1 Administrative Information
Not populated in this demonstration. Annex I's header block. E3 prints these as labelled cells rather than as numbered sections; open.csr numbers them so each field is separately addressable by an assembly, a text block and a cross-reference.
1.1 Name of Sponsor, Finished Product and Active Ingredient
This synopsis is an open.csr demonstration report. It carries no sponsor: the
underlying data are the CDISC pilot study ADaM datasets published in the
pharmaverseadam package under the Apache License, and the report around them was
assembled by the open.csr framework to exercise its own machinery end to end.
The finished product studied is the Xanomeline Transdermal Therapeutic System (TTS). The active ingredient is xanomeline.
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1.2 Title of Study
Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer's Disease.
The protocol identifier is CDISCPILOT01.
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1.3 Investigators and Study Centres
The study was conducted at multiple centres. Individual investigator and centre identities are not carried in the ADaM extract this demonstration is built from, so no coordinating investigator is named here.
In a real report this field cross-references the list of investigators in the appendices, and the by-site enrolment summary that accompanies it.
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1.4 Publication (Reference)
None. The CDISC pilot study is a teaching dataset distributed for standards work and is not a published clinical trial.
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1.5 Studied Period
Dates of first enrolment and last completed visit are not carried in the ADaM extract this demonstration is built from and are therefore not reported.
All analyses in this synopsis and in the accompanying clinical study report were produced against a single data cutoff of 2014-07-01, and every number in both documents resolves to the same committed analysis results datasets taken at that cutoff.
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1.6 Phase of Development
Phase 2.
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2 Objectives
The stated objectives of the CDISC pilot study were to evaluate the efficacy and safety of transdermal xanomeline in patients with mild to moderate Alzheimer's disease.
The objective of this report is narrower and should not be mistaken for the study's: it is to demonstrate that a clinical study report and its synopsis can be assembled mechanically from analysis results datasets, a library of text blocks and a library of named values, such that every number in the prose is traceable to the row of the analysis dataset it came from. Efficacy is therefore out of scope here (see the efficacy sections, which are deliberately left unpopulated), and the demonstration is confined to safety.
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3 Methodology
Randomised, double-blind, placebo-controlled, parallel-group.
Patients were assigned to one of three arms: placebo, xanomeline low dose, or xanomeline high dose.
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4 Number of Patients (Planned and Analysed)
The planned sample size is not carried in the ADaM extract this demonstration is built from. Of the patients actually enrolled, {{value:randomised-n}} were randomised and {{value:treated-n}} were treated and form the safety analysis set, which is the population analysed throughout this synopsis.
{{value:completed-n}} patients ({{value:completed-pct}}%) completed the study and {{value:discontinued-n}} discontinued prematurely. Disposition by treatment group is given in 13.1.
Every figure in this paragraph is a binding into the named values store, not a typed number. The same store supplies the same figures to the disposition section of the full clinical study report, so the two documents cannot disagree: if the underlying analysis results dataset changes, both change together, and if a value in the store no longer re-derives from the committed dataset the build fails before either document is written.
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| Subject Disposition (Summary) | ||||
| Study CDISCPILOT01 — Intent-to-Treat Analysis Set | ||||
| Placebo (N=86) | Xanomeline Low Dose (N=84) | Xanomeline High Dose (N=84) | Total (N=254) | |
|---|---|---|---|---|
| Disposition, n (%) | ||||
| Subjects randomised | ||||
| Subjects treated | ||||
| Completed the study | ||||
| Discontinued the study | ||||
| Reason for discontinuation, n (%) | ||||
| Death | ||||
| Other / not specified | ||||
| Deaths, n (%) | ||||
| Died on study | ||||
| 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 (CDISCPILOT01 ADaM package, phuse-org/phuse-scripts). Data cut-off: 2014-07-01. | ||||
| open.csr display t-disposition (in_text variant); generated from the committed ARD. | ||||
5 Diagnosis and Main Criteria for Inclusion
Patients with mild to moderate Alzheimer's disease.
The full inclusion and exclusion criteria are a property of the protocol and are not derivable from the analysis datasets; in a real report this field is authored prose reviewed against the protocol, and open.csr classifies it as a boilerplate block for exactly that reason — it carries no bindings, so no gate can vouch for it, and it must be approved by a person.
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6 Test Product, Dose and Mode of Administration, Batch Number
Xanomeline, administered transdermally as a Transdermal Therapeutic System (TTS) patch, at a low dose and a high dose.
Dose strengths and batch numbers are properties of the protocol and the investigational product record and are not carried in the analysis datasets, so they are not reported here.
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7 Duration of Treatment
Mean duration of exposure to study drug was 149.1 days in the placebo group, 99.0 days in the xanomeline low dose group and 99.4 days in the xanomeline high dose group.
Exposure differed substantially between the groups, which matters for the reading of the safety results below: crude proportions of patients reporting an event are not exposure-adjusted. The extent of exposure is summarised in 13.3.
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| Extent of Exposure (Summary) | ||||
| Study CDISCPILOT01 — Safety Analysis Set | ||||
| Placebo (N=86) | Xanomeline Low Dose (N=84) | Xanomeline High Dose (N=84) | Total (N=254) | |
|---|---|---|---|---|
| Safety population | ||||
| Average daily dose (mg) | ||||
| n | ||||
| Mean | ||||
| SD | ||||
| Median | ||||
| Min | ||||
| Max | ||||
| Cumulative dose at end of study (mg) | ||||
| n | ||||
| Mean | ||||
| SD | ||||
| Median | ||||
| Min | ||||
| Max | ||||
| Completers at Week 24 | ||||
| Average daily dose (mg) | ||||
| n | ||||
| Mean | ||||
| SD | ||||
| Median | ||||
| Min | ||||
| Max | ||||
| Cumulative dose at end of study (mg) | ||||
| n | ||||
| Mean | ||||
| SD | ||||
| Median | ||||
| Min | ||||
| Max | ||||
| Duration of treatment (days) — not in the reference table | ||||
| n | ||||
| Mean | ||||
| SD | ||||
| Median | ||||
| Min | ||||
| Max | ||||
| Cumulative exposure, n (%) — not in the reference table | ||||
| ≥ 1 day | ||||
| ≥ 30 days | ||||
| ≥ 90 days | ||||
| ≥ 180 days | ||||
| Average daily dose and cumulative dose are the subject-level AVGDD and CUMDOSE the study's own ADaM package carries; no exposure (ADEX) dataset is used. End of study is Week 26 or early termination. | ||||
| The reference report (Table 14-4.01) presents completers at Week 24 and the safety population as two column groups. This display presents the same statistics with the two populations as row blocks under one set of treatment columns; no number differs. | ||||
| Completers at Week 24 are the subjects flagged COMP24FL = 'Y' in the safety analysis set: 60, 28 and 30 subjects. | ||||
| Duration of treatment (ADSL TRTDUR, days from first to last dose inclusive) and the cumulative exposure categories over it are not part of the reference table; they are carried here because the narrative in Section 12.1 quotes them. A subject treated for 200 days is counted in every category up to 180 days. | ||||
| Placebo subjects have a planned dose of zero, so every placebo dose statistic is 0. The Total column pools the three treatment groups. | ||||
| Source: adsl (CDISCPILOT01 ADaM package, phuse-org/phuse-scripts). Data cut-off: 2014-07-01. | ||||
| open.csr display t-exposure (in_text variant); generated from the committed ARD. | ||||
8 Reference Therapy, Dose and Mode of Administration, Batch Number
Matching placebo patch. Batch numbers are not carried in the analysis datasets.
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9 Criteria for Evaluation
Not populated in this demonstration.
9.1 Efficacy
Not populated in this demonstration.
9.2 Safety
Safety was evaluated from treatment-emergent adverse events, coded to system organ class and preferred term, and summarised by treatment group; from serious adverse events, deaths and adverse events leading to withdrawal; and from the extent of exposure to study drug.
Laboratory values, vital signs and concomitant medications are collected in the source study and are analysed in the reference clinical study report for this dataset, but no analysis results datasets for them exist in this framework yet, so they are not evaluated here.
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10 Statistical Methods
Descriptive statistics only. Continuous measures are summarised as number of patients, mean, standard deviation, median, quartiles, minimum and maximum; categorical measures as counts and percentages of the analysis population. No hypothesis test is performed and no confidence interval is presented, so nothing in this synopsis should be read as a statistical comparison between groups.
Each summary is produced once, as an analysis results dataset, and every rendering of it — the in-text table, the post-text table, and each number quoted in this prose — is read back from that one dataset. The generated provenance appendix records, for each display, which dataset the numbers came from.
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11 Summary — Conclusions
Not populated in this demonstration.
11.1 Efficacy Results
Not populated in this demonstration.
11.2 Safety Results
Treatment-emergent adverse events were reported by {{value:ae-any-n-total}} patients in the safety analysis set overall. In the xanomeline high dose group they were reported by {{value:ae-any-pct-high}}% of the {{value:safety-n-high}} patients treated.
The proportion reporting at least one event rose with dose: {{value:ae-any-n-placebo}} patients receiving placebo compared with {{value:ae-any-n-xanomeline}} across the two xanomeline arms combined — an excess of {{value:ae-excess-high-vs-placebo}} patients in the high dose arm relative to placebo. An overview of treatment-emergent adverse events is given in 13.4; events by system organ class and preferred term, and the listing of deaths, serious adverse events and adverse events leading to withdrawal, accompany this synopsis in Section 13.
The combined and difference figures above are derived values: the store declares them as structural arithmetic over other named values rather than storing an answer, so the assembler re-evaluates them at build time against the committed analysis results datasets. A derived value that no longer reproduces is a build failure, not a footnote.
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| Overview of Treatment-Emergent Adverse Events (Summary) | ||||
| Study CDISCPILOT01 — Safety Analysis Set | ||||
| Placebo (N=86) | Xanomeline Low Dose (N=84) | Xanomeline High Dose (N=84) | Total (N=254) | |
|---|---|---|---|---|
| Adverse events | ||||
| Number of events | ||||
| Subjects with ≥1 adverse event | ||||
| Subjects with a serious adverse event | ||||
| Subjects with a fatal adverse event | ||||
| Subjects with a related adverse event | ||||
| Subjects by severity, n (%) | ||||
| Mild | ||||
| Moderate | ||||
| Severe | ||||
| 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 (CDISCPILOT01 ADaM package, phuse-org/phuse-scripts). Data cut-off: 2014-07-01. | ||||
| open.csr display t-ae-overview (in_text variant); generated from the committed ARD. | ||||
11.3 Conclusion
No clinical conclusion is drawn. This is a demonstration report built on a teaching dataset, and the only claim it makes is about its own construction: that the numbers in its prose, the numbers in its tables and the numbers in the full clinical study report assembled from the same library are the same numbers, and that this is enforced by the build rather than asserted by a reviewer.
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12 Date of the Report
This synopsis carries no fixed report date. It is regenerated from the library on every build, and the build stamp recorded in the provenance appendix is its date.
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13 Supporting Displays
| Subject Disposition | ||||
| Study CDISCPILOT01 — Intent-to-Treat Analysis Set | ||||
| Placebo (N=86) | Xanomeline Low Dose (N=84) | Xanomeline High Dose (N=84) | Total (N=254) | |
|---|---|---|---|---|
| Disposition, n (%) | ||||
| Subjects randomised | ||||
| Subjects treated | ||||
| Completed the study | ||||
| Discontinued the study | ||||
| Reason for discontinuation, n (%) | ||||
| Death | ||||
| Other / not specified | ||||
| Deaths, n (%) | ||||
| Died on study | ||||
| 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 (CDISCPILOT01 ADaM package, phuse-org/phuse-scripts). Data cut-off: 2014-07-01. | ||||
| open.csr display t-disposition (post_text variant); generated from the committed ARD. | ||||
| Summary of Demographic and Baseline Characteristics | |||||
| Study CDISCPILOT01 — Intent-to-Treat | |||||
| Placebo (N=86) | Xanomeline Low Dose (N=84) | Xanomeline High Dose (N=84) | Total (N=254) | p-value | |
|---|---|---|---|---|---|
| Age (y) | |||||
| n | |||||
| Mean | |||||
| SD | |||||
| Median | |||||
| Min | |||||
| Max | |||||
| <65 yrs | |||||
| 65-80 yrs | |||||
| >80 yrs | |||||
| Sex | |||||
| n | |||||
| Male | |||||
| Female | |||||
| Race (Origin) | |||||
| n | |||||
| Caucasian | |||||
| African Descent | |||||
| Hispanic | |||||
| Other | |||||
| MMSE | |||||
| n | |||||
| Mean | |||||
| SD | |||||
| Median | |||||
| Min | |||||
| Max | |||||
| Duration of disease | |||||
| n | |||||
| Mean | |||||
| SD | |||||
| Median | |||||
| Min | |||||
| Max | |||||
| <12 months | |||||
| >=12 months | |||||
| Years of education | |||||
| n | |||||
| Mean | |||||
| SD | |||||
| Median | |||||
| Min | |||||
| Max | |||||
| Baseline weight(kg) | |||||
| n | |||||
| Mean | |||||
| SD | |||||
| Median | |||||
| Min | |||||
| Max | |||||
| Baseline height(cm) | |||||
| n | |||||
| Mean | |||||
| SD | |||||
| Median | |||||
| Min | |||||
| Max | |||||
| Baseline BMI | |||||
| n | |||||
| Mean | |||||
| SD | |||||
| Median | |||||
| Min | |||||
| Max | |||||
| <25 | |||||
| 25-<30 | |||||
| >=30 | |||||
| [1] P-values are results of ANOVA treatment group comparison for continuous variables and Pearson's chi-square test for categorical variables, as the reference report (Table 14-2.01) states; each block carries one test across the three treatment groups. | |||||
| Race (Origin) is the reference report's classification, with Hispanic as a category. The study's ADaM carries race and ethnicity separately (230 White, 23 Black or African American, 1 American Indian or Alaska Native; 12 Hispanic or Latino, all of them White by race). The recode is ethnicity first, then race: 218 Caucasian, 23 African Descent, 12 Hispanic, 1 Other. It is a coding convention, not a disagreement between the data and the report. | |||||
| Duration of disease is DURDIS, months from onset of the first definite symptoms of Alzheimer's disease to enrolment, as the study's ADaM carries it. Years of education is EDUCLVL. MMSE is MMSETOT. | |||||
| n is the number of subjects with a value; one subject on low dose has no baseline weight or BMI. Percentages are based on the number of subjects in the intent-to-treat population for each treatment group; the Total column pools the three groups. Treatment groups are planned treatment, TRT01P, which agrees with actual treatment for every subject in this study. | |||||
| Source: adsl (CDISCPILOT01 ADaM package, phuse-org/phuse-scripts). Data cut-off: 2014-07-01. | |||||
| open.csr display t-demographics (post_text variant); generated from the committed ARD. | |||||
| Summary of Planned Exposure to Study Drug, as of End of Study | ||||
| Study CDISCPILOT01 — Safety Analysis Set | ||||
| Placebo (N=86) | Xanomeline Low Dose (N=84) | Xanomeline High Dose (N=84) | Total (N=254) | |
|---|---|---|---|---|
| Safety population | ||||
| Average daily dose (mg) | ||||
| n | ||||
| Mean | ||||
| SD | ||||
| Median | ||||
| Min | ||||
| Max | ||||
| Cumulative dose at end of study (mg) | ||||
| n | ||||
| Mean | ||||
| SD | ||||
| Median | ||||
| Min | ||||
| Max | ||||
| Completers at Week 24 | ||||
| Average daily dose (mg) | ||||
| n | ||||
| Mean | ||||
| SD | ||||
| Median | ||||
| Min | ||||
| Max | ||||
| Cumulative dose at end of study (mg) | ||||
| n | ||||
| Mean | ||||
| SD | ||||
| Median | ||||
| Min | ||||
| Max | ||||
| Duration of treatment (days) — not in the reference table | ||||
| n | ||||
| Mean | ||||
| SD | ||||
| Median | ||||
| Min | ||||
| Max | ||||
| Cumulative exposure, n (%) — not in the reference table | ||||
| ≥ 1 day | ||||
| ≥ 30 days | ||||
| ≥ 90 days | ||||
| ≥ 180 days | ||||
| Average daily dose and cumulative dose are the subject-level AVGDD and CUMDOSE the study's own ADaM package carries; no exposure (ADEX) dataset is used. End of study is Week 26 or early termination. | ||||
| The reference report (Table 14-4.01) presents completers at Week 24 and the safety population as two column groups. This display presents the same statistics with the two populations as row blocks under one set of treatment columns; no number differs. | ||||
| Completers at Week 24 are the subjects flagged COMP24FL = 'Y' in the safety analysis set: 60, 28 and 30 subjects. | ||||
| Duration of treatment (ADSL TRTDUR, days from first to last dose inclusive) and the cumulative exposure categories over it are not part of the reference table; they are carried here because the narrative in Section 12.1 quotes them. A subject treated for 200 days is counted in every category up to 180 days. | ||||
| Placebo subjects have a planned dose of zero, so every placebo dose statistic is 0. The Total column pools the three treatment groups. | ||||
| Source: adsl (CDISCPILOT01 ADaM package, phuse-org/phuse-scripts). Data cut-off: 2014-07-01. | ||||
| open.csr display t-exposure (post_text variant); generated from the committed ARD. | ||||
| Overview of Treatment-Emergent Adverse Events | ||||
| Study CDISCPILOT01 — Safety Analysis Set | ||||
| Placebo (N=86) | Xanomeline Low Dose (N=84) | Xanomeline High Dose (N=84) | Total (N=254) | |
|---|---|---|---|---|
| Adverse events | ||||
| Number of events | ||||
| Subjects with ≥1 adverse event | ||||
| Subjects with a serious adverse event | ||||
| Subjects with a fatal adverse event | ||||
| Subjects with a related adverse event | ||||
| Subjects by severity, n (%) | ||||
| Mild | ||||
| Moderate | ||||
| Severe | ||||
| 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 (CDISCPILOT01 ADaM package, phuse-org/phuse-scripts). Data cut-off: 2014-07-01. | ||||
| open.csr display t-ae-overview (post_text variant); generated from the committed ARD. | ||||
| Treatment-Emergent Adverse Events by System Organ Class and Preferred Term | ||||
| Study CDISCPILOT01 — Safety Analysis Set | ||||
| Placebo (N=86) | Xanomeline Low Dose (N=84) | Xanomeline High Dose (N=84) | Total (N=254) | |
|---|---|---|---|---|
| GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | ||||
| APPLICATION SITE PRURITUS | ||||
| APPLICATION SITE ERYTHEMA | ||||
| APPLICATION SITE DERMATITIS | ||||
| APPLICATION SITE IRRITATION | ||||
| APPLICATION SITE VESICLES | ||||
| FATIGUE | ||||
| OEDEMA PERIPHERAL | ||||
| APPLICATION SITE SWELLING | ||||
| APPLICATION SITE URTICARIA | ||||
| CHILLS | ||||
| MALAISE | ||||
| PYREXIA | ||||
| APPLICATION SITE PAIN | ||||
| APPLICATION SITE PERSPIRATION | ||||
| APPLICATION SITE REACTION | ||||
| ASTHENIA | ||||
| CHEST DISCOMFORT | ||||
| CHEST PAIN | ||||
| OEDEMA | ||||
| PAIN | ||||
| APPLICATION SITE BLEEDING | ||||
| APPLICATION SITE DESQUAMATION | ||||
| APPLICATION SITE DISCHARGE | ||||
| APPLICATION SITE DISCOLOURATION | ||||
| APPLICATION SITE INDURATION | ||||
| APPLICATION SITE WARMTH | ||||
| FEELING ABNORMAL | ||||
| FEELING COLD | ||||
| INFLAMMATION | ||||
| SECRETION DISCHARGE | ||||
| SUDDEN DEATH | ||||
| SWELLING | ||||
| ULCER | ||||
| SKIN AND SUBCUTANEOUS TISSUE DISORDERS | ||||
| PRURITUS | ||||
| ERYTHEMA | ||||
| RASH | ||||
| HYPERHIDROSIS | ||||
| SKIN IRRITATION | ||||
| BLISTER | ||||
| RASH PRURITIC | ||||
| PRURITUS GENERALISED | ||||
| URTICARIA | ||||
| ACTINIC KERATOSIS | ||||
| ALOPECIA | ||||
| COLD SWEAT | ||||
| DERMATITIS CONTACT | ||||
| DRUG ERUPTION | ||||
| RASH ERYTHEMATOUS | ||||
| RASH MACULO-PAPULAR | ||||
| SKIN EXFOLIATION | ||||
| SKIN ODOUR ABNORMAL | ||||
| SKIN ULCER | ||||
| NERVOUS SYSTEM DISORDERS | ||||
| DIZZINESS | ||||
| HEADACHE | ||||
| SYNCOPE | ||||
| SOMNOLENCE | ||||
| TRANSIENT ISCHAEMIC ATTACK | ||||
| BURNING SENSATION | ||||
| LETHARGY | ||||
| AMNESIA | ||||
| BALANCE DISORDER | ||||
| COGNITIVE DISORDER | ||||
| COMPLEX PARTIAL SEIZURES | ||||
| COORDINATION ABNORMAL | ||||
| HEMIANOPIA HOMONYMOUS | ||||
| HYPERSOMNIA | ||||
| PARAESTHESIA | ||||
| PARAESTHESIA ORAL | ||||
| PARKINSON'S DISEASE | ||||
| PAROSMIA | ||||
| PARTIAL SEIZURES WITH SECONDARY GENERALISATION | ||||
| PSYCHOMOTOR HYPERACTIVITY | ||||
| STUPOR | ||||
| SYNCOPE VASOVAGAL | ||||
| GASTROINTESTINAL DISORDERS | ||||
| DIARRHOEA | ||||
| VOMITING | ||||
| NAUSEA | ||||
| ABDOMINAL PAIN | ||||
| SALIVARY HYPERSECRETION | ||||
| DYSPEPSIA | ||||
| ABDOMINAL DISCOMFORT | ||||
| CONSTIPATION | ||||
| DYSPHAGIA | ||||
| FLATULENCE | ||||
| GASTROINTESTINAL HAEMORRHAGE | ||||
| GASTROOESOPHAGEAL REFLUX DISEASE | ||||
| GLOSSITIS | ||||
| HIATUS HERNIA | ||||
| RECTAL HAEMORRHAGE | ||||
| STOMACH DISCOMFORT | ||||
| CARDIAC DISORDERS | ||||
| SINUS BRADYCARDIA | ||||
| MYOCARDIAL INFARCTION | ||||
| ATRIAL FIBRILLATION | ||||
| SUPRAVENTRICULAR EXTRASYSTOLES | ||||
| VENTRICULAR EXTRASYSTOLES | ||||
| ATRIAL FLUTTER | ||||
| ATRIOVENTRICULAR BLOCK FIRST DEGREE | ||||
| BUNDLE BRANCH BLOCK RIGHT | ||||
| PALPITATIONS | ||||
| ATRIAL HYPERTROPHY | ||||
| ATRIOVENTRICULAR BLOCK SECOND DEGREE | ||||
| BRADYCARDIA | ||||
| BUNDLE BRANCH BLOCK LEFT | ||||
| CARDIAC DISORDER | ||||
| CARDIAC FAILURE CONGESTIVE | ||||
| SINUS ARRHYTHMIA | ||||
| SUPRAVENTRICULAR TACHYCARDIA | ||||
| TACHYCARDIA | ||||
| VENTRICULAR HYPERTROPHY | ||||
| WOLFF-PARKINSON-WHITE SYNDROME | ||||
| INFECTIONS AND INFESTATIONS | ||||
| NASOPHARYNGITIS | ||||
| UPPER RESPIRATORY TRACT INFECTION | ||||
| INFLUENZA | ||||
| URINARY TRACT INFECTION | ||||
| CYSTITIS | ||||
| EAR INFECTION | ||||
| BRONCHITIS | ||||
| CELLULITIS | ||||
| CERVICITIS | ||||
| GASTROENTERITIS VIRAL | ||||
| HORDEOLUM | ||||
| LOCALISED INFECTION | ||||
| LOWER RESPIRATORY TRACT INFECTION | ||||
| PNEUMONIA | ||||
| RHINITIS | ||||
| VAGINAL MYCOSIS | ||||
| VIRAL INFECTION | ||||
| PSYCHIATRIC DISORDERS | ||||
| CONFUSIONAL STATE | ||||
| AGITATION | ||||
| INSOMNIA | ||||
| ANXIETY | ||||
| DELUSION | ||||
| IRRITABILITY | ||||
| COMPLETED SUICIDE | ||||
| DELIRIUM | ||||
| DEPRESSED MOOD | ||||
| DISORIENTATION | ||||
| HALLUCINATION | ||||
| HALLUCINATION, VISUAL | ||||
| LIBIDO DECREASED | ||||
| LISTLESS | ||||
| NIGHTMARE | ||||
| RESTLESSNESS | ||||
| RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS | ||||
| COUGH | ||||
| NASAL CONGESTION | ||||
| DYSPNOEA | ||||
| EPISTAXIS | ||||
| PHARYNGOLARYNGEAL PAIN | ||||
| RHINORRHOEA | ||||
| ALLERGIC GRANULOMATOUS ANGIITIS | ||||
| DYSPHONIA | ||||
| EMPHYSEMA | ||||
| HAEMOPTYSIS | ||||
| PHARYNGEAL ERYTHEMA | ||||
| POSTNASAL DRIP | ||||
| PRODUCTIVE COUGH | ||||
| RALES | ||||
| RESPIRATORY TRACT CONGESTION | ||||
| INVESTIGATIONS | ||||
| ELECTROCARDIOGRAM ST SEGMENT DEPRESSION | ||||
| ELECTROCARDIOGRAM T WAVE INVERSION | ||||
| BLOOD GLUCOSE INCREASED | ||||
| ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED | ||||
| BIOPSY | ||||
| BIOPSY PROSTATE | ||||
| BLOOD ALKALINE PHOSPHATASE INCREASED | ||||
| BLOOD CHOLESTEROL INCREASED | ||||
| BLOOD CREATINE PHOSPHOKINASE INCREASED | ||||
| BLOOD URINE PRESENT | ||||
| BODY TEMPERATURE INCREASED | ||||
| CYSTOSCOPY | ||||
| HEART RATE INCREASED | ||||
| HEART RATE IRREGULAR | ||||
| NASAL MUCOSA BIOPSY | ||||
| WEIGHT DECREASED | ||||
| MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS | ||||
| BACK PAIN | ||||
| ARTHRALGIA | ||||
| SHOULDER PAIN | ||||
| MUSCLE SPASMS | ||||
| ARTHRITIS | ||||
| FLANK PAIN | ||||
| MUSCULAR WEAKNESS | ||||
| MYALGIA | ||||
| PAIN IN EXTREMITY | ||||
| INJURY, POISONING AND PROCEDURAL COMPLICATIONS | ||||
| CONTUSION | ||||
| EXCORIATION | ||||
| FALL | ||||
| HIP FRACTURE | ||||
| SKIN LACERATION | ||||
| FACIAL BONES FRACTURE | ||||
| JOINT DISLOCATION | ||||
| WOUND | ||||
| RENAL AND URINARY DISORDERS | ||||
| MICTURITION URGENCY | ||||
| DYSURIA | ||||
| NEPHROLITHIASIS | ||||
| CALCULUS URETHRAL | ||||
| INCONTINENCE | ||||
| POLLAKIURIA | ||||
| METABOLISM AND NUTRITION DISORDERS | ||||
| DECREASED APPETITE | ||||
| FOOD CRAVING | ||||
| INCREASED APPETITE | ||||
| DEHYDRATION | ||||
| DIABETES MELLITUS | ||||
| HYPONATRAEMIA | ||||
| VASCULAR DISORDERS | ||||
| HYPOTENSION | ||||
| HYPERTENSION | ||||
| HOT FLUSH | ||||
| ORTHOSTATIC HYPOTENSION | ||||
| WOUND HAEMORRHAGE | ||||
| EYE DISORDERS | ||||
| VISION BLURRED | ||||
| CONJUNCTIVAL HAEMORRHAGE | ||||
| CONJUNCTIVITIS | ||||
| EYE ALLERGY | ||||
| EYE PRURITUS | ||||
| EYE SWELLING | ||||
| SURGICAL AND MEDICAL PROCEDURES | ||||
| CATARACT OPERATION | ||||
| ACROCHORDON EXCISION | ||||
| EYE LASER SURGERY | ||||
| SKIN LESION EXCISION | ||||
| EAR AND LABYRINTH DISORDERS | ||||
| VERTIGO | ||||
| CERUMEN IMPACTION | ||||
| EAR PAIN | ||||
| CONGENITAL, FAMILIAL AND GENETIC DISORDERS | ||||
| VENTRICULAR SEPTAL DEFECT | ||||
| NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS) | ||||
| COLON CANCER | ||||
| MALIGNANT FIBROUS HISTIOCYTOMA | ||||
| PROSTATE CANCER | ||||
| REPRODUCTIVE SYSTEM AND BREAST DISORDERS | ||||
| BENIGN PROSTATIC HYPERPLASIA | ||||
| PELVIC PAIN | ||||
| HEPATOBILIARY DISORDERS | ||||
| HYPERBILIRUBINAEMIA | ||||
| IMMUNE SYSTEM DISORDERS | ||||
| HYPERSENSITIVITY | ||||
| SOCIAL CIRCUMSTANCES | ||||
| ALCOHOL USE | ||||
| 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 (CDISCPILOT01 ADaM package, phuse-org/phuse-scripts). Data cut-off: 2014-07-01. | ||||
| open.csr display t-ae-common (post_text variant); generated from the committed ARD. | ||||
| Listing of Serious Adverse Events | |||||||||||
| Study CDISCPILOT01 — Safety Analysis Set | |||||||||||
| Subject | Treatment | Age | Sex | System organ class | Preferred term | Severity | Relationship | Start day | End day | Outcome | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | |||||||||||
| 2 | |||||||||||
| 3 | |||||||||||
| One row per serious adverse event record (AESER = 'Y'). | |||||||||||
| Study day is relative to the first dose of study drug. | |||||||||||
| Source: adae (CDISCPILOT01 ADaM package, phuse-org/phuse-scripts). Data cut-off: 2014-07-01. | |||||||||||
| open.csr display l-ae-serious (post_text variant); generated from the committed ARD. | |||||||||||
14 Provenance of the Assembled Synopsis
| Display | Title | Spec / display | Input data | Environment | Commit |
|---|---|---|---|---|---|
| t-disposition 13.1 | Subject Disposition | 8c432e5 c00f247 | adsl 254 rows · 70c7278 | R 4.3.3 | uncommitted 2026-09-02 |
| t-demographics 13.2 | Summary of Demographic and Baseline Characteristics | bc60600 c2a1f17 | adsl 254 rows · b022f78 | R 4.3.3 | uncommitted 2026-09-02 |
| t-exposure 13.3 | Summary of Planned Exposure to Study Drug, as of End of Study | 065027f d4dbe63 | adsl 254 rows · 70c7278 | R 4.3.3 | uncommitted 2026-09-02 |
| t-ae-overview 13.4 | Overview of Treatment-Emergent Adverse Events | 6b0ba69 ea18faf | adsl 254 rows · 70c7278 adae 1191 rows · 4ffe4e4 | R 4.3.3 | uncommitted 2026-09-02 |
| t-ae-common 13.5 | Treatment-Emergent Adverse Events by System Organ Class and Preferred Term | a45e3a1 3027c71 | adsl 254 rows · 70c7278 adae 1191 rows · 4ffe4e4 | R 4.3.3 | uncommitted 2026-09-02 |
| l-ae-serious 13.6 | Listing of Serious Adverse Events | a046fb1 11a00d0 | adsl 254 rows · 70c7278 adae 1191 rows · 4ffe4e4 | R 4.3.3 | uncommitted 2026-09-02 |
| t-populations | Summary of Populations | c8dbaff 9ac815d | adsl 254 rows · 70c7278 | R 4.3.3 | uncommitted 2026-09-02 |