PRURITUS	1 (1.2%) [1]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
EYE SWELLING	1 (1.2%) [1]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
VISION BLURRED	0 (0.0%) [0]	1 (1.2%) [1]	1 (1.2%) [2]	0.494	0.494
GASTROINTESTINAL DISORDERS	17 (19.8%) [26]	14 (16.7%) [22]	20 (23.8%) [36]	0.692	0.580
ABDOMINAL DISCOMFORT	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
ABDOMINAL PAIN	1 (1.2%) [1]	3 (3.6%) [3]	1 (1.2%) [2]	0.365	>0.999
CONSTIPATION	1 (1.2%) [1]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
DIARRHOEA	9 (10.5%) [10]	4 (4.8%) [5]	4 (4.8%) [4]	0.248	0.248
DYSPEPSIA	1 (1.2%) [2]	1 (1.2%) [2]	0 (0.0%) [0]	>0.999	>0.999
DYSPHAGIA	0 (0.0%) [0]	1 (1.2%) [1]	0 (0.0%) [0]	0.494	>0.999
FLATULENCE	1 (1.2%) [2]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
GASTROINTESTINAL HAEMORRHAGE	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
GASTROOESOPHAGEAL REFLUX DISEASE	1 (1.2%) [1]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
GLOSSITIS	1 (1.2%) [1]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
HIATUS HERNIA	1 (1.2%) [2]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
NAUSEA	3 (3.5%) [3]	3 (3.6%) [5]	6 (7.1%) [13]	>0.999	0.326
RECTAL HAEMORRHAGE	0 (0.0%) [0]	1 (1.2%) [2]	0 (0.0%) [0]	0.494	>0.999
SALIVARY HYPERSECRETION	0 (0.0%) [0]	0 (0.0%) [0]	4 (4.8%) [5]	>0.999	0.057
STOMACH DISCOMFORT	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
VOMITING	3 (3.5%) [3]	3 (3.6%) [4]	7 (8.3%) [9]	>0.999	0.208
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	21 (24.4%) [46]	47 (56.0%) [118]	40 (47.6%) [124]	<0.001	0.002
APPLICATION SITE BLEEDING	0 (0.0%) [0]	1 (1.2%) [1]	0 (0.0%) [0]	0.494	>0.999
APPLICATION SITE DERMATITIS	5 (5.8%) [9]	9 (10.7%) [15]	7 (8.3%) [12]	0.277	0.563
APPLICATION SITE DESQUAMATION	0 (0.0%) [0]	1 (1.2%) [1]	0 (0.0%) [0]	0.494	>0.999
APPLICATION SITE DISCHARGE	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
APPLICATION SITE DISCOLOURATION	0 (0.0%) [0]	1 (1.2%) [1]	0 (0.0%) [0]	0.494	>0.999
APPLICATION SITE ERYTHEMA	3 (3.5%) [3]	12 (14.3%) [20]	15 (17.9%) [23]	0.015	0.002
APPLICATION SITE INDURATION	1 (1.2%) [1]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
APPLICATION SITE IRRITATION	3 (3.5%) [7]	9 (10.7%) [18]	9 (10.7%) [16]	0.078	0.078
APPLICATION SITE PAIN	0 (0.0%) [0]	0 (0.0%) [0]	2 (2.4%) [2]	>0.999	0.243
APPLICATION SITE PERSPIRATION	0 (0.0%) [0]	0 (0.0%) [0]	2 (2.4%) [3]	>0.999	0.243
APPLICATION SITE PRURITUS	6 (7.0%) [10]	22 (26.2%) [32]	22 (26.2%) [35]	0.001	0.001
APPLICATION SITE REACTION	1 (1.2%) [2]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	>0.999
APPLICATION SITE SWELLING	0 (0.0%) [0]	1 (1.2%) [1]	2 (2.4%) [3]	0.494	0.243
APPLICATION SITE URTICARIA	0 (0.0%) [0]	2 (2.4%) [2]	1 (1.2%) [1]	0.243	0.494
APPLICATION SITE VESICLES	1 (1.2%) [2]	4 (4.8%) [5]	6 (7.1%) [6]	0.208	0.062
APPLICATION SITE WARMTH	0 (0.0%) [0]	1 (1.2%) [2]	0 (0.0%) [0]	0.494	>0.999
ASTHENIA	1 (1.2%) [2]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	>0.999
CHEST DISCOMFORT	0 (0.0%) [0]	0 (0.0%) [0]	2 (2.4%) [2]	>0.999	0.243
CHEST PAIN	0 (0.0%) [0]	0 (0.0%) [0]	2 (2.4%) [2]	>0.999	0.243
CHILLS	1 (1.2%) [3]	1 (1.2%) [2]	1 (1.2%) [1]	>0.999	>0.999
FATIGUE	1 (1.2%) [2]	5 (6.0%) [5]	5 (6.0%) [5]	0.115	0.115
FEELING ABNORMAL	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
FEELING COLD	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
INFLAMMATION	0 (0.0%) [0]	1 (1.2%) [1]	0 (0.0%) [0]	0.494	>0.999
MALAISE	0 (0.0%) [0]	1 (1.2%) [2]	2 (2.4%) [3]	0.494	0.243
OEDEMA	0 (0.0%) [0]	2 (2.4%) [2]	0 (0.0%) [0]	0.243	>0.999
OEDEMA PERIPHERAL	2 (2.3%) [3]	1 (1.2%) [1]	2 (2.4%) [3]	>0.999	>0.999
PAIN	0 (0.0%) [0]	1 (1.2%) [2]	1 (1.2%) [1]	0.494	0.494
PYREXIA	2 (2.3%) [2]	0 (0.0%) [0]	1 (1.2%) [1]	0.497	>0.999
SECRETION DISCHARGE	0 (0.0%) [0]	1 (1.2%) [2]	0 (0.0%) [0]	0.494	>0.999
SUDDEN DEATH	0 (0.0%) [0]	1 (1.2%) [1]	0 (0.0%) [0]	0.494	>0.999
SWELLING	0 (0.0%) [0]	1 (1.2%) [1]	0 (0.0%) [0]	0.494	>0.999
ULCER	0 (0.0%) [0]	1 (1.2%) [1]	0 (0.0%) [0]	0.494	>0.999
HEPATOBILIARY DISORDERS	1 (1.2%) [1]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
HYPERBILIRUBINAEMIA	1 (1.2%) [1]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
IMMUNE SYSTEM DISORDERS	0 (0.0%) [0]	1 (1.2%) [2]	0 (0.0%) [0]	0.494	>0.999
HYPERSENSITIVITY	0 (0.0%) [0]	1 (1.2%) [2]	0 (0.0%) [0]	0.494	>0.999
INFECTIONS AND INFESTATIONS	16 (18.6%) [35]	9 (10.7%) [16]	13 (15.5%) [20]	0.194	0.685
BRONCHITIS	1 (1.2%) [1]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
CELLULITIS	0 (0.0%) [0]	1 (1.2%) [1]	0 (0.0%) [0]	0.494	>0.999
CERVICITIS	1 (1.2%) [2]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
CYSTITIS	1 (1.2%) [1]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	>0.999
EAR INFECTION	2 (2.3%) [4]	0 (0.0%) [0]	0 (0.0%) [0]	0.497	0.497
GASTROENTERITIS VIRAL	1 (1.2%) [1]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
HORDEOLUM	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
INFLUENZA	1 (1.2%) [2]	1 (1.2%) [1]	1 (1.2%) [1]	>0.999	>0.999
LOCALISED INFECTION	1 (1.2%) [2]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
LOWER RESPIRATORY TRACT INFECTION	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [2]	>0.999	0.494
NASOPHARYNGITIS	2 (2.3%) [4]	4 (4.8%) [9]	6 (7.1%) [8]	0.441	0.166
PNEUMONIA	0 (0.0%) [0]	1 (1.2%) [2]	0 (0.0%) [0]	0.494	>0.999
RHINITIS	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
UPPER RESPIRATORY TRACT INFECTION	6 (7.0%) [12]	1 (1.2%) [2]	3 (3.6%) [5]	0.117	0.496
URINARY TRACT INFECTION	2 (2.3%) [4]	0 (0.0%) [0]	1 (1.2%) [1]	0.497	>0.999
VAGINAL MYCOSIS	1 (1.2%) [2]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
VIRAL INFECTION	0 (0.0%) [0]	1 (1.2%) [1]	0 (0.0%) [0]	0.494	>0.999
INJURY, POISONING AND PROCEDURAL COMPLICATIONS	4 (4.7%) [9]	5 (6.0%) [12]	5 (6.0%) [8]	0.745	0.745
CONTUSION	1 (1.2%) [1]	1 (1.2%) [3]	2 (2.4%) [3]	>0.999	0.618
EXCORIATION	2 (2.3%) [3]	1 (1.2%) [2]	1 (1.2%) [1]	>0.999	>0.999
FACIAL BONES FRACTURE	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
FALL	1 (1.2%) [2]	2 (2.4%) [2]	1 (1.2%) [1]	0.618	>0.999
HIP FRACTURE	1 (1.2%) [2]	0 (0.0%) [0]	2 (2.4%) [2]	>0.999	0.618
JOINT DISLOCATION	0 (0.0%) [0]	1 (1.2%) [1]	0 (0.0%) [0]	0.494	>0.999
SKIN LACERATION	1 (1.2%) [1]	2 (2.4%) [2]	0 (0.0%) [0]	0.618	>0.999
WOUND	0 (0.0%) [0]	1 (1.2%) [2]	0 (0.0%) [0]	0.494	>0.999
INVESTIGATIONS	10 (11.6%) [19]	6 (7.1%) [7]	6 (7.1%) [8]	0.432	0.432
BIOPSY	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
BIOPSY PROSTATE	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
BLOOD ALKALINE PHOSPHATASE INCREASED	1 (1.2%) [1]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
BLOOD CHOLESTEROL INCREASED	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
BLOOD CREATINE PHOSPHOKINASE INCREASED	1 (1.2%) [2]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
BLOOD GLUCOSE INCREASED	0 (0.0%) [0]	1 (1.2%) [1]	1 (1.2%) [2]	0.494	0.494
BLOOD URINE PRESENT	1 (1.2%) [1]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
BODY TEMPERATURE INCREASED	0 (0.0%) [0]	1 (1.2%) [1]	0 (0.0%) [0]	0.494	>0.999
CYSTOSCOPY	1 (1.2%) [1]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
ELECTROCARDIOGRAM ST SEGMENT DEPRESSION	4 (4.7%) [4]	1 (1.2%) [2]	0 (0.0%) [0]	0.368	0.121
ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED	1 (1.2%) [1]	1 (1.2%) [1]	0 (0.0%) [0]	>0.999	>0.999
ELECTROCARDIOGRAM T WAVE INVERSION	2 (2.3%) [3]	1 (1.2%) [1]	1 (1.2%) [1]	>0.999	>0.999
HEART RATE INCREASED	1 (1.2%) [2]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
HEART RATE IRREGULAR	1 (1.2%) [4]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
NASAL MUCOSA BIOPSY	0 (0.0%) [0]	1 (1.2%) [1]	0 (0.0%) [0]	0.494	>0.999
WEIGHT DECREASED	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [2]	>0.999	0.494
METABOLISM AND NUTRITION DISORDERS	6 (7.0%) [8]	1 (1.2%) [1]	2 (2.4%) [4]	0.117	0.278
DECREASED APPETITE	1 (1.2%) [2]	0 (0.0%) [0]	1 (1.2%) [2]	>0.999	>0.999
DEHYDRATION	1 (1.2%) [1]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
DIABETES MELLITUS	1 (1.2%) [1]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
FOOD CRAVING	1 (1.2%) [1]	1 (1.2%) [1]	0 (0.0%) [0]	>0.999	>0.999
HYPONATRAEMIA	1 (1.2%) [1]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
INCREASED APPETITE	1 (1.2%) [2]	0 (0.0%) [0]	1 (1.2%) [2]	>0.999	>0.999
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	4 (4.7%) [6]	7 (8.3%) [10]	7 (8.3%) [10]	0.367	0.367
ARTHRALGIA	1 (1.2%) [1]	2 (2.4%) [4]	1 (1.2%) [1]	0.618	>0.999
ARTHRITIS	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
BACK PAIN	1 (1.2%) [2]	1 (1.2%) [1]	3 (3.6%) [4]	>0.999	0.365
FLANK PAIN	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
MUSCLE SPASMS	0 (0.0%) [0]	1 (1.2%) [1]	1 (1.2%) [2]	0.494	0.494
MUSCULAR WEAKNESS	0 (0.0%) [0]	1 (1.2%) [2]	0 (0.0%) [0]	0.494	>0.999
MYALGIA	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
PAIN IN EXTREMITY	1 (1.2%) [1]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
SHOULDER PAIN	1 (1.2%) [2]	2 (2.4%) [2]	0 (0.0%) [0]	0.618	>0.999
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)	0 (0.0%) [0]	2 (2.4%) [3]	1 (1.2%) [1]	0.243	0.494
COLON CANCER	0 (0.0%) [0]	1 (1.2%) [1]	0 (0.0%) [0]	0.494	>0.999
MALIGNANT FIBROUS HISTIOCYTOMA	0 (0.0%) [0]	1 (1.2%) [2]	0 (0.0%) [0]	0.494	>0.999
PROSTATE CANCER	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
NERVOUS SYSTEM DISORDERS	8 (9.3%) [11]	20 (23.8%) [40]	25 (29.8%) [41]	0.013	0.001
AMNESIA	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [2]	>0.999	0.494
BALANCE DISORDER	0 (0.0%) [0]	1 (1.2%) [3]	0 (0.0%) [0]	0.494	>0.999
BURNING SENSATION	0 (0.0%) [0]	0 (0.0%) [0]	2 (2.4%) [2]	>0.999	0.243
COGNITIVE DISORDER	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
COMPLEX PARTIAL SEIZURES	0 (0.0%) [0]	1 (1.2%) [1]	0 (0.0%) [0]	0.494	>0.999
COORDINATION ABNORMAL	0 (0.0%) [0]	1 (1.2%) [1]	0 (0.0%) [0]	0.494	>0.999
DIZZINESS	2 (2.3%) [3]	8 (9.5%) [13]	11 (13.1%) [15]	0.056	0.009
HEADACHE	3 (3.5%) [3]	3 (3.6%) [4]	5 (6.0%) [8]	>0.999	0.493
HEMIANOPIA HOMONYMOUS	0 (0.0%) [0]	1 (1.2%) [1]	0 (0.0%) [0]	0.494	>0.999
HYPERSOMNIA	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
LETHARGY	0 (0.0%) [0]	1 (1.2%) [1]	1 (1.2%) [1]	0.494	0.494
PARAESTHESIA	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
PARAESTHESIA ORAL	0 (0.0%) [0]	1 (1.2%) [1]	0 (0.0%) [0]	0.494	>0.999
PARKINSON'S DISEASE	1 (1.2%) [1]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
PAROSMIA	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [2]	>0.999	0.494
PARTIAL SEIZURES WITH SECONDARY GENERALISATION	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
PSYCHOMOTOR HYPERACTIVITY	1 (1.2%) [1]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
SOMNOLENCE	2 (2.3%) [3]	3 (3.6%) [5]	1 (1.2%) [1]	0.680	>0.999
STUPOR	0 (0.0%) [0]	1 (1.2%) [1]	0 (0.0%) [0]	0.494	>0.999
SYNCOPE	0 (0.0%) [0]	4 (4.8%) [6]	3 (3.6%) [4]	0.057	0.118
SYNCOPE VASOVAGAL	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
TRANSIENT ISCHAEMIC ATTACK	0 (0.0%) [0]	2 (2.4%) [3]	1 (1.2%) [1]	0.243	0.494
PSYCHIATRIC DISORDERS	10 (11.6%) [12]	10 (11.9%) [14]	8 (9.5%) [11]	>0.999	0.804
AGITATION	2 (2.3%) [2]	2 (2.4%) [2]	1 (1.2%) [1]	>0.999	>0.999
ANXIETY	0 (0.0%) [0]	3 (3.6%) [4]	0 (0.0%) [0]	0.118	>0.999
COMPLETED SUICIDE	1 (1.2%) [1]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
CONFUSIONAL STATE	2 (2.3%) [2]	3 (3.6%) [3]	1 (1.2%) [1]	0.680	>0.999
DELIRIUM	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
DELUSION	1 (1.2%) [1]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	>0.999
DEPRESSED MOOD	0 (0.0%) [0]	1 (1.2%) [2]	0 (0.0%) [0]	0.494	>0.999
DISORIENTATION	1 (1.2%) [1]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
HALLUCINATION	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
HALLUCINATION, VISUAL	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
INSOMNIA	2 (2.3%) [3]	0 (0.0%) [0]	2 (2.4%) [2]	0.497	>0.999
IRRITABILITY	1 (1.2%) [2]	1 (1.2%) [1]	0 (0.0%) [0]	>0.999	>0.999
LIBIDO DECREASED	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
LISTLESS	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
NIGHTMARE	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
RESTLESSNESS	0 (0.0%) [0]	1 (1.2%) [2]	0 (0.0%) [0]	0.494	>0.999
RENAL AND URINARY DISORDERS	4 (4.7%) [5]	3 (3.6%) [3]	3 (3.6%) [4]	>0.999	>0.999
CALCULUS URETHRAL	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
DYSURIA	1 (1.2%) [1]	1 (1.2%) [1]	0 (0.0%) [0]	>0.999	>0.999
INCONTINENCE	0 (0.0%) [0]	1 (1.2%) [1]	0 (0.0%) [0]	0.494	>0.999
MICTURITION URGENCY	1 (1.2%) [1]	1 (1.2%) [1]	1 (1.2%) [2]	>0.999	>0.999
NEPHROLITHIASIS	1 (1.2%) [1]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	>0.999
POLLAKIURIA	1 (1.2%) [2]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
REPRODUCTIVE SYSTEM AND BREAST DISORDERS	2 (2.3%) [4]	0 (0.0%) [0]	1 (1.2%) [1]	0.497	>0.999
BENIGN PROSTATIC HYPERPLASIA	1 (1.2%) [2]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	>0.999
PELVIC PAIN	1 (1.2%) [2]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	8 (9.3%) [12]	9 (10.7%) [14]	10 (11.9%) [22]	0.803	0.626
ALLERGIC GRANULOMATOUS ANGIITIS	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
COUGH	1 (1.2%) [1]	5 (6.0%) [7]	5 (6.0%) [7]	0.115	0.115
DYSPHONIA	0 (0.0%) [0]	1 (1.2%) [1]	0 (0.0%) [0]	0.494	>0.999
DYSPNOEA	1 (1.2%) [1]	1 (1.2%) [1]	1 (1.2%) [1]	>0.999	>0.999
EMPHYSEMA	1 (1.2%) [1]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
EPISTAXIS	0 (0.0%) [0]	1 (1.2%) [1]	2 (2.4%) [2]	0.494	0.243
HAEMOPTYSIS	1 (1.2%) [2]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
NASAL CONGESTION	3 (3.5%) [3]	1 (1.2%) [1]	3 (3.6%) [4]	0.621	>0.999
PHARYNGEAL ERYTHEMA	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [2]	>0.999	0.494
PHARYNGOLARYNGEAL PAIN	0 (0.0%) [0]	1 (1.2%) [1]	1 (1.2%) [1]	0.494	0.494
POSTNASAL DRIP	1 (1.2%) [2]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
PRODUCTIVE COUGH	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
RALES	1 (1.2%) [2]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
RESPIRATORY TRACT CONGESTION	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
RHINORRHOEA	0 (0.0%) [0]	1 (1.2%) [2]	1 (1.2%) [2]	0.494	0.494
SKIN AND SUBCUTANEOUS TISSUE DISORDERS	20 (23.3%) [45]	39 (46.4%) [111]	40 (47.6%) [104]	0.002	0.001
ACTINIC KERATOSIS	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
ALOPECIA	1 (1.2%) [1]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
BLISTER	0 (0.0%) [0]	5 (6.0%) [8]	1 (1.2%) [2]	0.028	0.494
COLD SWEAT	1 (1.2%) [3]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
DERMATITIS CONTACT	0 (0.0%) [0]	1 (1.2%) [2]	0 (0.0%) [0]	0.494	>0.999
DRUG ERUPTION	1 (1.2%) [1]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
ERYTHEMA	8 (9.3%) [12]	14 (16.7%) [22]	14 (16.7%) [22]	0.175	0.175
HYPERHIDROSIS	2 (2.3%) [2]	4 (4.8%) [5]	8 (9.5%) [10]	0.441	0.056
PRURITUS	8 (9.3%) [11]	21 (25.0%) [31]	26 (31.0%) [38]	0.008	<0.001
PRURITUS GENERALISED	0 (0.0%) [0]	1 (1.2%) [4]	1 (1.2%) [1]	0.494	0.494
RASH	5 (5.8%) [9]	13 (15.5%) [18]	9 (10.7%) [15]	0.048	0.277
RASH ERYTHEMATOUS	0 (0.0%) [0]	1 (1.2%) [1]	0 (0.0%) [0]	0.494	>0.999
RASH MACULO-PAPULAR	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
RASH PRURITIC	0 (0.0%) [0]	1 (1.2%) [2]	2 (2.4%) [3]	0.494	0.243
SKIN EXFOLIATION	0 (0.0%) [0]	1 (1.2%) [2]	0 (0.0%) [0]	0.494	>0.999
SKIN IRRITATION	3 (3.5%) [4]	6 (7.1%) [13]	5 (6.0%) [8]	0.326	0.493
SKIN ODOUR ABNORMAL	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
SKIN ULCER	1 (1.2%) [2]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
URTICARIA	0 (0.0%) [0]	1 (1.2%) [3]	1 (1.2%) [2]	0.494	0.494
SOCIAL CIRCUMSTANCES	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
ALCOHOL USE	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
SURGICAL AND MEDICAL PROCEDURES	2 (2.3%) [2]	1 (1.2%) [1]	2 (2.4%) [2]	>0.999	>0.999
ACROCHORDON EXCISION	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
CATARACT OPERATION	1 (1.2%) [1]	1 (1.2%) [1]	0 (0.0%) [0]	>0.999	>0.999
EYE LASER SURGERY	1 (1.2%) [1]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
SKIN LESION EXCISION	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494
VASCULAR DISORDERS	3 (3.5%) [7]	3 (3.6%) [3]	1 (1.2%) [1]	>0.999	0.621
HOT FLUSH	0 (0.0%) [0]	1 (1.2%) [1]	0 (0.0%) [0]	0.494	>0.999
HYPERTENSION	1 (1.2%) [2]	1 (1.2%) [1]	0 (0.0%) [0]	>0.999	>0.999
HYPOTENSION	2 (2.3%) [3]	1 (1.2%) [1]	0 (0.0%) [0]	>0.999	0.497
ORTHOSTATIC HYPOTENSION	1 (1.2%) [2]	0 (0.0%) [0]	0 (0.0%) [0]	>0.999	>0.999
WOUND HAEMORRHAGE	0 (0.0%) [0]	0 (0.0%) [0]	1 (1.2%) [1]	>0.999	0.494

Note: Treatment emergent events are defined as events which start on or after the start of treatment.

Note: Adverse events are coded using MedDRA.

Note: Percentages are based on the number of subjects in the safety population within each treatment group.

Note: P-values are based on Fisher's Exact test for the comparison of placebo versus each active treatment group.

Note: The column [AE] represents the total number of times an event was recorded.

Program: t-14-5-01.sas

Program `t-14-5-01.sas`

Version 1, written from Clinwright's patterns, 2026-10-17, checks passed.

/*==== 00-header ====*/
/*----------------------------------------------------------------------------
  Output  : Table 14-5.01 / Incidence of Treatment Emergent Adverse Events by Treatment Group / Safety Analysis Set
  Program : t-14-5-01.sas   Reporting effort : CSR
  ADaM    : /work/adam (ADSL, ADADAS, ADCIBC, ADLBC, ADLBH, ADNPIX, ADTTE, ADVS, ADAE, ADCM, ADMH, ADEX)
  The header and the report step follow from the shell. The sections between
  them make WORK.FINAL, one record per row of the table, in order:
    _page     the page (1 unless the output is paged); _pagelbl its heading or empty
    _ord      the row's order; _indent the label's indentation (0 = flush left)
    _rowid    the uuid of the shell row it shows (WORK._SHELL); one shell row may
              have several (a category per value); a blank row's is blank-<n>
    _kind     label | stat | blank
    rowlabel  the row's label, as text
    col1      Placebo|(N=xx)
    col2      Xanomeline Low|(N=xx)
    col3      Xanomeline High|(N=xx)
    col4      Placebo|vs.|Low Dose
    col5      Placebo|vs.|High Dose
  and set the big N of the column headers:
    &_bign1    Placebo|(N=xx)
    &_bign2    Xanomeline Low|(N=xx)
    &_bign3    Xanomeline High|(N=xx)
  /work/_lib/clinwright.sas has %ls_bign, %ls_count, %ls_stats, %ls_npct, %ls_num.
----------------------------------------------------------------------------*/
libname adam "/work/adam" access=readonly;
%include "/work/_lib/clinwright.sas";
%ls_setup;

/* The shell's rows, in order, with each column's value pattern (_xx1-_xx5). */
data work._shell;
  length _page 8 _pagelbl $200 _ord 8 _indent 8 _rowid $36 _kind $5 _var $32 rowlabel $200 _xx1 $40 _xx2 $40 _xx3 $40 _xx4 $40 _xx5 $40;
  _page = 1; _pagelbl = '';
  _ord=1; _indent=0; _rowid='f5e77b02-db7a-4d93-a9e2-a62a4fc4dd91'; _kind='stat'; _var=''; rowlabel='ANY BODY SYSTEM'; _xx1='xx (xx.x%) [xx]'; _xx2='xx (xx.x%) [xx]'; _xx3='xx (xx.x%) [xx]'; _xx4='x.xxx'; _xx5='x.xxx'; output;
  _ord=2; _indent=0; _rowid='blank-2'; _kind='blank'; _var=''; rowlabel=''; _xx1=''; _xx2=''; _xx3=''; _xx4=''; _xx5=''; output;
  _ord=3; _indent=0; _rowid='874fb9e0-866f-4cf2-a78d-41639e32f8cf'; _kind='stat'; _var=''; rowlabel='[System Organ Class]'; _xx1='xx (xx.x%) [xx]'; _xx2='xx (xx.x%) [xx]'; _xx3='xx (xx.x%) [xx]'; _xx4='x.xxx'; _xx5='x.xxx'; output;
  _ord=4; _indent=1; _rowid='51422807-260c-40a0-8d88-d8146361a8ef'; _kind='stat'; _var=''; rowlabel='[Preferred Term]'; _xx1='xx (xx.x%) [xx]'; _xx2='xx (xx.x%) [xx]'; _xx3='xx (xx.x%) [xx]'; _xx4='x.xxx'; _xx5='x.xxx'; output;
run;

/*==== 10-data ====*/
/* Made from the output's analysis: the records of ADAE with TRTEMFL = 'Y' of the subjects of ADSL with SAFFL = 'Y', by TRT01A. */
/* The population's subjects, in each column they count in. */
data work._popc;
  set adam.adsl(where=(saffl = 'Y'));
  if trt01a in ('Placebo') then do; _col = 1; output; end;
  if trt01a in ('Xanomeline Low Dose') then do; _col = 2; output; end;
  if trt01a in ('Xanomeline High Dose') then do; _col = 3; output; end;
  keep usubjid _col;
run;
data work._pop1; set adam.adsl(where=(saffl = 'Y')); keep usubjid trt01a; run;
proc sort data=work._pop1; by usubjid; run;
/* The records of ADAE with TRTEMFL = 'Y', of the population's subjects, in each column. */
proc sort data=adam.adae(keep=usubjid saffl aedecod aebodsys trtemfl where=(TRTEMFL = 'Y')) out=work._rec; by usubjid; run;
data work._an;
  merge work._rec(in=_r) work._pop1(in=_p);
  by usubjid;
  if _r and _p;
  if trt01a in ('Placebo') then do; _col = 1; output; end;
  if trt01a in ('Xanomeline Low Dose') then do; _col = 2; output; end;
  if trt01a in ('Xanomeline High Dose') then do; _col = 3; output; end;
run;
data work._cols; do _col = 1 to 5; output; end; run;
%ls_bign(data=work._popc, trt=_col, values=1|2|3|4|5|1|2|3, names=_lsn1 _lsn2 _lsn3 _lsn4 _lsn5 _bign1 _bign2 _bign3);

/* Subjects and records per column. */
proc sort data=work._an(keep=usubjid _col) out=work._u; by _col usubjid; run;
data work._c;
  set work._u;
  by _col usubjid;
  retain _n _e;
  if first._col then do; _n = 0; _e = 0; end;
  _e = _e + 1;
  if first.usubjid then _n = _n + 1;
  if last._col then output;
  keep _col _n _e;
run;
proc transpose data=work._c out=work._tn(drop=_name_) prefix=_n; id _col; var _n; run;
proc transpose data=work._c out=work._te(drop=_name_) prefix=_e; id _col; var _e; run;
data work._z; _z = 1; run;
data work._g0;
  merge work._z work._tn work._te;
  array _nn{5} _n1-_n5;
  array _ee{5} _e1-_e5;
  do _i = 1 to 5; _nn{_i} = sum(_nn{_i}, 0); _ee{_i} = sum(_ee{_i}, 0); end;
  _tot = sum(of _n1-_n5);
  drop _i _z;
run;
/* ANY BODY SYSTEM: any. */
data work._f; set work._g0; do _col = 1 to 5; output; end; run;
data work._pp4;
  set work._g0;
  array _px{5} _n1-_n5;
  %ls_pcounts(p=_p4, x=_px, cols=1 2, test=fisher);
  keep _p4;
run;
data work._f; if _n_ = 1 then set work._pp4; set work._f; run;
data work._pp5;
  set work._g0;
  array _px{5} _n1-_n5;
  %ls_pcounts(p=_p5, x=_px, cols=1 3, test=fisher);
  keep _p5;
run;
data work._f; if _n_ = 1 then set work._pp5; set work._f; run;
data work._k1;
  length _rowid $36 _label _pagelbl $200 _v $200;
  set work._f;
  array _nn{5} _n1-_n5;
  array _ee{5} _e1-_e5;
  _rowid = 'f5e77b02-db7a-4d93-a9e2-a62a4fc4dd91';
  _page = 1;
  _pagelbl = '';
  _k0 = 1;
  _k1 = 0; _k2 = 0;
  _k3 = 0; _k4 = 0;
  _label = '';
  if _col = 1 then _v = strip(ifc(missing(_nn{_col}), '-', %ls_num(_nn{_col}, 0))) || ' (' || strip(ifc(missing(ifn(input(symget(cats('_lsn', _col)), 8.) > 0, 100 * _nn{_col} / max(input(symget(cats('_lsn', _col)), 8.), 1), .)), '-', %ls_num(ifn(input(symget(cats('_lsn', _col)), 8.) > 0, 100 * _nn{_col} / max(input(symget(cats('_lsn', _col)), 8.), 1), .), 1))) || '%) [' || strip(ifc(missing(_ee{_col}), '-', %ls_num(_ee{_col}, 0))) || ']';
  else if _col = 2 then _v = strip(ifc(missing(_nn{_col}), '-', %ls_num(_nn{_col}, 0))) || ' (' || strip(ifc(missing(ifn(input(symget(cats('_lsn', _col)), 8.) > 0, 100 * _nn{_col} / max(input(symget(cats('_lsn', _col)), 8.), 1), .)), '-', %ls_num(ifn(input(symget(cats('_lsn', _col)), 8.) > 0, 100 * _nn{_col} / max(input(symget(cats('_lsn', _col)), 8.), 1), .), 1))) || '%) [' || strip(ifc(missing(_ee{_col}), '-', %ls_num(_ee{_col}, 0))) || ']';
  else if _col = 3 then _v = strip(ifc(missing(_nn{_col}), '-', %ls_num(_nn{_col}, 0))) || ' (' || strip(ifc(missing(ifn(input(symget(cats('_lsn', _col)), 8.) > 0, 100 * _nn{_col} / max(input(symget(cats('_lsn', _col)), 8.), 1), .)), '-', %ls_num(ifn(input(symget(cats('_lsn', _col)), 8.) > 0, 100 * _nn{_col} / max(input(symget(cats('_lsn', _col)), 8.), 1), .), 1))) || '%) [' || strip(ifc(missing(_ee{_col}), '-', %ls_num(_ee{_col}, 0))) || ']';
  else if _col = 4 then _v = ifc(missing(_p4), '', ifc(round(sum(_p4, 0), 0.001) < 0.001, '<0.001', ifc(round(sum(_p4, 0), 0.001) > 0.999, '>0.999', strip(put(round(sum(_p4, 0), 0.001), 32.3)))));
  else if _col = 5 then _v = ifc(missing(_p5), '', ifc(round(sum(_p5, 0), 0.001) < 0.001, '<0.001', ifc(round(sum(_p5, 0), 0.001) > 0.999, '>0.999', strip(put(round(sum(_p5, 0), 0.001), 32.3)))));
  keep _rowid _label _page _pagelbl _k0 _k1 _k2 _k3 _k4 _col _v;
run;
/* Per value of aebodsys: subjects and records per column. */
proc sort data=work._an(keep=usubjid _col aebodsys where=(not missing(aebodsys))) out=work._u; by aebodsys _col usubjid; run;
data work._c;
  set work._u;
  by aebodsys _col usubjid;
  retain _n _e;
  if first._col then do; _n = 0; _e = 0; end;
  _e = _e + 1;
  if first.usubjid then _n = _n + 1;
  if last._col then output;
  keep aebodsys _col _n _e;
run;
proc transpose data=work._c out=work._tn(drop=_name_) prefix=_n; by aebodsys; id _col; var _n; run;
proc transpose data=work._c out=work._te(drop=_name_) prefix=_e; by aebodsys; id _col; var _e; run;
data work._g1;
  merge work._tn work._te; by aebodsys;
  array _nn{5} _n1-_n5;
  array _ee{5} _e1-_e5;
  do _i = 1 to 5; _nn{_i} = sum(_nn{_i}, 0); _ee{_i} = sum(_ee{_i}, 0); end;
  _tot = sum(of _n1-_n5);
  drop _i;
run;
proc sort data=work._g1; by  aebodsys; run;
data work._g1;
  set work._g1;
  _o1 = _n_;
run;
/* [System Organ Class]: npct of AEBODSYS. */
data work._f; set work._g1; do _col = 1 to 5; output; end; run;
proc sort data=work._f; by aebodsys _col; run;
data work._pp4;
  set work._g1;
  array _px{5} _n1-_n5;
  %ls_pcounts(p=_p4, x=_px, cols=1 2, test=fisher);
  keep aebodsys _p4;
run;
proc sort data=work._pp4; by aebodsys; run;
data work._f; merge work._f(in=_in) work._pp4; by aebodsys; if _in; run;
data work._pp5;
  set work._g1;
  array _px{5} _n1-_n5;
  %ls_pcounts(p=_p5, x=_px, cols=1 3, test=fisher);
  keep aebodsys _p5;
run;
proc sort data=work._pp5; by aebodsys; run;
data work._f; merge work._f(in=_in) work._pp5; by aebodsys; if _in; run;
data work._k2;
  length _rowid $36 _label _pagelbl $200 _v $200;
  set work._f;
  array _nn{5} _n1-_n5;
  array _ee{5} _e1-_e5;
  _rowid = '874fb9e0-866f-4cf2-a78d-41639e32f8cf';
  _page = 1;
  _pagelbl = '';
  _k0 = 3;
  _k1 = _o1; _k2 = 0;
  _k3 = 0; _k4 = 0;
  _label = strip(aebodsys);
  if _col = 1 then _v = strip(ifc(missing(_nn{_col}), '-', %ls_num(_nn{_col}, 0))) || ' (' || strip(ifc(missing(ifn(input(symget(cats('_lsn', _col)), 8.) > 0, 100 * _nn{_col} / max(input(symget(cats('_lsn', _col)), 8.), 1), .)), '-', %ls_num(ifn(input(symget(cats('_lsn', _col)), 8.) > 0, 100 * _nn{_col} / max(input(symget(cats('_lsn', _col)), 8.), 1), .), 1))) || '%) [' || strip(ifc(missing(_ee{_col}), '-', %ls_num(_ee{_col}, 0))) || ']';
  else if _col = 2 then _v = strip(ifc(missing(_nn{_col}), '-', %ls_num(_nn{_col}, 0))) || ' (' || strip(ifc(missing(ifn(input(symget(cats('_lsn', _col)), 8.) > 0, 100 * _nn{_col} / max(input(symget(cats('_lsn', _col)), 8.), 1), .)), '-', %ls_num(ifn(input(symget(cats('_lsn', _col)), 8.) > 0, 100 * _nn{_col} / max(input(symget(cats('_lsn', _col)), 8.), 1), .), 1))) || '%) [' || strip(ifc(missing(_ee{_col}), '-', %ls_num(_ee{_col}, 0))) || ']';
  else if _col = 3 then _v = strip(ifc(missing(_nn{_col}), '-', %ls_num(_nn{_col}, 0))) || ' (' || strip(ifc(missing(ifn(input(symget(cats('_lsn', _col)), 8.) > 0, 100 * _nn{_col} / max(input(symget(cats('_lsn', _col)), 8.), 1), .)), '-', %ls_num(ifn(input(symget(cats('_lsn', _col)), 8.) > 0, 100 * _nn{_col} / max(input(symget(cats('_lsn', _col)), 8.), 1), .), 1))) || '%) [' || strip(ifc(missing(_ee{_col}), '-', %ls_num(_ee{_col}, 0))) || ']';
  else if _col = 4 then _v = ifc(missing(_p4), '', ifc(round(sum(_p4, 0), 0.001) < 0.001, '<0.001', ifc(round(sum(_p4, 0), 0.001) > 0.999, '>0.999', strip(put(round(sum(_p4, 0), 0.001), 32.3)))));
  else if _col = 5 then _v = ifc(missing(_p5), '', ifc(round(sum(_p5, 0), 0.001) < 0.001, '<0.001', ifc(round(sum(_p5, 0), 0.001) > 0.999, '>0.999', strip(put(round(sum(_p5, 0), 0.001), 32.3)))));
  keep _rowid _label _page _pagelbl _k0 _k1 _k2 _k3 _k4 _col _v;
run;
/* Per value of aebodsys and aedecod: subjects and records per column. */
proc sort data=work._an(keep=usubjid _col aebodsys aedecod where=(not missing(aebodsys) and not missing(aedecod))) out=work._u; by aebodsys aedecod _col usubjid; run;
data work._c;
  set work._u;
  by aebodsys aedecod _col usubjid;
  retain _n _e;
  if first._col then do; _n = 0; _e = 0; end;
  _e = _e + 1;
  if first.usubjid then _n = _n + 1;
  if last._col then output;
  keep aebodsys aedecod _col _n _e;
run;
proc transpose data=work._c out=work._tn(drop=_name_) prefix=_n; by aebodsys aedecod; id _col; var _n; run;
proc transpose data=work._c out=work._te(drop=_name_) prefix=_e; by aebodsys aedecod; id _col; var _e; run;
data work._g2;
  merge work._tn work._te; by aebodsys aedecod;
  array _nn{5} _n1-_n5;
  array _ee{5} _e1-_e5;
  do _i = 1 to 5; _nn{_i} = sum(_nn{_i}, 0); _ee{_i} = sum(_ee{_i}, 0); end;
  _tot = sum(of _n1-_n5);
  drop _i;
run;
proc sort data=work._g2; by aebodsys aedecod; run;
data work._g2;
  set work._g2;
  by aebodsys;
  retain _r;
  if first.aebodsys then _r = 0;
  _r = _r + 1;
  _o2 = _r;
  drop _r;
run;
proc sort data=work._g2; by aebodsys; run;
proc sort data=work._g1(keep=aebodsys _o1) out=work._gp; by aebodsys; run;
data work._g2; merge work._g2(in=_in) work._gp; by aebodsys; if _in; run;
/* [Preferred Term]: npct of AEDECOD. */
data work._f; set work._g2; do _col = 1 to 5; output; end; run;
proc sort data=work._f; by aebodsys aedecod _col; run;
data work._pp4;
  set work._g2;
  array _px{5} _n1-_n5;
  %ls_pcounts(p=_p4, x=_px, cols=1 2, test=fisher);
  keep aebodsys aedecod _p4;
run;
proc sort data=work._pp4; by aebodsys aedecod; run;
data work._f; merge work._f(in=_in) work._pp4; by aebodsys aedecod; if _in; run;
data work._pp5;
  set work._g2;
  array _px{5} _n1-_n5;
  %ls_pcounts(p=_p5, x=_px, cols=1 3, test=fisher);
  keep aebodsys aedecod _p5;
run;
proc sort data=work._pp5; by aebodsys aedecod; run;
data work._f; merge work._f(in=_in) work._pp5; by aebodsys aedecod; if _in; run;
data work._k3;
  length _rowid $36 _label _pagelbl $200 _v $200;
  set work._f;
  array _nn{5} _n1-_n5;
  array _ee{5} _e1-_e5;
  _rowid = '51422807-260c-40a0-8d88-d8146361a8ef';
  _page = 1;
  _pagelbl = '';
  _k0 = 3;
  _k1 = _o1; _k2 = 4;
  _k3 = _o2; _k4 = 0;
  _label = strip(aedecod);
  if _col = 1 then _v = strip(ifc(missing(_nn{_col}), '-', %ls_num(_nn{_col}, 0))) || ' (' || strip(ifc(missing(ifn(input(symget(cats('_lsn', _col)), 8.) > 0, 100 * _nn{_col} / max(input(symget(cats('_lsn', _col)), 8.), 1), .)), '-', %ls_num(ifn(input(symget(cats('_lsn', _col)), 8.) > 0, 100 * _nn{_col} / max(input(symget(cats('_lsn', _col)), 8.), 1), .), 1))) || '%) [' || strip(ifc(missing(_ee{_col}), '-', %ls_num(_ee{_col}, 0))) || ']';
  else if _col = 2 then _v = strip(ifc(missing(_nn{_col}), '-', %ls_num(_nn{_col}, 0))) || ' (' || strip(ifc(missing(ifn(input(symget(cats('_lsn', _col)), 8.) > 0, 100 * _nn{_col} / max(input(symget(cats('_lsn', _col)), 8.), 1), .)), '-', %ls_num(ifn(input(symget(cats('_lsn', _col)), 8.) > 0, 100 * _nn{_col} / max(input(symget(cats('_lsn', _col)), 8.), 1), .), 1))) || '%) [' || strip(ifc(missing(_ee{_col}), '-', %ls_num(_ee{_col}, 0))) || ']';
  else if _col = 3 then _v = strip(ifc(missing(_nn{_col}), '-', %ls_num(_nn{_col}, 0))) || ' (' || strip(ifc(missing(ifn(input(symget(cats('_lsn', _col)), 8.) > 0, 100 * _nn{_col} / max(input(symget(cats('_lsn', _col)), 8.), 1), .)), '-', %ls_num(ifn(input(symget(cats('_lsn', _col)), 8.) > 0, 100 * _nn{_col} / max(input(symget(cats('_lsn', _col)), 8.), 1), .), 1))) || '%) [' || strip(ifc(missing(_ee{_col}), '-', %ls_num(_ee{_col}, 0))) || ']';
  else if _col = 4 then _v = ifc(missing(_p4), '', ifc(round(sum(_p4, 0), 0.001) < 0.001, '<0.001', ifc(round(sum(_p4, 0), 0.001) > 0.999, '>0.999', strip(put(round(sum(_p4, 0), 0.001), 32.3)))));
  else if _col = 5 then _v = ifc(missing(_p5), '', ifc(round(sum(_p5, 0), 0.001) < 0.001, '<0.001', ifc(round(sum(_p5, 0), 0.001) > 0.999, '>0.999', strip(put(round(sum(_p5, 0), 0.001), 32.3)))));
  keep _rowid _label _page _pagelbl _k0 _k1 _k2 _k3 _k4 _col _v;
run;

data work._cells; set work._k1 work._k2 work._k3; run;
proc sort data=work._cells; by _page _pagelbl _k0 _k1 _k2 _k3 _k4 _rowid _label _col; run;
proc transpose data=work._cells out=work._wide(drop=_name_) prefix=col;
  by _page _pagelbl _k0 _k1 _k2 _k3 _k4 _rowid _label;
  id _col;
  var _v;
run;
proc sort data=work._wide; by _rowid; run;
proc sort data=work._shell(drop=_page _pagelbl) out=work._rows; by _rowid; run;
data work._inst;
  merge work._wide(in=_w) work._rows(in=_s);
  by _rowid;
  if _w and _s;
  if _label ne '' then rowlabel = _label;
run;
data work._fixed;
  set work._shell;
  if _rowid not in ('f5e77b02-db7a-4d93-a9e2-a62a4fc4dd91' '874fb9e0-866f-4cf2-a78d-41639e32f8cf' '51422807-260c-40a0-8d88-d8146361a8ef');
  _k0 = _ord; _k1 = 0; _k2 = 0; _k3 = 0; _k4 = 0;
run;
data work.final;
  length col1 col2 col3 col4 col5 $200 _pagelbl $200;
  set work._inst work._fixed;
run;
proc sort data=work.final; by _page _k0 _k1 _k2 _k3 _k4; run;
data work.final;
  set work.final;
  _ord = _n_;
  keep _page _pagelbl _ord _indent _rowid _kind rowlabel col1 col2 col3 col4 col5;
run;

/*==== 90-report ====*/
/* 90-report: from the shell; the titles, columns, headers and footnotes are not changed here. */
%ls_need(_bign1 _bign2 _bign3);
%ls_final_check(columns=_page _pagelbl _ord _indent _rowid _kind rowlabel col1 col2 col3 col4 col5);
proc sort data=work.final out=work._report; by _page _ord; run;
data work._report;
  set work._report;
  /* Two spaces per step of indentation: the label column keeps leading spaces (asis=on). */
  if _indent > 0 then rowlabel = repeat(' ', 2 * _indent - 1) || rowlabel;
run;
%let _lspaged = 0;
proc sql noprint; select count(*) into :_lspaged trimmed from work._report where _pagelbl ne ''; quit;

options orientation=landscape;
ods listing close;
ods rtf file="/work/out/t-14-5-01.rtf" style=journal;
title1 j=l "CDISCPILOT01" j=r "Page ~{thispage} of ~{lastpage}";
title2 j=c "Table 14-5.01";
title3 j=c "Incidence of Treatment Emergent Adverse Events by Treatment Group";
title4 j=c "Safety Analysis Set";
footnote1 j=l "Note: Treatment emergent events are defined as events which start on or after the start of treatment.";
footnote2 j=l "Note: Adverse events are coded using MedDRA.";
footnote3 j=l "Note: Percentages are based on the number of subjects in the safety population within each treatment group.";
footnote4 j=l "Note: P-values are based on Fisher's Exact test for the comparison of placebo versus each active treatment group.";
footnote5 j=l "Note: The column [AE] represents the total number of times an event was recorded.";
footnote6 j=l "Program: t-14-5-01.sas";
%macro _ls_report;
proc report data=work._report nowd split='|' missing style(report)={width=100%};
  column _page _pagelbl _ord _indent _kind rowlabel col1 col2 col3 ("Fisher's Exact|p-values" col4 col5);
  define _page / order order=internal noprint;
  define _pagelbl / order noprint;
  define _ord / order order=internal noprint;
  define _indent / display noprint;
  define _kind / display noprint;
  define rowlabel / display "" style(column)={cellwidth=40% asis=on} style(header)={just=l};
  define col1 / display "Placebo|(N=&_bign1.)" style(column)={cellwidth=12% just=c} style(header)={just=c};
  define col2 / display "Xanomeline Low|(N=&_bign2.)" style(column)={cellwidth=12% just=c} style(header)={just=c};
  define col3 / display "Xanomeline High|(N=&_bign3.)" style(column)={cellwidth=12% just=c} style(header)={just=c};
  define col4 / display "Placebo|vs.|Low Dose" style(column)={cellwidth=12% just=c} style(header)={just=c};
  define col5 / display "Placebo|vs.|High Dose" style(column)={cellwidth=12% just=c} style(header)={just=c};
  %if &_lspaged > 0 %then %do;
  compute before _pagelbl / style={just=l};
    line _pagelbl $200.;
  endcomp;
  %end;
  break after _page / page;
run;
%mend _ls_report;
%_ls_report;
ods rtf close;
ods listing;
%ls_final_export;

14-5.01

Program t-14-5-01.sas

Program `t-14-5-01.sas`