ClinwrightCSR
The clinical study report: ADaM, the CSR's tables, and apps on the data
By Administrator, 2026-10-17.
Made from SDTM snapshot DBR1.
ADaM data sets
| Data set | Label | Records |
|---|---|---|
| ADSL | Subject-Level Analysis | 254 |
| ADADAS | ADAS-Cog Analysis | 14,724 |
| ADCIBC | CIBIC+ Analysis | 730 |
| ADLBC | Analysis Dataset Lab Blood Chemistry | 37,168 |
| ADNPIX | NPI-X Item Analysis Data | 61,939 |
| ADVS | Vital Signs Analysis Dataset | 32,389 |
| ADAE | Adverse Events Analysis Dataset | 1,191 |
| ADCM | Concomitant Medications Analysis Dataset | 7,510 |
| ADMH | Medical History Analysis Dataset | 1,818 |
| ADEX | Exposure Analysis Dataset | 2,032 |
| ADLBH | Analysis Dataset Lab Hematology | 25,014 |
| ADTTE | AE Time To 1st Derm. Event Analysis | 254 |
Tables, listings and figures
| Output | Title | Kind | Made |
|---|---|---|---|
| 14-1.01 | Summary of Populations | table | 2026-10-17 |
| 14-1.02 | Summary of End of Study Data | table | 2026-10-17 |
| 14-1.03 | Summary of Number of Subjects By Site | table | 2026-10-17 |
| 14-2.01 | Summary of Demographic and Baseline Characteristics | table | 2026-10-17 |
| 14-4.01 | Summary of Planned Exposure to Study Drug, as of End of Study | table | 2026-10-17 |
| 14-3.01 | Primary Endpoint Analysis: ADAS Cog (11) - Change from Baseline to Week 24 - LOCF | table | 2026-10-17 |
| 14-3.02 | Primary Endpoint Analysis: CIBIC+ - Summary at Week 24 - LOCF | table | 2026-10-17 |
| 14-3.03 | ADAS Cog (11) - Change from Baseline to Week 8 - LOCF | table | 2026-10-17 |
| 14-3.04 | CIBIC+ - Summary at Week 8 - LOCF | table | 2026-10-17 |
| 14-3.05 | ADAS Cog (11) - Change from Baseline to Week 16 - LOCF | table | 2026-10-17 |
| 14-3.06 | CIBIC+ - Summary at Week 16 - LOCF | table | 2026-10-17 |
| 14-3.07 | ADAS Cog (11) - Change from Baseline to Week 24 - Completers at Wk 24-Observed Cases-Windowed | table | 2026-10-17 |
| 14-3.08 | ADAS Cog (11) - Change from Baseline to Week 24 in Male Subjects - LOCF | table | 2026-10-17 |
| 14-3.09 | ADAS Cog (11) - Change from Baseline to Week 24 in Female Subjects - LOCF | table | 2026-10-17 |
| 14-3.12 | Mean NPI-X Total Score from Week 4 through Week 24 - Windowed | table | not yet |
| 14-3.10 | ADAS Cog (11) - Mean and Mean Change from Baseline over Time | table | 2026-10-17 |
| 14-5.01 | Incidence of Treatment Emergent Adverse Events by Treatment Group | table | 2026-10-17 |
| 14-5.02 | Incidence of Treatment Emergent Serious Adverse Events by Treatment Group | table | 2026-10-17 |
| 14-7.04 | Summary of Concomitant Medications (Number of Subjects) | table | 2026-10-17 |
| 14-7.01 | Summary of Vital Signs at Baseline and End of Treatment | table | 2026-10-17 |
| 14-7.02 | Summary of Vital Signs Change from Baseline at End of Treatment | table | 2026-10-17 |
| 14-7.03 | Summary of Weight Change from Baseline at End of Treatment | table | 2026-10-17 |
| 14-6.01 | Summary Statistics for Continuous Laboratory Values | table | 2026-10-17 |
| 14-6.02 | Frequency of Normal and Abnormal (Beyond Normal Range) Laboratory Values During Treatment | table | not yet |
| 14-6.03 | Frequency of Normal and Abnormal (Clinically Significant Change from Previous Visit) Laboratory Values During Treatment | table | not yet |
| 14-6.04 | Shifts of Laboratory Values During Treatment, Categorized Based on Threshold Ranges, by Visit | table | 2026-10-17 |
| 14-6.05 | Shifts of Laboratory Values During Treatment, Categorized Based on Threshold Ranges | table | not yet |
| 14-6.06 | Shifts of Hy's Law Values During Treatment | table | not yet |
| 14-3.13 | CIBIC+ - Categorical Analysis - LOCF | table | 2026-10-17 |
| 14-3.11 | ADAS Cog (11) - Repeated Measures Analysis of Change from Baseline to Week 24 | table | 2026-10-17 |
Apps
- ADAS-Cog (11): change from baseline The primary endpoint by visit and treatment, in the population and with the missing values chosen, and the SAP's ANCOVA at the chosen week.
- Adverse events by treatment Treatment-emergent adverse events of one treatment by system organ class and preferred term, and the most frequent terms.
- Baseline characteristics The demographic and baseline characteristics ticked, by treatment and in total, as the CSR's Table 14.1.1 shows them; saves as RTF.
- Hepatic safety (eDISH) Each subject's peak transaminase against peak bilirubin (x ULN), the Hy's law quadrant, and a subject's liver tests over time.
- Shiny port: AE drill down Linked choices, an action button and conditional panels on the pilot's SDTM AE.
- Shiny port: Baseline clusters The gallery's k-means with plot clicks on the pilot's baseline measures (ADSL).
- Shiny port: Data browser 02_text, 03_reactivity, 09_upload and 11_timer on the pilot's SDTM and ADaM data.
- Shiny port: Laboratory values Shiny 01_hello, 04_mpg, 05_sliders and 06_tabsets on the pilot's chemistry data (ADLBC).
- Shiny port: Study dashboard shinydashboard and 08_html on the pilot: pages, value boxes, cards, markdown, dates.
- Shiny port: Subject explorer The gallery's movie explorer, brushing and downloads on the pilot's subjects (ADSL).
- Subject profile Pick subjects in the list for their adverse events and laboratory values over time, a tab each.
- Subjects The safety population by treatment, sex and age: counts, a plot of height and weight to select subjects from, and the subjects as a CSV file.
- Time to first dermatologic event Kaplan-Meier estimates by treatment in the safety population, with the log-rank test.
Deliveries
| Delivery | SDTM | Made |
|---|---|---|
| CSR final ADaM, outputs, programs, logs and define.xml | SDTM snapshot DBR1 | 2026-10-17 |