Post-Text Display Package

14 Tables, Figures and Graphs Referred to but not Included in the Text

Not populated in this demonstration. E3's own title, kept although this document carries no text for the displays to be excluded from. Keeping E3's number is what makes a display carry one number in the package and in the report; retitling it would have cost that for nothing.

14.1 Demographic Data

14.1.1 Subject Dispositionpost_text

t-disposition · post_text variant · study CDISCPILOT01 · data cut-off 2014-07-01

	Placebo (N=86)	Xanomeline Low Dose (N=96)	Xanomeline High Dose (N=72)	Total (N=254)
Subject Disposition
Study CDISCPILOT01 — Intent-to-Treat Analysis Set
Disposition, n (%)
Subjects randomised	86 (100.0%)	96 (100.0%)	72 (100.0%)	254 (100.0%)
Subjects treated	86 (100.0%)	96 (100.0%)	72 (100.0%)	254 (100.0%)
Completed the study	58 (67.4%)	25 (26.0%)	27 (37.5%)	110 (43.3%)
Discontinued the study	28 (32.6%)	71 (74.0%)	45 (62.5%)	144 (56.7%)
Reason for discontinuation, n (%)
Death	2 (2.3%)	1 (1.0%)	0 (0.0%)	3 (1.2%)
Other / not specified	26 (30.2%)	70 (72.9%)	45 (62.5%)	141 (55.5%)
Deaths, n (%)
Died on study	2 (2.3%)	1 (1.0%)	0 (0.0%)	3 (1.2%)
Percentages are based on the number of randomised subjects in each treatment group.
The ADSL shipped in pharmaverseadam carries no DCSREAS/DCDECOD, so the reason for discontinuation is derived: 'Death' where DTHFL = 'Y', otherwise 'Other / not specified'.
52 screen failures are excluded from every analysis dataset.
Source: adsl (pharmaverseadam). Data cut-off: 2014-07-01.
open.csr display t-disposition (post_text variant); generated from the committed ARD.

t-disposition

14.1.2 Demographic and Baseline Characteristicspost_text

t-demographics · post_text variant · study CDISCPILOT01 · data cut-off 2014-07-01

	Placebo (N=86)	Xanomeline Low Dose (N=96)	Xanomeline High Dose (N=72)	Total (N=254)
Demographic and Baseline Characteristics
Study CDISCPILOT01 — Safety Analysis Set
Age (years)
n	86	96	72	254
Mean (SD)	75.2 (8.59)	76.0 (8.11)	73.8 (7.94)	75.1 (8.25)
Median	76.0	78.0	75.5	77.0
Min, Max	52, 89	51, 88	56, 88	51, 89
Age group, n (%)
18-64	14 (16.3%)	8 (8.3%)	11 (15.3%)	33 (13.0%)
>64	72 (83.7%)	88 (91.7%)	61 (84.7%)	221 (87.0%)
Sex, n (%)
F	53 (61.6%)	55 (57.3%)	35 (48.6%)	143 (56.3%)
M	33 (38.4%)	41 (42.7%)	37 (51.4%)	111 (43.7%)
Race, n (%)
WHITE	78 (90.7%)	90 (93.8%)	62 (86.1%)	230 (90.6%)
BLACK OR AFRICAN AMERICAN	8 (9.3%)	6 (6.3%)	9 (12.5%)	23 (9.1%)
AMERICAN INDIAN OR ALASKA NATIVE	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
Ethnicity, n (%)
HISPANIC OR LATINO	3 (3.5%)	6 (6.3%)	3 (4.2%)	12 (4.7%)
NOT HISPANIC OR LATINO	83 (96.5%)	90 (93.8%)	69 (95.8%)	242 (95.3%)
Baseline weight (kg)
n	86	96	72	254
Mean (SD)	62.76 (12.77)	67.82 (14.49)	69.55 (14.35)	66.60 (14.12)
Median	60.56	66.68	68.95	66.46
Min, Max	34.02, 86.18	41.73, 106.14	44.45, 107.96	34.02, 107.96
Baseline height (cm)
Mean (SD)	162.6 (11.52)	163.7 (10.30)	165.9 (10.28)	163.9 (10.76)
Min, Max	137.2, 185.4	135.9, 195.6	146.1, 190.5	135.9, 195.6
Baseline BMI (kg/m2)
Mean (SD)	23.63 (3.67)	25.22 (4.39)	25.17 (3.97)	24.67 (4.09)
Min, Max	15.06, 33.25	15.31, 40.17	13.67, 34.57	13.67, 40.17
Percentages are based on the number of subjects in the safety analysis set for each treatment group.
Baseline weight, height and body mass index are the ADVS records flagged ABLFL = 'Y'.
Source: adsl (pharmaverseadam), baseline vital signs from advs. Data cut-off: 2014-07-01.
open.csr display t-demographics (post_text variant); generated from the committed ARD.

t-demographics

14.2 Efficacy Data

Not populated in this demonstration. Declared and left empty. No efficacy analysis dataset exists for CDISCPILOT01 in pharmaverseadam (design decision D12) and the reference report for the same study carries thirteen efficacy tables. A package that dropped the heading would look finished and tell the reviewer less.

14.3 Safety Data

Not populated in this demonstration.

14.3.1 Displays of Adverse Events

14.3.1.1 Extent of Exposure to Study Drugpost_text

t-exposure · post_text variant · study CDISCPILOT01 · data cut-off 2014-07-01

	Placebo (N=86)	Xanomeline Low Dose (N=96)	Xanomeline High Dose (N=72)	Total (N=254)
Extent of Exposure to Study Drug
Study CDISCPILOT01 — Safety Analysis Set
Duration of exposure (days)
n	86	96	72	254
Mean (SD)	147.8 (62.13)	85.9 (70.66)	112.2 (65.52)	114.3 (71.17)
Median	182.0	62.5	96.5	130.5
Q1, Q3	130.0, 183.0	21.5, 180.5	53.5, 183.0	43.0, 183.0
Min, Max	0, 210	0, 212	15, 200	0, 212
Total dose administered (mg)
Mean (SD)	0.0 (0.0)	4638.9 (3815.6)	8341.5 (5182.9)	4117.8 (4893.8)
Median	0.0	3375.0	7114.5	2025.0
Min, Max	0, 0	0, 11448	810, 15417	0, 15417
Average daily dose (mg)
Mean (SD)	0.00 (0.00)	54.00 (0.00)	72.89 (9.68)	41.18 (30.85)
Median	0.00	54.00	75.90	54.00
Overall dose intensity (%)
n	0	95	72	167
Mean (SD)		100.0 (0.00)	135.0 (17.92)	115.1 (20.96)
Median		100.0	140.6	100.0
Cumulative exposure, n (%)
≥ 1 day	85 (98.8%)	95 (99.0%)	72 (100.0%)	252 (99.2%)
≥ 30 days	78 (90.7%)	65 (67.7%)	67 (93.1%)	210 (82.7%)
≥ 90 days	67 (77.9%)	40 (41.7%)	38 (52.8%)	145 (57.1%)
≥ 180 days	55 (64.0%)	25 (26.0%)	26 (36.1%)	106 (41.7%)
Duration, total dose, average daily dose and dose intensity are the overall-study ADEX parameters TDURD, TDOSE, AVDDSE and TDOSINT respectively.
Exposure categories are cumulative: a subject exposed for 200 days is counted in every category up to 180 days.
Q1 and Q3 are type-2 (SAS-compatible) quantiles, as computed by {cards}; they differ from R’s default type-7 quantiles.
Percentages are based on the number of subjects in the safety analysis set for each treatment group.
Placebo subjects have no ADEX dose-intensity (TDOSINT) records because planned placebo dose is zero; the dose-intensity rows are therefore empty for that column.
Source: adex, adsl (pharmaverseadam). Data cut-off: 2014-07-01.
open.csr display t-exposure (post_text variant); generated from the committed ARD.

t-exposure

14.3.1.2 Overview of Treatment-Emergent Adverse Eventspost_text

t-ae-overview · post_text variant · study CDISCPILOT01 · data cut-off 2014-07-01

	Placebo (N=86)	Xanomeline Low Dose (N=96)	Xanomeline High Dose (N=72)	Total (N=254)
Overview of Treatment-Emergent Adverse Events
Study CDISCPILOT01 — Safety Analysis Set
Adverse events
Number of events	281	427	414	1122
Subjects with ≥1 adverse event	65 (75.6%)	84 (87.5%)	68 (94.4%)	217 (85.4%)
Subjects with a serious adverse event	0 (0.0%)	2 (2.1%)	1 (1.4%)	3 (1.2%)
Subjects with a fatal adverse event	2 (2.3%)	1 (1.0%)	0 (0.0%)	3 (1.2%)
Subjects with a related adverse event	43 (50.0%)	77 (80.2%)	64 (88.9%)	184 (72.4%)
Subjects by severity, n (%)
Mild	58 (67.4%)	64 (66.7%)	64 (88.9%)	186 (73.2%)
Moderate	25 (29.1%)	58 (60.4%)	46 (63.9%)	129 (50.8%)
Severe	5 (5.8%)	16 (16.7%)	8 (11.1%)	29 (11.4%)
A treatment-emergent adverse event is an event with TRTEMFL = 'Y'.
Percentages are based on the number of subjects in the safety analysis set for each treatment group.
Subjects reporting more than one event are counted once in each row they qualify for; severity rows count subjects with at least one event of that severity and therefore do not sum to the number of subjects with any event.
Source: adae, adsl (pharmaverseadam). Data cut-off: 2014-07-01.
open.csr display t-ae-overview (post_text variant); generated from the committed ARD.

t-ae-overview

14.3.1.3 Treatment-Emergent Adverse Events by System Organ Class and Preferred Termpost_text

t-ae-common · post_text variant · study CDISCPILOT01 · data cut-off 2014-07-01

	Placebo (N=86)	Xanomeline Low Dose (N=96)	Xanomeline High Dose (N=72)	Total (N=254)
Treatment-Emergent Adverse Events by System Organ Class and Preferred Term
Study CDISCPILOT01 — Safety Analysis Set
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	21 (24.4%)	51 (53.1%)	36 (50.0%)	108 (42.5%)
APPLICATION SITE PRURITUS	6 (7.0%)	23 (24.0%)	21 (29.2%)	50 (19.7%)
APPLICATION SITE ERYTHEMA	3 (3.5%)	13 (13.5%)	14 (19.4%)	30 (11.8%)
APPLICATION SITE DERMATITIS	5 (5.8%)	9 (9.4%)	7 (9.7%)	21 (8.3%)
APPLICATION SITE IRRITATION	3 (3.5%)	9 (9.4%)	9 (12.5%)	21 (8.3%)
APPLICATION SITE VESICLES	1 (1.2%)	5 (5.2%)	5 (6.9%)	11 (4.3%)
FATIGUE	1 (1.2%)	5 (5.2%)	5 (6.9%)	11 (4.3%)
OEDEMA PERIPHERAL	2 (2.3%)	1 (1.0%)	2 (2.8%)	5 (2.0%)
APPLICATION SITE SWELLING	0 (0.0%)	1 (1.0%)	2 (2.8%)	3 (1.2%)
APPLICATION SITE URTICARIA	0 (0.0%)	2 (2.1%)	1 (1.4%)	3 (1.2%)
CHILLS	1 (1.2%)	1 (1.0%)	1 (1.4%)	3 (1.2%)
MALAISE	0 (0.0%)	1 (1.0%)	2 (2.8%)	3 (1.2%)
PYREXIA	2 (2.3%)	1 (1.0%)	0 (0.0%)	3 (1.2%)
APPLICATION SITE PAIN	0 (0.0%)	0 (0.0%)	2 (2.8%)	2 (0.8%)
APPLICATION SITE PERSPIRATION	0 (0.0%)	0 (0.0%)	2 (2.8%)	2 (0.8%)
APPLICATION SITE REACTION	1 (1.2%)	0 (0.0%)	1 (1.4%)	2 (0.8%)
ASTHENIA	1 (1.2%)	1 (1.0%)	0 (0.0%)	2 (0.8%)
CHEST DISCOMFORT	0 (0.0%)	1 (1.0%)	1 (1.4%)	2 (0.8%)
CHEST PAIN	0 (0.0%)	0 (0.0%)	2 (2.8%)	2 (0.8%)
OEDEMA	0 (0.0%)	2 (2.1%)	0 (0.0%)	2 (0.8%)
PAIN	0 (0.0%)	1 (1.0%)	1 (1.4%)	2 (0.8%)
APPLICATION SITE BLEEDING	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
APPLICATION SITE DESQUAMATION	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
APPLICATION SITE DISCHARGE	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
APPLICATION SITE DISCOLOURATION	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
APPLICATION SITE INDURATION	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
APPLICATION SITE WARMTH	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
FEELING ABNORMAL	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
FEELING COLD	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
INFLAMMATION	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
SECRETION DISCHARGE	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
SUDDEN DEATH	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
SWELLING	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
ULCER	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
SKIN AND SUBCUTANEOUS TISSUE DISORDERS	20 (23.3%)	39 (40.6%)	39 (54.2%)	98 (38.6%)
PRURITUS	8 (9.3%)	21 (21.9%)	25 (34.7%)	54 (21.3%)
ERYTHEMA	8 (9.3%)	14 (14.6%)	14 (19.4%)	36 (14.2%)
RASH	5 (5.8%)	13 (13.5%)	8 (11.1%)	26 (10.2%)
HYPERHIDROSIS	2 (2.3%)	4 (4.2%)	8 (11.1%)	14 (5.5%)
SKIN IRRITATION	3 (3.5%)	6 (6.3%)	5 (6.9%)	14 (5.5%)
BLISTER	0 (0.0%)	5 (5.2%)	1 (1.4%)	6 (2.4%)
RASH PRURITIC	0 (0.0%)	1 (1.0%)	2 (2.8%)	3 (1.2%)
PRURITUS GENERALISED	0 (0.0%)	1 (1.0%)	1 (1.4%)	2 (0.8%)
URTICARIA	0 (0.0%)	1 (1.0%)	1 (1.4%)	2 (0.8%)
ACTINIC KERATOSIS	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
ALOPECIA	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
COLD SWEAT	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
DERMATITIS CONTACT	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
DRUG ERUPTION	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
RASH ERYTHEMATOUS	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
RASH MACULO-PAPULAR	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
SKIN EXFOLIATION	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
SKIN ODOUR ABNORMAL	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
SKIN ULCER	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
NERVOUS SYSTEM DISORDERS	8 (9.3%)	22 (22.9%)	23 (31.9%)	53 (20.9%)
DIZZINESS	2 (2.3%)	9 (9.4%)	10 (13.9%)	21 (8.3%)
HEADACHE	3 (3.5%)	3 (3.1%)	5 (6.9%)	11 (4.3%)
SYNCOPE	0 (0.0%)	5 (5.2%)	2 (2.8%)	7 (2.8%)
SOMNOLENCE	2 (2.3%)	3 (3.1%)	1 (1.4%)	6 (2.4%)
TRANSIENT ISCHAEMIC ATTACK	0 (0.0%)	2 (2.1%)	1 (1.4%)	3 (1.2%)
BURNING SENSATION	0 (0.0%)	0 (0.0%)	2 (2.8%)	2 (0.8%)
LETHARGY	0 (0.0%)	1 (1.0%)	1 (1.4%)	2 (0.8%)
AMNESIA	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
BALANCE DISORDER	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
COGNITIVE DISORDER	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
COMPLEX PARTIAL SEIZURES	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
COORDINATION ABNORMAL	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
HEMIANOPIA HOMONYMOUS	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
HYPERSOMNIA	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
PARAESTHESIA	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
PARAESTHESIA ORAL	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
PARKINSON'S DISEASE	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
PAROSMIA	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
PARTIAL SEIZURES WITH SECONDARY GENERALISATION	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
PSYCHOMOTOR HYPERACTIVITY	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
STUPOR	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
SYNCOPE VASOVAGAL	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
GASTROINTESTINAL DISORDERS	17 (19.8%)	15 (15.6%)	19 (26.4%)	51 (20.1%)
DIARRHOEA	9 (10.5%)	5 (5.2%)	3 (4.2%)	17 (6.7%)
VOMITING	3 (3.5%)	4 (4.2%)	6 (8.3%)	13 (5.1%)
NAUSEA	3 (3.5%)	3 (3.1%)	6 (8.3%)	12 (4.7%)
ABDOMINAL PAIN	1 (1.2%)	3 (3.1%)	1 (1.4%)	5 (2.0%)
SALIVARY HYPERSECRETION	0 (0.0%)	0 (0.0%)	4 (5.6%)	4 (1.6%)
DYSPEPSIA	1 (1.2%)	1 (1.0%)	0 (0.0%)	2 (0.8%)
ABDOMINAL DISCOMFORT	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
CONSTIPATION	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
DYSPHAGIA	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
FLATULENCE	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
GASTROINTESTINAL HAEMORRHAGE	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
GASTROOESOPHAGEAL REFLUX DISEASE	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
GLOSSITIS	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
HIATUS HERNIA	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
RECTAL HAEMORRHAGE	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
STOMACH DISCOMFORT	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
CARDIAC DISORDERS	12 (14.0%)	14 (14.6%)	14 (19.4%)	40 (15.7%)
SINUS BRADYCARDIA	2 (2.3%)	7 (7.3%)	8 (11.1%)	17 (6.7%)
MYOCARDIAL INFARCTION	4 (4.7%)	2 (2.1%)	4 (5.6%)	10 (3.9%)
ATRIAL FIBRILLATION	1 (1.2%)	2 (2.1%)	2 (2.8%)	5 (2.0%)
SUPRAVENTRICULAR EXTRASYSTOLES	1 (1.2%)	1 (1.0%)	1 (1.4%)	3 (1.2%)
VENTRICULAR EXTRASYSTOLES	0 (0.0%)	2 (2.1%)	1 (1.4%)	3 (1.2%)
ATRIAL FLUTTER	0 (0.0%)	1 (1.0%)	1 (1.4%)	2 (0.8%)
ATRIOVENTRICULAR BLOCK FIRST DEGREE	1 (1.2%)	1 (1.0%)	0 (0.0%)	2 (0.8%)
BUNDLE BRANCH BLOCK RIGHT	1 (1.2%)	1 (1.0%)	0 (0.0%)	2 (0.8%)
PALPITATIONS	0 (0.0%)	2 (2.1%)	0 (0.0%)	2 (0.8%)
ATRIAL HYPERTROPHY	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
ATRIOVENTRICULAR BLOCK SECOND DEGREE	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
BRADYCARDIA	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
BUNDLE BRANCH BLOCK LEFT	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
CARDIAC DISORDER	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
CARDIAC FAILURE CONGESTIVE	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
SINUS ARRHYTHMIA	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
SUPRAVENTRICULAR TACHYCARDIA	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
TACHYCARDIA	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
VENTRICULAR HYPERTROPHY	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
WOLFF-PARKINSON-WHITE SYNDROME	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
INFECTIONS AND INFESTATIONS	16 (18.6%)	9 (9.4%)	13 (18.1%)	38 (15.0%)
NASOPHARYNGITIS	2 (2.3%)	4 (4.2%)	6 (8.3%)	12 (4.7%)
UPPER RESPIRATORY TRACT INFECTION	6 (7.0%)	1 (1.0%)	3 (4.2%)	10 (3.9%)
INFLUENZA	1 (1.2%)	1 (1.0%)	1 (1.4%)	3 (1.2%)
URINARY TRACT INFECTION	2 (2.3%)	0 (0.0%)	1 (1.4%)	3 (1.2%)
CYSTITIS	1 (1.2%)	0 (0.0%)	1 (1.4%)	2 (0.8%)
EAR INFECTION	2 (2.3%)	0 (0.0%)	0 (0.0%)	2 (0.8%)
BRONCHITIS	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
CELLULITIS	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
CERVICITIS	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
GASTROENTERITIS VIRAL	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
HORDEOLUM	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
LOCALISED INFECTION	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
LOWER RESPIRATORY TRACT INFECTION	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
PNEUMONIA	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
RHINITIS	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
VAGINAL MYCOSIS	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
VIRAL INFECTION	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
PSYCHIATRIC DISORDERS	10 (11.6%)	11 (11.5%)	7 (9.7%)	28 (11.0%)
CONFUSIONAL STATE	2 (2.3%)	3 (3.1%)	1 (1.4%)	6 (2.4%)
AGITATION	2 (2.3%)	3 (3.1%)	0 (0.0%)	5 (2.0%)
INSOMNIA	2 (2.3%)	0 (0.0%)	2 (2.8%)	4 (1.6%)
ANXIETY	0 (0.0%)	3 (3.1%)	0 (0.0%)	3 (1.2%)
DELUSION	1 (1.2%)	0 (0.0%)	1 (1.4%)	2 (0.8%)
IRRITABILITY	1 (1.2%)	1 (1.0%)	0 (0.0%)	2 (0.8%)
COMPLETED SUICIDE	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
DELIRIUM	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
DEPRESSED MOOD	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
DISORIENTATION	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
HALLUCINATION	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
HALLUCINATION, VISUAL	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
LIBIDO DECREASED	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
LISTLESS	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
NIGHTMARE	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
RESTLESSNESS	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	8 (9.3%)	9 (9.4%)	10 (13.9%)	27 (10.6%)
COUGH	1 (1.2%)	5 (5.2%)	5 (6.9%)	11 (4.3%)
NASAL CONGESTION	3 (3.5%)	1 (1.0%)	3 (4.2%)	7 (2.8%)
DYSPNOEA	1 (1.2%)	1 (1.0%)	1 (1.4%)	3 (1.2%)
EPISTAXIS	0 (0.0%)	1 (1.0%)	2 (2.8%)	3 (1.2%)
PHARYNGOLARYNGEAL PAIN	0 (0.0%)	1 (1.0%)	1 (1.4%)	2 (0.8%)
RHINORRHOEA	0 (0.0%)	1 (1.0%)	1 (1.4%)	2 (0.8%)
ALLERGIC GRANULOMATOUS ANGIITIS	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
DYSPHONIA	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
EMPHYSEMA	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
HAEMOPTYSIS	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
PHARYNGEAL ERYTHEMA	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
POSTNASAL DRIP	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
PRODUCTIVE COUGH	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
RALES	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
RESPIRATORY TRACT CONGESTION	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
INVESTIGATIONS	10 (11.6%)	7 (7.3%)	5 (6.9%)	22 (8.7%)
ELECTROCARDIOGRAM ST SEGMENT DEPRESSION	4 (4.7%)	1 (1.0%)	0 (0.0%)	5 (2.0%)
ELECTROCARDIOGRAM T WAVE INVERSION	2 (2.3%)	1 (1.0%)	1 (1.4%)	4 (1.6%)
BLOOD GLUCOSE INCREASED	0 (0.0%)	1 (1.0%)	1 (1.4%)	2 (0.8%)
ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED	1 (1.2%)	1 (1.0%)	0 (0.0%)	2 (0.8%)
BIOPSY	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
BIOPSY PROSTATE	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
BLOOD ALKALINE PHOSPHATASE INCREASED	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
BLOOD CHOLESTEROL INCREASED	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
BLOOD CREATINE PHOSPHOKINASE INCREASED	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
BLOOD URINE PRESENT	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
BODY TEMPERATURE INCREASED	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
CYSTOSCOPY	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
HEART RATE INCREASED	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
HEART RATE IRREGULAR	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
NASAL MUCOSA BIOPSY	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
WEIGHT DECREASED	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	4 (4.7%)	7 (7.3%)	7 (9.7%)	18 (7.1%)
BACK PAIN	1 (1.2%)	1 (1.0%)	3 (4.2%)	5 (2.0%)
ARTHRALGIA	1 (1.2%)	2 (2.1%)	1 (1.4%)	4 (1.6%)
SHOULDER PAIN	1 (1.2%)	2 (2.1%)	0 (0.0%)	3 (1.2%)
MUSCLE SPASMS	0 (0.0%)	1 (1.0%)	1 (1.4%)	2 (0.8%)
ARTHRITIS	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
FLANK PAIN	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
MUSCULAR WEAKNESS	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
MYALGIA	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
PAIN IN EXTREMITY	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
INJURY, POISONING AND PROCEDURAL COMPLICATIONS	4 (4.7%)	5 (5.2%)	5 (6.9%)	14 (5.5%)
CONTUSION	1 (1.2%)	1 (1.0%)	2 (2.8%)	4 (1.6%)
EXCORIATION	2 (2.3%)	1 (1.0%)	1 (1.4%)	4 (1.6%)
FALL	1 (1.2%)	2 (2.1%)	1 (1.4%)	4 (1.6%)
HIP FRACTURE	1 (1.2%)	0 (0.0%)	2 (2.8%)	3 (1.2%)
SKIN LACERATION	1 (1.2%)	2 (2.1%)	0 (0.0%)	3 (1.2%)
FACIAL BONES FRACTURE	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
JOINT DISLOCATION	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
WOUND	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
RENAL AND URINARY DISORDERS	4 (4.7%)	3 (3.1%)	3 (4.2%)	10 (3.9%)
MICTURITION URGENCY	1 (1.2%)	1 (1.0%)	1 (1.4%)	3 (1.2%)
DYSURIA	1 (1.2%)	1 (1.0%)	0 (0.0%)	2 (0.8%)
NEPHROLITHIASIS	1 (1.2%)	0 (0.0%)	1 (1.4%)	2 (0.8%)
CALCULUS URETHRAL	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
INCONTINENCE	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
POLLAKIURIA	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
METABOLISM AND NUTRITION DISORDERS	6 (7.0%)	1 (1.0%)	2 (2.8%)	9 (3.5%)
DECREASED APPETITE	1 (1.2%)	0 (0.0%)	1 (1.4%)	2 (0.8%)
FOOD CRAVING	1 (1.2%)	1 (1.0%)	0 (0.0%)	2 (0.8%)
INCREASED APPETITE	1 (1.2%)	0 (0.0%)	1 (1.4%)	2 (0.8%)
DEHYDRATION	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
DIABETES MELLITUS	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
HYPONATRAEMIA	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
VASCULAR DISORDERS	3 (3.5%)	3 (3.1%)	1 (1.4%)	7 (2.8%)
HYPOTENSION	2 (2.3%)	1 (1.0%)	0 (0.0%)	3 (1.2%)
HYPERTENSION	1 (1.2%)	1 (1.0%)	0 (0.0%)	2 (0.8%)
HOT FLUSH	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
ORTHOSTATIC HYPOTENSION	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
WOUND HAEMORRHAGE	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
EYE DISORDERS	2 (2.3%)	2 (2.1%)	1 (1.4%)	5 (2.0%)
VISION BLURRED	0 (0.0%)	1 (1.0%)	1 (1.4%)	2 (0.8%)
CONJUNCTIVAL HAEMORRHAGE	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
CONJUNCTIVITIS	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
EYE ALLERGY	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
EYE PRURITUS	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
EYE SWELLING	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
SURGICAL AND MEDICAL PROCEDURES	2 (2.3%)	1 (1.0%)	2 (2.8%)	5 (2.0%)
CATARACT OPERATION	1 (1.2%)	1 (1.0%)	0 (0.0%)	2 (0.8%)
ACROCHORDON EXCISION	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
EYE LASER SURGERY	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
SKIN LESION EXCISION	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
EAR AND LABYRINTH DISORDERS	1 (1.2%)	2 (2.1%)	1 (1.4%)	4 (1.6%)
VERTIGO	0 (0.0%)	1 (1.0%)	1 (1.4%)	2 (0.8%)
CERUMEN IMPACTION	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
EAR PAIN	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
CONGENITAL, FAMILIAL AND GENETIC DISORDERS	0 (0.0%)	1 (1.0%)	2 (2.8%)	3 (1.2%)
VENTRICULAR SEPTAL DEFECT	0 (0.0%)	1 (1.0%)	2 (2.8%)	3 (1.2%)
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)	0 (0.0%)	2 (2.1%)	1 (1.4%)	3 (1.2%)
COLON CANCER	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
MALIGNANT FIBROUS HISTIOCYTOMA	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
PROSTATE CANCER	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
REPRODUCTIVE SYSTEM AND BREAST DISORDERS	2 (2.3%)	0 (0.0%)	1 (1.4%)	3 (1.2%)
BENIGN PROSTATIC HYPERPLASIA	1 (1.2%)	0 (0.0%)	1 (1.4%)	2 (0.8%)
PELVIC PAIN	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
HEPATOBILIARY DISORDERS	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
HYPERBILIRUBINAEMIA	1 (1.2%)	0 (0.0%)	0 (0.0%)	1 (0.4%)
IMMUNE SYSTEM DISORDERS	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
HYPERSENSITIVITY	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.4%)
SOCIAL CIRCUMSTANCES	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
ALCOHOL USE	0 (0.0%)	0 (0.0%)	1 (1.4%)	1 (0.4%)
Subjects are counted once per system organ class and once per preferred term, regardless of how many events they reported.
Percentages are based on the number of subjects in the safety analysis set for each treatment group.
System organ classes and preferred terms are sorted by descending subject count.
The Total column pools all treatment groups; the 5% threshold applied to the in-text variant is evaluated on the treatment columns only, never on Total.
Source: adae, adsl (pharmaverseadam). Data cut-off: 2014-07-01.
open.csr display t-ae-common (post_text variant); generated from the committed ARD.

t-ae-common

14.3.2 Listings of Deaths, Other Serious and Significant Adverse Events

14.3.2.1 Listing of Serious Adverse Eventspost_text

l-ae-serious · post_text variant · study CDISCPILOT01 · data cut-off 2014-07-01

	Subject	Treatment	Age	Sex	System organ class	Preferred term	Severity	Relationship	Start day	End day	Outcome
Listing of Serious Adverse Events
Study CDISCPILOT01 — Safety Analysis Set
1	01-709-1424	Xanomeline Low Dose	77	M	NERVOUS SYSTEM DISORDERS	SYNCOPE	MODERATE	POSSIBLE	5	5	RECOVERED/RESOLVED
2	01-718-1170	Xanomeline Low Dose	80	F	NERVOUS SYSTEM DISORDERS	SYNCOPE	SEVERE	PROBABLE	27	28	RECOVERED/RESOLVED
3	01-718-1371	Xanomeline High Dose	69	F	NERVOUS SYSTEM DISORDERS	PARTIAL SEIZURES WITH SECONDARY GENERALISATION	SEVERE	NONE	38	41	RECOVERED/RESOLVED
One row per serious adverse event record (AESER = 'Y').
Study day is relative to the first dose of study drug.
Source: adae (pharmaverseadam). Data cut-off: 2014-07-01.
open.csr display l-ae-serious (post_text variant); generated from the committed ARD.

l-ae-serious

14.3.4 Abnormal Laboratory Value Listing (Each Patient)

Not populated in this demonstration. Declared and left empty: the reference report for this study carries six laboratory displays and open.csr produces none of them yet. E3 Section 14.3.3 is omitted rather than left empty, because it is narrative and this document carries none.

14.3.5 Displays of Vital Signs, Weight and Concomitant Medications

14.3.5.1 Summary of Vital Signs at Baseline and End of Treatmentpost_text

t-vitals · post_text variant · study CDISCPILOT01 · data cut-off 2014-07-01

	Placebo (N=86)	Xanomeline Low Dose (N=84)	Xanomeline High Dose (N=84)
Summary of Vital Signs at Baseline and End of Treatment
Study CDISCPILOT01 — Safety Analysis Set
Systolic Blood Pressure (mmHg)
After lying down for 5 minutes
Baseline
n	85	84	84
Mean (SD)	138.6 (16.75)	138.8 (16.55)	140.1 (17.82)
Median	140.0	138.0	141.0
Min, Max	90.0, 180.0	100.0, 178.0	100.0, 188.0
Week 24
n	59	27	30
Mean (SD)	135.8 (17.30)	134.1 (16.74)	132.2 (18.18)
Median	131.0	136.0	130.0
Min, Max	100.0, 180.0	100.0, 173.0	101.0, 178.0
End of treatment
n	84	84	82
Mean (SD)	136.7 (18.30)	135.7 (17.17)	134.0 (17.86)
Median	134.0	134.0	130.0
Min, Max	100.0, 180.0	100.0, 190.0	101.0, 178.0
After standing for 1 minute
Baseline
n	85	84	84
Mean (SD)	135.3 (17.89)	135.6 (18.04)	137.3 (19.71)
Median	134.0	136.0	138.0
Min, Max	90.0, 180.0	100.0, 186.0	100.0, 194.0
Week 24
n	59	27	30
Mean (SD)	133.5 (19.23)	131.0 (17.82)	130.4 (20.83)
Median	130.0	130.0	128.0
Min, Max	90.0, 199.0	92.0, 168.0	96.0, 198.0
End of treatment
n	84	84	82
Mean (SD)	133.9 (18.68)	132.8 (17.53)	130.4 (20.37)
Median	130.5	130.0	128.0
Min, Max	90.0, 199.0	92.0, 180.0	90.0, 198.0
After standing for 3 minutes
Baseline
n	85	84	84
Mean (SD)	136.5 (18.77)	136.4 (18.11)	138.8 (18.75)
Median	136.0	134.5	138.0
Min, Max	80.0, 184.0	104.0, 182.0	100.0, 186.0
Week 24
n	59	27	30
Mean (SD)	134.8 (17.35)	131.0 (17.92)	129.2 (16.95)
Median	131.0	130.0	126.0
Min, Max	100.0, 190.0	100.0, 168.0	90.0, 172.0
End of treatment
n	84	83	81
Mean (SD)	134.1 (18.01)	133.1 (17.80)	130.4 (17.77)
Median	130.0	130.0	130.0
Min, Max	90.0, 190.0	98.0, 200.0	88.0, 184.0
Diastolic Blood Pressure (mmHg)
After lying down for 5 minutes
Baseline
n	85	84	84
Mean (SD)	75.7 (11.09)	76.3 (9.77)	77.2 (9.80)
Median	76.0	76.0	78.0
Min, Max	40.0, 99.0	57.0, 100.0	51.0, 98.0
Week 24
n	59	27	30
Mean (SD)	72.9 (11.32)	76.1 (9.14)	73.9 (9.23)
Median	74.0	76.0	74.0
Min, Max	44.0, 109.0	60.0, 90.0	60.0, 92.0
End of treatment
n	84	84	82
Mean (SD)	74.5 (11.11)	74.3 (8.88)	74.1 (9.27)
Median	76.0	74.0	74.0
Min, Max	44.0, 109.0	45.0, 90.0	56.0, 94.0
After standing for 1 minute
Baseline
n	85	84	84
Mean (SD)	77.9 (10.63)	76.2 (10.14)	78.1 (10.77)
Median	78.0	78.0	78.0
Min, Max	51.0, 104.0	54.0, 98.0	56.0, 108.0
Week 24
n	59	27	30
Mean (SD)	74.2 (12.89)	76.3 (10.28)	74.9 (11.00)
Median	74.0	78.0	76.0
Min, Max	45.0, 117.0	60.0, 98.0	50.0, 97.0
End of treatment
n	84	84	82
Mean (SD)	74.9 (12.16)	75.0 (9.34)	75.9 (11.77)
Median	76.0	75.0	76.5
Min, Max	45.0, 117.0	51.0, 98.0	48.0, 112.0
After standing for 3 minutes
Baseline
n	85	84	84
Mean (SD)	77.7 (11.00)	76.6 (10.93)	79.6 (10.19)
Median	78.0	76.0	80.0
Min, Max	46.0, 110.0	48.0, 108.0	51.0, 104.0
Week 24
n	59	27	30
Mean (SD)	74.3 (11.38)	76.2 (10.18)	76.0 (10.63)
Median	74.0	76.0	78.5
Min, Max	51.0, 110.0	57.0, 98.0	50.0, 98.0
End of treatment
n	84	83	81
Mean (SD)	75.0 (11.19)	74.9 (9.66)	76.8 (11.71)
Median	74.5	74.0	78.0
Min, Max	51.0, 110.0	57.0, 102.0	50.0, 118.0
Pulse (beats/min)
After lying down for 5 minutes
Baseline
n	85	84	84
Mean (SD)	70.4 (10.46)	68.8 (9.52)	70.1 (9.27)
Median	70.0	68.0	68.0
Min, Max	51.0, 100.0	50.0, 88.0	52.0, 98.0
Week 24
n	59	27	30
Mean (SD)	69.1 (9.46)	68.1 (9.28)	69.3 (11.88)
Median	68.0	68.0	68.0
Min, Max	50.0, 92.0	52.0, 90.0	47.0, 96.0
End of treatment
n	84	84	82
Mean (SD)	69.3 (9.42)	67.8 (10.55)	68.1 (11.27)
Median	68.5	68.0	68.0
Min, Max	50.0, 92.0	48.0, 100.0	47.0, 100.0
After standing for 1 minute
Baseline
n	85	84	84
Mean (SD)	75.5 (12.68)	73.5 (10.59)	75.0 (10.89)
Median	76.0	72.0	72.0
Min, Max	56.0, 133.0	53.0, 100.0	56.0, 104.0
Week 24
n	59	27	30
Mean (SD)	72.8 (8.98)	72.1 (9.53)	73.4 (11.93)
Median	74.0	74.0	72.0
Min, Max	52.0, 88.0	52.0, 88.0	54.0, 98.0
End of treatment
n	84	84	82
Mean (SD)	73.5 (9.09)	73.0 (10.84)	72.6 (11.11)
Median	74.0	73.0	71.0
Min, Max	52.0, 96.0	51.0, 104.0	52.0, 100.0
After standing for 3 minutes
Baseline
n	85	84	84
Mean (SD)	74.6 (11.94)	72.3 (10.99)	74.0 (10.76)
Median	74.0	70.0	72.0
Min, Max	54.0, 134.0	51.0, 104.0	52.0, 100.0
Week 24
n	59	27	30
Mean (SD)	72.8 (8.73)	70.7 (10.78)	72.4 (11.92)
Median	74.0	72.0	71.5
Min, Max	56.0, 88.0	52.0, 96.0	54.0, 96.0
End of treatment
n	84	83	81
Mean (SD)	73.4 (9.08)	71.6 (10.42)	71.8 (10.76)
Median	74.0	72.0	70.0
Min, Max	56.0, 98.0	52.0, 97.0	54.0, 106.0
Treatment groups are PLANNED treatment (TRT01P). Twelve subjects in this study received a treatment other than the one they were randomised to; grouping by actual treatment (TRT01A) would give column sizes of 86, 96 and 72.
Blood pressure and pulse are measured in three positions and each position is summarised as its own series: a subject's baseline after standing for three minutes is not the baseline for their supine measurement.
End of treatment is the last observed measurement of that parameter in that position, at a planned visit after Week 0 up to and including Week 24. Unscheduled visits, the Week 26 follow-up visit and records derived by averaging or carry-forward are never selected.
n is the number of subjects contributing a measurement; N in the column header is the number of subjects in the safety analysis set.
Source: advs, adsl (pharmaverseadam). Data cut-off: 2014-07-01.
open.csr display t-vitals (post_text variant); generated from the committed ARD.

t-vitals

14.3.5.2 Summary of Vital Signs Change from Baseline at End of Treatmentpost_text

t-vitals-change · post_text variant · study CDISCPILOT01 · data cut-off 2014-07-01

	Placebo (N=86)	Xanomeline Low Dose (N=84)	Xanomeline High Dose (N=84)
Summary of Vital Signs Change from Baseline at End of Treatment
Study CDISCPILOT01 — Safety Analysis Set
Systolic Blood Pressure (mmHg)
After lying down for 5 minutes
Week 24
n	58	27	30
Mean (SD)	-2.1 (14.73)	-0.3 (17.19)	-5.6 (17.18)
Median	-4.0	2.0	-7.0
Min, Max	-28.0, 50.0	-48.0, 30.0	-36.0, 26.0
End of treatment
n	83	84	82
Mean (SD)	-2.0 (16.76)	-3.1 (16.57)	-5.8 (14.48)
Median	-4.0	-2.0	-8.0
Min, Max	-32.0, 50.0	-48.0, 34.0	-36.0, 29.0
After standing for 1 minute
Week 24
n	58	27	30
Mean (SD)	-1.7 (16.87)	-0.1 (17.73)	-6.3 (19.49)
Median	0.0	-1.0	-9.0
Min, Max	-32.0, 40.0	-30.0, 48.0	-36.0, 42.0
End of treatment
n	83	84	82
Mean (SD)	-1.6 (17.76)	-2.8 (17.40)	-6.7 (16.98)
Median	0.0	-1.5	-8.0
Min, Max	-46.0, 48.0	-52.0, 48.0	-44.0, 42.0
After standing for 3 minutes
Week 24
n	58	27	30
Mean (SD)	-1.0 (15.80)	-0.1 (16.20)	-9.0 (16.88)
Median	-3.5	0.0	-8.0
Min, Max	-36.0, 38.0	-30.0, 30.0	-40.0, 30.0
End of treatment
n	83	83	81
Mean (SD)	-2.5 (16.61)	-3.5 (16.51)	-8.3 (15.21)
Median	-4.0	-4.0	-8.0
Min, Max	-40.0, 48.0	-52.0, 60.0	-40.0, 30.0
Diastolic Blood Pressure (mmHg)
After lying down for 5 minutes
Week 24
n	58	27	30
Mean (SD)	-0.8 (10.82)	-0.9 (7.71)	-2.2 (9.20)
Median	-0.5	-2.0	-1.0
Min, Max	-18.0, 41.0	-20.0, 16.0	-20.0, 21.0
End of treatment
n	83	84	82
Mean (SD)	-1.0 (10.99)	-2.0 (8.80)	-3.1 (8.79)
Median	0.0	-2.0	-4.0
Min, Max	-34.0, 41.0	-30.0, 18.0	-24.0, 21.0
After standing for 1 minute
Week 24
n	58	27	30
Mean (SD)	-2.3 (10.08)	1.0 (7.30)	-2.3 (10.85)
Median	-4.0	2.0	-7.0
Min, Max	-23.0, 24.0	-20.0, 18.0	-18.0, 22.0
End of treatment
n	83	84	82
Mean (SD)	-2.8 (10.17)	-1.2 (8.93)	-2.1 (12.10)
Median	-2.0	0.0	-2.0
Min, Max	-34.0, 24.0	-30.0, 20.0	-34.0, 28.0
After standing for 3 minutes
Week 24
n	58	27	30
Mean (SD)	-2.3 (9.56)	-1.6 (8.29)	-2.1 (9.77)
Median	-3.5	0.0	-3.5
Min, Max	-22.0, 20.0	-20.0, 10.0	-20.0, 16.0
End of treatment
n	83	83	81
Mean (SD)	-2.7 (9.36)	-1.8 (9.69)	-2.6 (10.81)
Median	-2.0	-1.0	-2.0
Min, Max	-30.0, 20.0	-24.0, 38.0	-40.0, 27.0
Pulse (beats/min)
After lying down for 5 minutes
Week 24
n	58	27	30
Mean (SD)	-0.3 (8.77)	-1.6 (10.53)	-2.0 (11.16)
Median	-1.0	0.0	-2.0
Min, Max	-24.0, 24.0	-24.0, 25.0	-34.0, 20.0
End of treatment
n	83	84	82
Mean (SD)	-0.9 (8.69)	-1.0 (11.12)	-1.7 (8.95)
Median	-1.0	-0.5	-2.0
Min, Max	-24.0, 24.0	-24.0, 32.0	-34.0, 20.0
After standing for 1 minute
Week 24
n	58	27	30
Mean (SD)	-1.7 (11.72)	-1.3 (9.05)	-1.8 (13.41)
Median	0.5	0.0	-3.0
Min, Max	-53.0, 18.0	-20.0, 12.0	-36.0, 20.0
End of treatment
n	83	84	82
Mean (SD)	-1.8 (11.05)	-0.5 (11.69)	-2.1 (10.43)
Median	-1.0	0.0	-1.5
Min, Max	-53.0, 20.0	-24.0, 34.0	-36.0, 22.0
After standing for 3 minutes
Week 24
n	58	27	30
Mean (SD)	-1.5 (10.47)	-2.1 (8.77)	-2.7 (11.12)
Median	0.0	-2.0	-2.0
Min, Max	-46.0, 14.0	-20.0, 16.0	-40.0, 14.0
End of treatment
n	83	83	81
Mean (SD)	-1.0 (9.89)	-0.7 (10.73)	-1.9 (9.49)
Median	0.0	-1.0	-1.0
Min, Max	-46.0, 18.0	-22.0, 29.0	-40.0, 20.0
Treatment groups are PLANNED treatment (TRT01P). Twelve subjects in this study received a treatment other than the one they were randomised to; grouping by actual treatment (TRT01A) would give column sizes of 86, 96 and 72.
Blood pressure and pulse are measured in three positions and each position is summarised as its own series: a subject's baseline after standing for three minutes is not the baseline for their supine measurement.
End of treatment is the last observed measurement of that parameter in that position, at a planned visit after Week 0 up to and including Week 24. Unscheduled visits, the Week 26 follow-up visit and records derived by averaging or carry-forward are never selected.
Change from baseline is the subject's value minus that subject's own observed Week 0 value in the same position. A subject with no Week 0 measurement contributes to no row here, so n can be one below the corresponding n in the vital signs summary.
n is the number of subjects contributing a change; N in the column header is the number of subjects in the safety analysis set.
Source: advs, adsl (pharmaverseadam). Data cut-off: 2014-07-01.
open.csr display t-vitals-change (post_text variant); generated from the committed ARD.

t-vitals-change

14.3.5.3 Summary of Weight and Weight Change from Baseline at End of Treatmentpost_text

t-weight · post_text variant · study CDISCPILOT01 · data cut-off 2014-07-01

	Placebo (N=86)	Xanomeline Low Dose (N=84)	Xanomeline High Dose (N=84)
Summary of Weight and Weight Change from Baseline at End of Treatment
Study CDISCPILOT01 — Safety Analysis Set
Weight (kg)
Baseline
n	86	83	84
Mean (SD)	62.8 (12.77)	67.3 (14.13)	70.0 (14.65)
Median	60.6	64.9	69.2
Min, Max	34.0, 86.2	45.4, 106.1	41.7, 108.0
Week 24
n	59	27	30
Mean (SD)	63.2 (12.58)	67.4 (14.07)	71.1 (15.82)
Median	63.5	62.6	68.7
Min, Max	34.0, 86.6	45.5, 106.1	49.9, 105.7
End of treatment
n	84	84	81
Mean (SD)	63.3 (12.66)	66.7 (14.32)	69.7 (14.00)
Median	64.0	65.9	70.3
Min, Max	34.0, 86.6	41.7, 106.1	42.2, 105.7
Weight change from baseline (kg)
Week 24
n	59	27	30
Mean (SD)	0.1 (2.30)	-0.3 (2.04)	1.0 (6.47)
Median	0.0	0.0	-0.2
Min, Max	-4.5, 8.2	-5.4, 3.2	-4.5, 33.3
End of treatment
n	84	83	81
Mean (SD)	0.2 (2.05)	-0.4 (2.41)	0.1 (4.19)
Median	0.0	0.0	-0.4
Min, Max	-4.5, 8.2	-14.5, 5.9	-5.5, 33.3
Treatment groups are PLANNED treatment (TRT01P). Twelve subjects in this study received a treatment other than the one they were randomised to; grouping by actual treatment (TRT01A) would give column sizes of 86, 96 and 72.
Baseline is the subject's observed Week 0 weight. Change from baseline is that subject's value minus that baseline, so a subject with no Week 0 weight contributes to the weight rows but not to the change rows.
End of treatment is the last observed weight at a planned visit after Week 0 up to and including Week 24. Unscheduled visits, the Week 26 follow-up visit and records derived by averaging or carry-forward are never selected.
n is the number of subjects contributing a measurement; N in the column header is the number of subjects in the safety analysis set.
Source: advs, adsl (pharmaverseadam). Data cut-off: 2014-07-01.
open.csr display t-weight (post_text variant); generated from the committed ARD.

t-weight

14.3.5.4 Summary of Concomitant Medications (Number of Subjects)post_text

t-conmeds · post_text variant · study CDISCPILOT01 · data cut-off 2014-07-01

	Placebo (N=86)	Xanomeline Low Dose (N=84)	Xanomeline High Dose (N=84)
Summary of Concomitant Medications (Number of Subjects)
Study CDISCPILOT01 — Safety Analysis Set
Subjects receiving at least one concomitant medication	77 (89.5%)	74 (88.1%)	78 (92.9%)
Therapeutic class and coded medication, n (%)
UNCODED	74 (86.0%)	70 (83.3%)	77 (91.7%)
UNCODED	74 (86.0%)	70 (83.3%)	77 (91.7%)
NERVOUS SYSTEM	23 (26.7%)	14 (16.7%)	8 (9.5%)
ACETYLSALICYLIC ACID	21 (24.4%)	11 (13.1%)	6 (7.1%)
DONEPEZIL HYDROCHLORIDE	1 (1.2%)	2 (2.4%)	2 (2.4%)
ALPRAZOLAM	1 (1.2%)	0 (0.0%)	0 (0.0%)
HALOPERIDOL	0 (0.0%)	1 (1.2%)	0 (0.0%)
PAROXETINE HYDROCHLORIDE	0 (0.0%)	1 (1.2%)	0 (0.0%)
SUMATRIPTAN	1 (1.2%)	0 (0.0%)	0 (0.0%)
SYSTEMIC HORMONAL PREPARATIONS, EXCL.	2 (2.3%)	13 (15.5%)	8 (9.5%)
HYDROCORTISONE	2 (2.3%)	13 (15.5%)	8 (9.5%)
ALIMENTARY TRACT AND METABOLISM	12 (14.0%)	11 (13.1%)	9 (10.7%)
CALCIUM	7 (8.1%)	6 (7.1%)	3 (3.6%)
NIZATIDINE	1 (1.2%)	1 (1.2%)	4 (4.8%)
ALGELDRATE	2 (2.3%)	0 (0.0%)	2 (2.4%)
SIMETICONE	0 (0.0%)	2 (2.4%)	0 (0.0%)
CALCIUM CARBONATE	0 (0.0%)	0 (0.0%)	1 (1.2%)
CIMETIDINE	0 (0.0%)	1 (1.2%)	0 (0.0%)
LOPERAMIDE HYDROCHLORIDE	1 (1.2%)	1 (1.2%)	1 (1.2%)
METFORMIN HYDROCHLORIDE	1 (1.2%)	1 (1.2%)	0 (0.0%)
CARDIOVASCULAR SYSTEM	12 (14.0%)	12 (14.3%)	7 (8.3%)
AMLODIPINE	8 (9.3%)	1 (1.2%)	2 (2.4%)
DIGOXIN	0 (0.0%)	3 (3.6%)	2 (2.4%)
DOXAZOSIN MESILATE	1 (1.2%)	2 (2.4%)	1 (1.2%)
FLUVASTATIN	0 (0.0%)	2 (2.4%)	0 (0.0%)
FUROSEMIDE	2 (2.3%)	2 (2.4%)	1 (1.2%)
LOSARTAN POTASSIUM	0 (0.0%)	2 (2.4%)	0 (0.0%)
NIFEDIPINE	2 (2.3%)	0 (0.0%)	0 (0.0%)
DILTIAZEM HYDROCHLORIDE	0 (0.0%)	0 (0.0%)	1 (1.2%)
FELODIPINE	0 (0.0%)	1 (1.2%)	0 (0.0%)
GENITO URINARY SYSTEM AND SEX HORMONES	6 (7.0%)	10 (11.9%)	5 (6.0%)
ESTROGENS CONJUGATED	6 (7.0%)	10 (11.9%)	5 (6.0%)
RESPIRATORY SYSTEM	4 (4.7%)	1 (1.2%)	4 (4.8%)
NAPROXEN SODIUM	1 (1.2%)	0 (0.0%)	3 (3.6%)
SALBUTAMOL SULFATE	2 (2.3%)	1 (1.2%)	0 (0.0%)
BUDESONIDE	0 (0.0%)	0 (0.0%)	1 (1.2%)
GUAIFENESIN	1 (1.2%)	0 (0.0%)	0 (0.0%)
IPRATROPIUM BROMIDE	1 (1.2%)	0 (0.0%)	0 (0.0%)
ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS	1 (1.2%)	0 (0.0%)	1 (1.2%)
LEUPRORELIN ACETATE	1 (1.2%)	0 (0.0%)	1 (1.2%)
BLOOD AND BLOOD FORMING ORGANS	0 (0.0%)	1 (1.2%)	0 (0.0%)
FERROUS SULFATE	0 (0.0%)	1 (1.2%)	0 (0.0%)
DERMATOLOGICALS	0 (0.0%)	0 (0.0%)	1 (1.2%)
CLOBETASOL PROPIONATE	0 (0.0%)	0 (0.0%)	1 (1.2%)
Treatment groups are PLANNED treatment (TRT01P). Twelve subjects in this study received a treatment other than the one they were randomised to; grouping by actual treatment (TRT01A) would give column sizes of 86, 96 and 72.
A subject is counted once per therapeutic class and once per coded medication, however many records they have. Class counts are therefore not the sum of the medication counts beneath them.
Every recorded medication counts, whether it was taken before, during or after treatment. Restricting to medications taken on treatment (ONTRTFL = 'Y') would count a much smaller set of records.
UNCODED is not a therapeutic class. It is how this study's data records a medication that was never coded to a dictionary term, and it is reported rather than dropped.
Classes, and the medications within a class, are ordered by the largest subject count in any treatment group, ties alphabetically. The reference document this display targets ordered them alphabetically by class instead.
Percentages are based on the number of subjects in the safety analysis set for each treatment group.
Source: adcm, adsl (pharmaverseadam). Data cut-off: 2014-07-01.
open.csr display t-conmeds (post_text variant); generated from the committed ARD.

t-conmeds

16 Appendices

Not populated in this demonstration.

16.1 Study Information

Not populated in this demonstration.

16.1.9 Documentation of Statistical Methods

Item	Value
displays[0].slug	t-disposition
displays[0].number	14.1.1
displays[0].title	Subject Disposition
displays[0].created	2026-07-27T03:23:35Z
displays[0].specHash	sha256:8c432e510cf8fe58349f0315cb25c51231c261a2276707cfd7168cd064a3d62d
displays[0].displayHash	sha256:18ca5acb502028c38848124b04a9db836b79b9072640bf54883c4ca98350a71d
displays[0].data[0].dataset	adsl
displays[0].data[0].hash	sha256:f9a1c3605cb277363fba0add4c4228df6a288685586575be159718696c582107
displays[0].data[0].n_row	254
displays[0].data[0].n_col	60
displays[0].data[0].source_pkg	pharmaverseadam
displays[0].data[0].source_version	1.1.0
displays[0].environment.r	4.3.3
displays[0].environment.os	Darwin 23.6.0
displays[0].environment.packages.cards	0.6.1
displays[0].environment.packages.cardx	0.2.5
displays[0].environment.packages.gtsummary	2.3.0
displays[0].environment.packages.gt	1.0.0
displays[0].environment.packages.dplyr	1.1.4
displays[0].environment.packages.pharmaverseadam	1.1.0
displays[0].environment.packages.jsonlite	2.0.0
displays[0].environment.packages.yaml	2.3.10
displays[0].environment.packages.digest	0.6.37
displays[0].source	outputs
displays[0].ardPath	outputs/t-disposition/v002/ard.json
displays[0].fixture	false
displays[1].slug	t-demographics
displays[1].number	14.1.2
displays[1].title	Demographic and Baseline Characteristics
displays[1].created	2026-07-27T03:23:35Z
displays[1].specHash	sha256:0f1e9b9029b61b70bfa00f93c9f0c52050859ff26cacb67ee2fed50c39392854
displays[1].displayHash	sha256:47d64c3c97e9a311b8b5bfdd7ae6d2a3cb1ff5a6442ad77664da993634c629bd
displays[1].data[0].dataset	adsl
displays[1].data[0].hash	sha256:f9a1c3605cb277363fba0add4c4228df6a288685586575be159718696c582107
displays[1].data[0].n_row	254
displays[1].data[0].n_col	60
displays[1].data[0].source_pkg	pharmaverseadam
displays[1].data[0].source_version	1.1.0
displays[1].environment.r	4.3.3
displays[1].environment.os	Darwin 23.6.0
displays[1].environment.packages.cards	0.6.1
displays[1].environment.packages.cardx	0.2.5
displays[1].environment.packages.gtsummary	2.3.0
displays[1].environment.packages.gt	1.0.0
displays[1].environment.packages.dplyr	1.1.4
displays[1].environment.packages.pharmaverseadam	1.1.0
displays[1].environment.packages.jsonlite	2.0.0
displays[1].environment.packages.yaml	2.3.10
displays[1].environment.packages.digest	0.6.37
displays[1].source	outputs
displays[1].ardPath	outputs/t-demographics/v002/ard.json
displays[1].fixture	false
displays[2].slug	t-exposure
displays[2].number	14.3.1.1
displays[2].title	Extent of Exposure to Study Drug
displays[2].created	2026-07-27T03:23:36Z
displays[2].specHash	sha256:dcb569bb84c890fe5d3322fbb111cdaeabd917ad388c89d10b2e754b8d322dd8
displays[2].displayHash	sha256:5cf918ab32731b85dcf031052e201c763ba0972d98f2badb1c8d7a216b812c44
displays[2].data[0].dataset	adsl
displays[2].data[0].hash	sha256:f9a1c3605cb277363fba0add4c4228df6a288685586575be159718696c582107
displays[2].data[0].n_row	254
displays[2].data[0].n_col	60
displays[2].data[0].source_pkg	pharmaverseadam
displays[2].data[0].source_version	1.1.0
displays[2].data[1].dataset	adex
displays[2].data[1].hash	sha256:e89d24c9364ba5a20a49a86de8428a8e4d8b35899b4d154ff83f89645c733f5f
displays[2].data[1].n_row	6315
displays[2].data[1].n_col	92
displays[2].data[1].source_pkg	pharmaverseadam
displays[2].data[1].source_version	1.1.0
displays[2].environment.r	4.3.3
displays[2].environment.os	Darwin 23.6.0
displays[2].environment.packages.cards	0.6.1
displays[2].environment.packages.cardx	0.2.5
displays[2].environment.packages.gtsummary	2.3.0
displays[2].environment.packages.gt	1.0.0
displays[2].environment.packages.dplyr	1.1.4
displays[2].environment.packages.pharmaverseadam	1.1.0
displays[2].environment.packages.jsonlite	2.0.0
displays[2].environment.packages.yaml	2.3.10
displays[2].environment.packages.digest	0.6.37
displays[2].source	outputs
displays[2].ardPath	outputs/t-exposure/v002/ard.json
displays[2].fixture	false
displays[3].slug	t-ae-overview
displays[3].number	14.3.1.2
displays[3].title	Overview of Treatment-Emergent Adverse Events
displays[3].created	2026-07-27T03:23:34Z
displays[3].specHash	sha256:6b0ba696f8cb4abffc3741982f36bb3bc4a47a68d84e0da1cb5cbf210c19a90a
displays[3].displayHash	sha256:04520444415a62c1f632d67d37a67e33c3f2a9dd4c9b7006cae32eb21bcdf2bb
displays[3].data[0].dataset	adsl
displays[3].data[0].hash	sha256:f9a1c3605cb277363fba0add4c4228df6a288685586575be159718696c582107
displays[3].data[0].n_row	254
displays[3].data[0].n_col	60
displays[3].data[0].source_pkg	pharmaverseadam
displays[3].data[0].source_version	1.1.0
displays[3].data[1].dataset	adae
displays[3].data[1].hash	sha256:7d4237afdbf934742091e6b7e0a756fcba6a0e79fc9f35b578f86574baf8f7d4
displays[3].data[1].n_row	1191
displays[3].data[1].n_col	105
displays[3].data[1].source_pkg	pharmaverseadam
displays[3].data[1].source_version	1.1.0
displays[3].environment.r	4.3.3
displays[3].environment.os	Darwin 23.6.0
displays[3].environment.packages.cards	0.6.1
displays[3].environment.packages.cardx	0.2.5
displays[3].environment.packages.gtsummary	2.3.0
displays[3].environment.packages.gt	1.0.0
displays[3].environment.packages.dplyr	1.1.4
displays[3].environment.packages.pharmaverseadam	1.1.0
displays[3].environment.packages.jsonlite	2.0.0
displays[3].environment.packages.yaml	2.3.10
displays[3].environment.packages.digest	0.6.37
displays[3].source	outputs
displays[3].ardPath	outputs/t-ae-overview/v002/ard.json
displays[3].fixture	false
displays[4].slug	t-ae-common
displays[4].number	14.3.1.3
displays[4].title	Treatment-Emergent Adverse Events by System Organ Class and Preferred Term
displays[4].created	2026-07-27T03:23:32Z
displays[4].specHash	sha256:a45e3a1f2586dd0bffa2e2f660162d958e9ae20f6eb87df9511b7d49b5c74203
displays[4].displayHash	sha256:c749510c8b10f6e4f45381eacb9d85aca93d56e62e9b5f2b71f41d050d112433
displays[4].data[0].dataset	adsl
displays[4].data[0].hash	sha256:f9a1c3605cb277363fba0add4c4228df6a288685586575be159718696c582107
displays[4].data[0].n_row	254
displays[4].data[0].n_col	60
displays[4].data[0].source_pkg	pharmaverseadam
displays[4].data[0].source_version	1.1.0
displays[4].data[1].dataset	adae
displays[4].data[1].hash	sha256:7d4237afdbf934742091e6b7e0a756fcba6a0e79fc9f35b578f86574baf8f7d4
displays[4].data[1].n_row	1191
displays[4].data[1].n_col	105
displays[4].data[1].source_pkg	pharmaverseadam
displays[4].data[1].source_version	1.1.0
displays[4].environment.r	4.3.3
displays[4].environment.os	Darwin 23.6.0
displays[4].environment.packages.cards	0.6.1
displays[4].environment.packages.cardx	0.2.5
displays[4].environment.packages.gtsummary	2.3.0
displays[4].environment.packages.gt	1.0.0
displays[4].environment.packages.dplyr	1.1.4
displays[4].environment.packages.pharmaverseadam	1.1.0
displays[4].environment.packages.jsonlite	2.0.0
displays[4].environment.packages.yaml	2.3.10
displays[4].environment.packages.digest	0.6.37
displays[4].source	outputs
displays[4].ardPath	outputs/t-ae-common/v003/ard.json
displays[4].fixture	false
displays[5].slug	l-ae-serious
displays[5].number	14.3.2.1
displays[5].title	Listing of Serious Adverse Events
displays[5].created	2026-07-27T03:23:31Z
displays[5].specHash	sha256:a046fb1cdc11ed10d586284efeb97e30ab743f4ad394869bd83ae1bfb401d140
displays[5].displayHash	sha256:b865356eb33a50fb5cabae395251d60df06c7607485231ce1ae9516804af6523
displays[5].data[0].dataset	adsl
displays[5].data[0].hash	sha256:f9a1c3605cb277363fba0add4c4228df6a288685586575be159718696c582107
displays[5].data[0].n_row	254
displays[5].data[0].n_col	60
displays[5].data[0].source_pkg	pharmaverseadam
displays[5].data[0].source_version	1.1.0
displays[5].data[1].dataset	adae
displays[5].data[1].hash	sha256:7d4237afdbf934742091e6b7e0a756fcba6a0e79fc9f35b578f86574baf8f7d4
displays[5].data[1].n_row	1191
displays[5].data[1].n_col	105
displays[5].data[1].source_pkg	pharmaverseadam
displays[5].data[1].source_version	1.1.0
displays[5].environment.r	4.3.3
displays[5].environment.os	Darwin 23.6.0
displays[5].environment.packages.cards	0.6.1
displays[5].environment.packages.cardx	0.2.5
displays[5].environment.packages.gtsummary	2.3.0
displays[5].environment.packages.gt	1.0.0
displays[5].environment.packages.dplyr	1.1.4
displays[5].environment.packages.pharmaverseadam	1.1.0
displays[5].environment.packages.jsonlite	2.0.0
displays[5].environment.packages.yaml	2.3.10
displays[5].environment.packages.digest	0.6.37
displays[5].source	outputs
displays[5].ardPath	outputs/l-ae-serious/v002/ard.json
displays[5].fixture	false
displays[6].slug	t-vitals
displays[6].number	14.3.5.1
displays[6].title	Summary of Vital Signs at Baseline and End of Treatment
displays[6].created	2026-08-27T04:06:01Z
displays[6].specHash	sha256:2aeb25861d2864c68dec7cb56a37435df974e048d036e1a3a1b256a5604d4290
displays[6].displayHash	sha256:faa409af7dbd05b5409f52ae6c23560eb497e6a4db308db4647ba54ad93b9ef7
displays[6].data[0].dataset	adsl
displays[6].data[0].hash	sha256:83b1d423d2b40766af8138864699137cfb6e0ccb064ca25369c1ed7216936918
displays[6].data[0].n_row	254
displays[6].data[0].n_col	60
displays[6].data[0].source_pkg	pharmaverseadam
displays[6].data[0].source_version	1.1.0
displays[6].data[1].dataset	advs
displays[6].data[1].hash	sha256:7be440388501966144aa18f3d460cc9e4bb783eb8312df196aa6dfb7502e685b
displays[6].data[1].n_row	65032
displays[6].data[1].n_col	108
displays[6].data[1].source_pkg	pharmaverseadam
displays[6].data[1].source_version	1.1.0
displays[6].environment.r	4.3.3
displays[6].environment.os	Darwin 23.6.0
displays[6].environment.packages.cards	0.6.1
displays[6].environment.packages.cardx	0.2.5
displays[6].environment.packages.gtsummary	2.3.0
displays[6].environment.packages.gt	1.0.0
displays[6].environment.packages.dplyr	1.1.4
displays[6].environment.packages.pharmaverseadam	1.1.0
displays[6].environment.packages.jsonlite	2.0.0
displays[6].environment.packages.yaml	2.3.10
displays[6].environment.packages.digest	0.6.37
displays[6].source	outputs
displays[6].ardPath	outputs/t-vitals/v001/ard.json
displays[6].fixture	false
displays[7].slug	t-vitals-change
displays[7].number	14.3.5.2
displays[7].title	Summary of Vital Signs Change from Baseline at End of Treatment
displays[7].created	2026-08-27T04:06:03Z
displays[7].specHash	sha256:0d204e9c533b1d93eb583c63b8aa9eac5db5b6c58b7ea53e4609d472abbd2f6b
displays[7].displayHash	sha256:590c09c0f2481bc89ee2e9f5bd6011a95861fbd02fad072b4771518acf4af54c
displays[7].data[0].dataset	adsl
displays[7].data[0].hash	sha256:83b1d423d2b40766af8138864699137cfb6e0ccb064ca25369c1ed7216936918
displays[7].data[0].n_row	254
displays[7].data[0].n_col	60
displays[7].data[0].source_pkg	pharmaverseadam
displays[7].data[0].source_version	1.1.0
displays[7].data[1].dataset	advs
displays[7].data[1].hash	sha256:7be440388501966144aa18f3d460cc9e4bb783eb8312df196aa6dfb7502e685b
displays[7].data[1].n_row	65032
displays[7].data[1].n_col	108
displays[7].data[1].source_pkg	pharmaverseadam
displays[7].data[1].source_version	1.1.0
displays[7].environment.r	4.3.3
displays[7].environment.os	Darwin 23.6.0
displays[7].environment.packages.cards	0.6.1
displays[7].environment.packages.cardx	0.2.5
displays[7].environment.packages.gtsummary	2.3.0
displays[7].environment.packages.gt	1.0.0
displays[7].environment.packages.dplyr	1.1.4
displays[7].environment.packages.pharmaverseadam	1.1.0
displays[7].environment.packages.jsonlite	2.0.0
displays[7].environment.packages.yaml	2.3.10
displays[7].environment.packages.digest	0.6.37
displays[7].source	outputs
displays[7].ardPath	outputs/t-vitals-change/v001/ard.json
displays[7].fixture	false
displays[8].slug	t-weight
displays[8].number	14.3.5.3
displays[8].title	Summary of Weight and Weight Change from Baseline at End of Treatment
displays[8].created	2026-08-27T04:10:09Z
displays[8].specHash	sha256:14be68b3bc1d72d8c3e7ff6c067edb41004ad68be9286479c3c2e9a9891dfff3
displays[8].displayHash	sha256:c1a16fd08c4c081a335923ab9efb7260cfb7e031db4384c9695c301dfa64e0a3
displays[8].data[0].dataset	adsl
displays[8].data[0].hash	sha256:83b1d423d2b40766af8138864699137cfb6e0ccb064ca25369c1ed7216936918
displays[8].data[0].n_row	254
displays[8].data[0].n_col	60
displays[8].data[0].source_pkg	pharmaverseadam
displays[8].data[0].source_version	1.1.0
displays[8].data[1].dataset	advs
displays[8].data[1].hash	sha256:7be440388501966144aa18f3d460cc9e4bb783eb8312df196aa6dfb7502e685b
displays[8].data[1].n_row	65032
displays[8].data[1].n_col	108
displays[8].data[1].source_pkg	pharmaverseadam
displays[8].data[1].source_version	1.1.0
displays[8].environment.r	4.3.3
displays[8].environment.os	Darwin 23.6.0
displays[8].environment.packages.cards	0.6.1
displays[8].environment.packages.cardx	0.2.5
displays[8].environment.packages.gtsummary	2.3.0
displays[8].environment.packages.gt	1.0.0
displays[8].environment.packages.dplyr	1.1.4
displays[8].environment.packages.pharmaverseadam	1.1.0
displays[8].environment.packages.jsonlite	2.0.0
displays[8].environment.packages.yaml	2.3.10
displays[8].environment.packages.digest	0.6.37
displays[8].source	outputs
displays[8].ardPath	outputs/t-weight/v001/ard.json
displays[8].fixture	false
displays[9].slug	t-conmeds
displays[9].number	14.3.5.4
displays[9].title	Summary of Concomitant Medications (Number of Subjects)
displays[9].created	2026-08-27T04:06:04Z
displays[9].specHash	sha256:5b8045eb70da88bc2f3876b8a6fc2d35c907e604991fe8e467f4f32c097c32d1
displays[9].displayHash	sha256:6f1a46f8b7d057f930f1afffb6ed27c0566d1d981b0a59d2cdbde42f28853519
displays[9].data[0].dataset	adsl
displays[9].data[0].hash	sha256:83b1d423d2b40766af8138864699137cfb6e0ccb064ca25369c1ed7216936918
displays[9].data[0].n_row	254
displays[9].data[0].n_col	60
displays[9].data[0].source_pkg	pharmaverseadam
displays[9].data[0].source_version	1.1.0
displays[9].data[1].dataset	adcm
displays[9].data[1].hash	sha256:28e100aaeacdd8ed81825a2278d7e76658ba508e0306bb2d659e44ff443eee0b
displays[9].data[1].n_row	7510
displays[9].data[1].n_col	95
displays[9].data[1].source_pkg	pharmaverseadam
displays[9].data[1].source_version	1.1.0
displays[9].environment.r	4.3.3
displays[9].environment.os	Darwin 23.6.0
displays[9].environment.packages.cards	0.6.1
displays[9].environment.packages.cardx	0.2.5
displays[9].environment.packages.gtsummary	2.3.0
displays[9].environment.packages.gt	1.0.0
displays[9].environment.packages.dplyr	1.1.4
displays[9].environment.packages.pharmaverseadam	1.1.0
displays[9].environment.packages.jsonlite	2.0.0
displays[9].environment.packages.yaml	2.3.10
displays[9].environment.packages.digest	0.6.37
displays[9].source	outputs
displays[9].ardPath	outputs/t-conmeds/v001/ard.json
displays[9].fixture	false