Metadata / specs
Metadata
Specifications
Every display and value, as declared, with history
Specifications
A display is declared twice — what to compute (analysis.yaml) and how to show it (display.yaml) — and every rebuild keeps a snapshot of both beside the ARD, so the history below is the specification's, iteration by iteration, with the hashes each manifest recorded.
t-demographics Demographic and Baseline Characteristics DMT01
- Type
- table
- E3 position
- §14.1
- Files
- analysis library/tfl/t-demographics/analysis.yaml
display library/tfl/t-demographics/display.yaml
custom library/tfl/t-demographics/custom.R - Current
- v007 · spec bc60600 · display c2a1f17 · ARD 87af027
| Iteration | Created | Actor | Change request | Spec | Display | ARD |
|---|---|---|---|---|---|---|
| v001 | 2026-07-25T06:39:06Z | @jwildfire | Initial generation of DMT01 from the statistical analysis plan shell. | 0f1e9b9 | 47d64c3 | 67ad8d0 |
| v002 | 2026-07-27T03:23:35Z | @obotclaw | Add submission-format RTF artifacts to every variant (obot.roadmap #129 A). | 0f1e9b9 | 47d64c3 | e03ca47 |
| v003 | 2026-09-02T15:19:11Z | @obotclaw | One study (D0032 R2, #60): read the CDISC pilot own ADaM package, which assigns every subject the arm the rest of the report uses. Spec unchanged; lane changed. | 0f1e9b9 | 42749da | f2f974a |
| v004 | 2026-09-02T15:39:23Z | @obotclaw | Table 14-2.01 of the reference report (D0032, #61): intent-to-treat population, a Total and a p-value column (one-way ANOVA / Pearson chi-square per block), the report rows — age and its groups, sex, Race (Origin) recoded from race and ethnicity, MMSE, duration of disease and its groups, years of education, baseline weight, height, BMI and its groups. The FDA-standard DMT01 shape is superseded; CDISC-coded race and ethnicity stay in the ARD for the narrative bindings. | 1db216c | b2e005b | c9e63ef |
| v005 | 2026-09-02T15:44:12Z | @obotclaw | The sub-1% percentage presentation made a display option (format: sub_one_pct) rather than an engine rule: the reference end-of-study table prints 1 ( 0%) where its demographics table prints 1 ( <1%). Every cell unchanged. | 1db216c | ce6678b | 3516f69 |
| v006 | 2026-09-02T16:10:27Z | @obotclaw | In-text variant redrawn as the reference report prints it (Tables 11-1, 12-1, 12-4; D0032, #63). | 1db216c | ce6678b | 7e45dc8 |
| v007 | 2026-09-02T16:11:27Z | @obotclaw | In-text variant redrawn as the reference report prints it (Tables 11-1, 12-1, 12-4; D0032, #63). | bc60600 | c2a1f17 | 87af027 |
t-disposition Subject Disposition DST01
- Type
- table
- E3 position
- §14.1
- Files
- analysis library/tfl/t-disposition/analysis.yaml
display library/tfl/t-disposition/display.yaml - Current
- v003 · spec 8c432e5 · display c00f247 · ARD 5a073a0
| Iteration | Created | Actor | Change request | Spec | Display | ARD |
|---|---|---|---|---|---|---|
| v001 | 2026-07-25T06:39:07Z | @jwildfire | Initial generation of DST01 from the statistical analysis plan shell. | 8c432e5 | 18ca5ac | 1f4596b |
| v002 | 2026-07-27T03:23:35Z | @obotclaw | Add submission-format RTF artifacts to every variant (obot.roadmap #129 A). | 8c432e5 | 18ca5ac | 26f5652 |
| v003 | 2026-09-02T15:19:12Z | @obotclaw | One study (D0032 R2, #60): read the CDISC pilot own ADaM package, which assigns every subject the arm the rest of the report uses. Spec unchanged; lane changed. | 8c432e5 | c00f247 | 5a073a0 |
t-populations Summary of Populations DST02
- Type
- table
- E3 position
- §14.1
- Files
- analysis library/tfl/t-populations/analysis.yaml
display library/tfl/t-populations/display.yaml - Current
- v003 · spec c8dbaff · display 9ac815d · ARD a78a73c
| Iteration | Created | Actor | Change request | Spec | Display | ARD |
|---|---|---|---|---|---|---|
| v001 | 2026-08-27T02:18:05Z | @jwildfire | Initial generation of DST02 from the CDISCPILOT01 statistical analysis plan (Attachment 13.1.1 Template 1). | f65fbf8 | a67aeb9 | a096a1d |
| v002 | 2026-08-27T03:44:48Z | @obotclaw | Correct the population line. The reference report runs Table 14-1.01 over All Subjects; this display claimed Intent-to-Treat, and t-end-of-study claimed the reverse — the two were transcribed the wrong way round. In this study both select the same 254 subjects, so no figure moves; the table now states the population its reference states. The footnotes now name the two things this display defines that the reference does not: the derivation of Complete Study, and the meaning of N. | c8dbaff | 9ac815d | 61a333a |
| v003 | 2026-09-02T15:23:26Z | @obotclaw | One study (D0032 R2, #59): regenerated so the ARD carries its population record for the treatment-consistency gate. Spec and lane unchanged; every statistic identical. | c8dbaff | 9ac815d | a78a73c |
t-end-of-study Summary of End of Study Data DST03
- Type
- table
- E3 position
- §14.1
- Files
- analysis library/tfl/t-end-of-study/analysis.yaml
display library/tfl/t-end-of-study/display.yaml
custom library/tfl/t-end-of-study/custom.R - Current
- v003 · spec d39450d · display 6a7d3f3 · ARD 4969678
| Iteration | Created | Actor | Change request | Spec | Display | ARD |
|---|---|---|---|---|---|---|
| v001 | 2026-08-27T02:18:15Z | @jwildfire | Initial generation of DST03 from the CDISCPILOT01 statistical analysis plan (Attachment 13.1.1 Template 2). | b223011 | 8ec9802 | 979dd87 |
| v002 | 2026-08-27T03:44:50Z | @obotclaw | Correct the population line. The reference report runs Table 14-1.02 over Intent-to-Treat; this display claimed All Subjects. In this study both select the same 254 subjects, so no figure moves. The footnote for N now says where its wording departs from the reference. | d39450d | 6a7d3f3 | 2a40e4c |
| v003 | 2026-09-02T15:23:25Z | @obotclaw | One study (D0032 R2, #59): regenerated so the ARD carries its population record for the treatment-consistency gate. Spec and lane unchanged; every statistic identical. | d39450d | 6a7d3f3 | 4969678 |
f-derm-time-to-event Time to Dermatologic Event by Treatment Group AEF01
- Type
- figure
- E3 position
- §14.2
- Files
- analysis library/tfl/f-derm-time-to-event/analysis.yaml
display library/tfl/f-derm-time-to-event/display.yaml
custom library/tfl/f-derm-time-to-event/custom.R - Current
- v002 · spec dd67fc1 · display a900fd7 · ARD dae95ac
| Iteration | Created | Actor | Change request | Spec | Display | ARD |
|---|---|---|---|---|---|---|
| v001 | 2026-08-27T05:00:35Z | @jwildfire | Initial generation of Figure 14-1: Kaplan-Meier estimates of time to first dermatologic event, from the study own analysis results metadata (define.xml ResultDisplay Figure_14-1, PROC LIFETEST) and SAP section 11.2. | dd67fc1 | a900fd7 | 2b62328 |
| v002 | 2026-09-02T15:23:21Z | @obotclaw | One study (D0032 R2, #59): regenerated so the ARD carries its population record for the treatment-consistency gate. Spec and lane unchanged; every statistic identical. | dd67fc1 | a900fd7 | dae95ac |
t-cibic-week24 Primary Endpoint Analysis: CIBIC+ — Summary at Week 24 — LOCF EFF02
- Type
- table
- E3 position
- §14.2
- Files
- analysis library/tfl/t-cibic-week24/analysis.yaml
display library/tfl/t-cibic-week24/display.yaml
custom library/tfl/t-cibic-week24/custom.R - Current
- v004 · spec 190d176 · display c326ce8 · ARD a8f78f3
| Iteration | Created | Actor | Change request | Spec | Display | ARD |
|---|---|---|---|---|---|---|
| v001 | 2026-08-27T02:19:21Z | @jwildfire | Initial generation from CDISCPILOT01 Table 14-3.02. | 190d176 | 7d1c968 | b467544 |
| v002 | 2026-08-27T02:37:29Z | @jwildfire | Initial generation. | 190d176 | 7d1c968 | ac80459 |
| v003 | 2026-08-27T03:53:36Z | @jwildfire | Correct the digit plan so the pipeline reads it. The entry `N: 0` was resolved by YAML 1.1 as the boolean key FALSE, so the display declared a precision for N that no renderer ever saw; the key is now quoted. No statistic moves - the engine default for a count is the same zero decimals the specification asked for - and this regeneration is the proof of that. | 190d176 | c326ce8 | e45ea11 |
| v004 | 2026-09-02T15:23:21Z | @obotclaw | One study (D0032 R2, #59): regenerated so the ARD carries its population record for the treatment-consistency gate. Spec and lane unchanged; every statistic identical. | 190d176 | c326ce8 | a8f78f3 |
t-cibic-week8 CIBIC+ — Summary at Week 8 — LOCF EFF03
- Type
- table
- E3 position
- §14.2
- Files
- analysis library/tfl/t-cibic-week8/analysis.yaml
display library/tfl/t-cibic-week8/display.yaml
custom library/tfl/t-cibic-week8/custom.R - Current
- v002 · spec d243537 · display 9e6e7dd · ARD 3073ee5
| Iteration | Created | Actor | Change request | Spec | Display | ARD |
|---|---|---|---|---|---|---|
| v001 | 2026-08-27T03:53:34Z | @jwildfire | Initial generation of EFF03 from CDISCPILOT01 Table 14-3.04 and the analysis results metadata for Table_14-3.02, which states the model. | d243537 | 9e6e7dd | 7e4e612 |
| v002 | 2026-09-02T15:23:22Z | @obotclaw | One study (D0032 R2, #59): regenerated so the ARD carries its population record for the treatment-consistency gate. Spec and lane unchanged; every statistic identical. | d243537 | 9e6e7dd | 3073ee5 |
t-cibic-week16 CIBIC+ — Summary at Week 16 — LOCF EFF04
- Type
- table
- E3 position
- §14.2
- Files
- analysis library/tfl/t-cibic-week16/analysis.yaml
display library/tfl/t-cibic-week16/display.yaml
custom library/tfl/t-cibic-week16/custom.R - Current
- v002 · spec 00a39ba · display ddcd203 · ARD 4f25a6b
| Iteration | Created | Actor | Change request | Spec | Display | ARD |
|---|---|---|---|---|---|---|
| v001 | 2026-08-27T03:53:35Z | @jwildfire | Initial generation of EFF04 from CDISCPILOT01 Table 14-3.06 and the analysis results metadata for Table_14-3.02, which states the model. | 00a39ba | ddcd203 | f3551f2 |
| v002 | 2026-09-02T15:23:21Z | @obotclaw | One study (D0032 R2, #59): regenerated so the ARD carries its population record for the treatment-consistency gate. Spec and lane unchanged; every statistic identical. | 00a39ba | ddcd203 | 4f25a6b |
t-cibic-categorical CIBIC+ — Categorical Analysis — LOCF EFF05
- Type
- table
- E3 position
- §14.2
- Files
- analysis library/tfl/t-cibic-categorical/analysis.yaml
display library/tfl/t-cibic-categorical/display.yaml
custom library/tfl/t-cibic-categorical/custom.R - Current
- v002 · spec f6675d7 · display 3e86f7c · ARD 4847131
| Iteration | Created | Actor | Change request | Spec | Display | ARD |
|---|---|---|---|---|---|---|
| v001 | 2026-08-27T03:53:35Z | @jwildfire | Initial generation of EFF05 from CDISCPILOT01 Table 14-3.13. | f6675d7 | 3e86f7c | bf869c3 |
| v002 | 2026-09-02T15:23:21Z | @obotclaw | One study (D0032 R2, #59): regenerated so the ARD carries its population record for the treatment-consistency gate. Spec and lane unchanged; every statistic identical. | f6675d7 | 3e86f7c | 4847131 |
t-eff-adas-wk24 Primary Endpoint Analysis: ADAS-Cog (11) - Change from Baseline to Week 24 - LOCF EFT01
- Type
- table
- E3 position
- §14.2
- Files
- analysis library/tfl/t-eff-adas-wk24/analysis.yaml
display library/tfl/t-eff-adas-wk24/display.yaml
custom library/tfl/t-eff-adas-wk24/custom.R - Current
- v002 · spec b129304 · display e51fda2 · ARD 6e4dd40
| Iteration | Created | Actor | Change request | Spec | Display | ARD |
|---|---|---|---|---|---|---|
| v001 | 2026-08-27T02:21:19Z | obot worker | Initial generation of the ADAS-Cog Week 24 primary efficacy display (#43). | b129304 | e51fda2 | 7769370 |
| v002 | 2026-09-02T15:23:23Z | @obotclaw | One study (D0032 R2, #59): regenerated so the ARD carries its population record for the treatment-consistency gate. Spec and lane unchanged; every statistic identical. | b129304 | e51fda2 | 6e4dd40 |
t-eff-adas-wk8 ADAS-Cog (11) - Change from Baseline to Week 8 - LOCF EFT02
- Type
- table
- E3 position
- §14.2
- Files
- analysis library/tfl/t-eff-adas-wk8/analysis.yaml
display library/tfl/t-eff-adas-wk8/display.yaml
custom library/tfl/t-eff-adas-wk8/custom.R - Current
- v002 · spec 6508cc4 · display 675584e · ARD ec13102
| Iteration | Created | Actor | Change request | Spec | Display | ARD |
|---|---|---|---|---|---|---|
| v001 | 2026-08-27T02:21:30Z | obot worker | Initial generation of the ADAS-Cog efficacy displays (#43). | 6508cc4 | 675584e | c9148b1 |
| v002 | 2026-09-02T15:23:24Z | @obotclaw | One study (D0032 R2, #59): regenerated so the ARD carries its population record for the treatment-consistency gate. Spec and lane unchanged; every statistic identical. | 6508cc4 | 675584e | ec13102 |
t-eff-adas-wk16 ADAS-Cog (11) - Change from Baseline to Week 16 - LOCF EFT03
- Type
- table
- E3 position
- §14.2
- Files
- analysis library/tfl/t-eff-adas-wk16/analysis.yaml
display library/tfl/t-eff-adas-wk16/display.yaml
custom library/tfl/t-eff-adas-wk16/custom.R - Current
- v002 · spec 304b616 · display 6bbf55b · ARD dd7d1cd
| Iteration | Created | Actor | Change request | Spec | Display | ARD |
|---|---|---|---|---|---|---|
| v001 | 2026-08-27T02:21:31Z | obot worker | Initial generation of the ADAS-Cog efficacy displays (#43). | 304b616 | 6bbf55b | 6d94a1f |
| v002 | 2026-09-02T15:23:23Z | @obotclaw | One study (D0032 R2, #59): regenerated so the ARD carries its population record for the treatment-consistency gate. Spec and lane unchanged; every statistic identical. | 304b616 | 6bbf55b | dd7d1cd |
t-eff-adas-wk24-completers ADAS-Cog (11) - Change from Baseline to Week 24 - Completers at Week 24, Observed Cases, Windowed EFT04
- Type
- table
- E3 position
- §14.2
- Files
- analysis library/tfl/t-eff-adas-wk24-completers/analysis.yaml
display library/tfl/t-eff-adas-wk24-completers/display.yaml
custom library/tfl/t-eff-adas-wk24-completers/custom.R - Current
- v002 · spec 09b7453 · display 4cf74d8 · ARD 9c9aef7
| Iteration | Created | Actor | Change request | Spec | Display | ARD |
|---|---|---|---|---|---|---|
| v001 | 2026-08-27T03:41:22Z | obot worker W0137 | Complete the preserved specification: first generation of numbers and rendered output. | 09b7453 | 4cf74d8 | fd50f5c |
| v002 | 2026-09-02T15:23:24Z | @obotclaw | One study (D0032 R2, #59): regenerated so the ARD carries its population record for the treatment-consistency gate. Spec and lane unchanged; every statistic identical. | 09b7453 | 4cf74d8 | 9c9aef7 |
t-eff-adas-wk24-male ADAS-Cog (11) - Change from Baseline to Week 24 in Male Subjects - LOCF EFT05
- Type
- table
- E3 position
- §14.2
- Files
- analysis library/tfl/t-eff-adas-wk24-male/analysis.yaml
display library/tfl/t-eff-adas-wk24-male/display.yaml
custom library/tfl/t-eff-adas-wk24-male/custom.R - Current
- v002 · spec f08b78f · display cc16d83 · ARD bf57631
| Iteration | Created | Actor | Change request | Spec | Display | ARD |
|---|---|---|---|---|---|---|
| v001 | 2026-08-27T03:41:23Z | obot worker W0137 | Complete the preserved specification: first generation of numbers and rendered output. | f08b78f | cc16d83 | f4ecc3b |
| v002 | 2026-09-02T15:23:24Z | @obotclaw | One study (D0032 R2, #59): regenerated so the ARD carries its population record for the treatment-consistency gate. Spec and lane unchanged; every statistic identical. | f08b78f | cc16d83 | bf57631 |
t-eff-adas-wk24-female ADAS-Cog (11) - Change from Baseline to Week 24 in Female Subjects - LOCF EFT06
- Type
- table
- E3 position
- §14.2
- Files
- analysis library/tfl/t-eff-adas-wk24-female/analysis.yaml
display library/tfl/t-eff-adas-wk24-female/display.yaml
custom library/tfl/t-eff-adas-wk24-female/custom.R - Current
- v002 · spec 9b0ea9b · display 97fcb12 · ARD 92e3885
| Iteration | Created | Actor | Change request | Spec | Display | ARD |
|---|---|---|---|---|---|---|
| v001 | 2026-08-27T03:41:23Z | obot worker W0137 | Complete the preserved specification: first generation of numbers and rendered output. | 9b0ea9b | 97fcb12 | a6fddf0 |
| v002 | 2026-09-02T15:23:24Z | @obotclaw | One study (D0032 R2, #59): regenerated so the ARD carries its population record for the treatment-consistency gate. Spec and lane unchanged; every statistic identical. | 9b0ea9b | 97fcb12 | 92e3885 |
t-eff-adas-overtime ADAS-Cog (11) - Mean and Mean Change from Baseline over Time EFT07
- Type
- table
- E3 position
- §14.2
- Files
- analysis library/tfl/t-eff-adas-overtime/analysis.yaml
display library/tfl/t-eff-adas-overtime/display.yaml
custom library/tfl/t-eff-adas-overtime/custom.R - Current
- v002 · spec 37f6ffa · display cc82b9a · ARD ae89465
| Iteration | Created | Actor | Change request | Spec | Display | ARD |
|---|---|---|---|---|---|---|
| v001 | 2026-08-27T03:52:26Z | obot worker W0137 | First generation of the over-time summary (reference report Table 14-3.10). | 37f6ffa | cc82b9a | 41c5098 |
| v002 | 2026-09-02T15:23:23Z | @obotclaw | One study (D0032 R2, #59): regenerated so the ARD carries its population record for the treatment-consistency gate. Spec and lane unchanged; every statistic identical. | 37f6ffa | cc82b9a | ae89465 |
t-eff-adas-mmrm ADAS-Cog (11) - Repeated Measures Analysis of Change from Baseline to Week 24 EFT08
- Type
- table
- E3 position
- §14.2
- Files
- analysis library/tfl/t-eff-adas-mmrm/analysis.yaml
display library/tfl/t-eff-adas-mmrm/display.yaml
custom library/tfl/t-eff-adas-mmrm/custom.R - Current
- v004 · spec 3070e2a · display 2b6b835 · ARD 8953a87
| Iteration | Created | Actor | Change request | Spec | Display | ARD |
|---|---|---|---|---|---|---|
| v001 | 2026-08-27T03:57:31Z | obot worker W0137 | First generation of the MMRM supportive analysis (reference report Table 14-3.11). | 3070e2a | 8569301 | 5300381 |
| v002 | 2026-08-27T03:58:05Z | obot worker W0137 | State in the display footnotes exactly which five cells differ from the reference report, and why: Kenward-Roger degrees of freedom and PRJKH standard errors are not implemented. | 3070e2a | edf5001 | 9df5a53 |
| v003 | 2026-09-02T15:23:22Z | @obotclaw | One study (D0032 R2, #59): regenerated so the ARD carries its population record for the treatment-consistency gate. Spec and lane unchanged; every statistic identical. | 3070e2a | edf5001 | 3f78c39 |
| v004 | 2026-09-02T16:32:01Z | @obotclaw | Footnote records the Kenward-Roger spike (D0032 Issue H, #66): tried with mmrm, reproduces the REML criterion, moves one of the five cells and not the other four; model-based fit kept. Every statistic unchanged. | 3070e2a | 2b6b835 | 8953a87 |
t-eff-npix-mean Mean NPI-X Total Score from Week 4 through Week 24 - Windowed EFT09
- Type
- table
- E3 position
- §14.2
- Files
- analysis library/tfl/t-eff-npix-mean/analysis.yaml
display library/tfl/t-eff-npix-mean/display.yaml
custom library/tfl/t-eff-npix-mean/custom.R - Current
- v003 · spec 80f5f0c · display c321095 · ARD 670210c
| Iteration | Created | Actor | Change request | Spec | Display | ARD |
|---|---|---|---|---|---|---|
| v001 | 2026-08-27T03:49:43Z | obot worker W0137 | First generation of the secondary efficacy endpoint (reference report Table 14-3.12). | 80f5f0c | 2a12528 | 3672359 |
| v002 | 2026-08-27T03:50:45Z | obot worker W0137 | Record in the display's own footnotes that this endpoint is derived from the per-visit NPTOT records rather than the study's NPTOTMN parameter, and what the two differ by. | 80f5f0c | c321095 | 86751a3 |
| v003 | 2026-09-02T15:23:25Z | @obotclaw | One study (D0032 R2, #59): regenerated so the ARD carries its population record for the treatment-consistency gate. Spec and lane unchanged; every statistic identical. | 80f5f0c | c321095 | 670210c |
t-ae-overview Overview of Treatment-Emergent Adverse Events AET01
- Type
- table
- E3 position
- §14.3.1
- Files
- analysis library/tfl/t-ae-overview/analysis.yaml
display library/tfl/t-ae-overview/display.yaml
custom library/tfl/t-ae-overview/custom.R - Current
- v003 · spec 6b0ba69 · display ea18faf · ARD c428956
| Iteration | Created | Actor | Change request | Spec | Display | ARD |
|---|---|---|---|---|---|---|
| v001 | 2026-07-25T06:39:08Z | @jwildfire | Initial generation of AET01 from the statistical analysis plan shell. | 6b0ba69 | 0452044 | 8c7cee6 |
| v002 | 2026-07-27T03:23:34Z | @obotclaw | Add submission-format RTF artifacts to every variant (obot.roadmap #129 A). | 6b0ba69 | 0452044 | 96f9dbf |
| v003 | 2026-09-02T15:19:13Z | @obotclaw | One study (D0032 R2, #60): read the CDISC pilot own ADaM package, which assigns every subject the arm the rest of the report uses. Spec unchanged; lane changed. | 6b0ba69 | ea18faf | c428956 |
t-ae-common Treatment-Emergent Adverse Events by System Organ Class and Preferred Term AET02
- Type
- table
- E3 position
- §14.3.1
- Files
- analysis library/tfl/t-ae-common/analysis.yaml
display library/tfl/t-ae-common/display.yaml - Current
- v004 · spec a45e3a1 · display 3027c71 · ARD adf6d63
| Iteration | Created | Actor | Change request | Spec | Display | ARD |
|---|---|---|---|---|---|---|
| v001 | 2026-07-25T06:39:08Z | @jwildfire | Initial generation of AET02 from the statistical analysis plan shell: treatment-emergent adverse events by system organ class and preferred term, with a 5% threshold on the in-text variant. | 750a0b3 | dc5fa1c | e62a942 |
| v002 | 2026-07-25T06:39:10Z | @medical-writer | Change request CR-001 (medical writer, Section 12.2.1 review): add an All Subjects (Total) column to AET02 so the in-text summary can quote a pooled overall rate alongside the by-arm rates. Applied as a spec edit - analysis.yaml `total: false` -> `true`, display.yaml `columns.order` gains Total - and regenerated; no output was hand-edited. | a45e3a1 | c749510 | ed1716a |
| v003 | 2026-07-27T03:23:32Z | @obotclaw | Add submission-format RTF artifacts to every variant (obot.roadmap #129 A). | a45e3a1 | c749510 | 5f250be |
| v004 | 2026-09-02T15:19:14Z | @obotclaw | One study (D0032 R2, #60): read the CDISC pilot own ADaM package, which assigns every subject the arm the rest of the report uses. Spec unchanged; lane changed. | a45e3a1 | 3027c71 | adf6d63 |
t-exposure Extent of Exposure to Study Drug EXT01
- Type
- table
- E3 position
- §14.3.1
- Files
- analysis library/tfl/t-exposure/analysis.yaml
display library/tfl/t-exposure/display.yaml - Current
- v004 · spec 065027f · display d4dbe63 · ARD de9e7ac
| Iteration | Created | Actor | Change request | Spec | Display | ARD |
|---|---|---|---|---|---|---|
| v001 | 2026-07-25T06:39:07Z | @jwildfire | Initial generation of EXT01 from the statistical analysis plan shell. | dcb569b | 5cf918a | f6624be |
| v002 | 2026-07-27T03:23:36Z | @obotclaw | Add submission-format RTF artifacts to every variant (obot.roadmap #129 A). | dcb569b | 5cf918a | f14f5e3 |
| v003 | 2026-09-02T15:19:12Z | @obotclaw | One study (D0032 R2, #60): rebuilt from ADSL AVGDD and CUMDOSE for the safety population and the Week 24 completers, as Table 14-4.01 of the reference report summarises them. No exposure dataset is read. | a9667a1 | e8dbf5c | c110b87 |
| v004 | 2026-09-02T15:23:19Z | @obotclaw | One study (D0032 R2, #60): rebuilt from ADSL AVGDD and CUMDOSE for the safety population and the Week 24 completers, as Table 14-4.01 of the reference report summarises them; duration of treatment (TRTDUR) and the exposure categories kept for the Section 12.1 narrative under their existing binding names. No exposure dataset is read. | 065027f | d4dbe63 | de9e7ac |
l-ae-serious Listing of Serious Adverse Events AEL01
- Type
- listing
- E3 position
- §14.3.2
- Files
- analysis library/tfl/l-ae-serious/analysis.yaml
display library/tfl/l-ae-serious/display.yaml - Current
- v003 · spec a046fb1 · display 11a00d0 · ARD cde8256
| Iteration | Created | Actor | Change request | Spec | Display | ARD |
|---|---|---|---|---|---|---|
| v001 | 2026-07-25T06:39:08Z | @jwildfire | Initial generation of AEL01 from the statistical analysis plan shell. | a046fb1 | b865356 | f3a6c72 |
| v002 | 2026-07-27T03:23:31Z | @obotclaw | Add submission-format RTF artifacts to every variant (obot.roadmap #129 A). | a046fb1 | b865356 | 0395149 |
| v003 | 2026-09-02T15:19:13Z | @obotclaw | One study (D0032 R2, #60): read the CDISC pilot own ADaM package, which assigns every subject the arm the rest of the report uses. Spec unchanged; lane changed. | a046fb1 | 11a00d0 | cde8256 |
t-conmeds Summary of Concomitant Medications CMT01
- Type
- table
- E3 position
- §14.3.5
- Files
- analysis library/tfl/t-conmeds/analysis.yaml
display library/tfl/t-conmeds/display.yaml - Current
- v003 · spec 5b8045e · display a79342e · ARD 95799f7
| Iteration | Created | Actor | Change request | Spec | Display | ARD |
|---|---|---|---|---|---|---|
| v001 | 2026-08-27T04:06:04Z | @jwildfire | Initial generation of CMT01, targeting Table 14-7.04 of the reference clinical study report for this study. | 5b8045e | 6f1a46f | 87b879c |
| v002 | 2026-09-02T15:19:45Z | @obotclaw | One study (D0032 R2, #60): read the CDISC pilot own ADaM package, which assigns every subject the arm the rest of the report uses. Spec unchanged; lane changed. | 5b8045e | a79342e | f548b4f |
| v003 | 2026-09-02T16:21:44Z | @obotclaw | Concomitant medications derived from the study own SDTM CM domain (D0032, #65): every statistic identical to the relabelled PHUSE copy it replaces, which stays vendored for the check that proves it. | 5b8045e | a79342e | 95799f7 |
t-vitals Summary of Vital Signs at Baseline and End of Treatment VST01
- Type
- table
- E3 position
- §14.3.5
- Files
- analysis library/tfl/t-vitals/analysis.yaml
display library/tfl/t-vitals/display.yaml - Current
- v002 · spec 2aeb258 · display eb31735 · ARD 80334ea
| Iteration | Created | Actor | Change request | Spec | Display | ARD |
|---|---|---|---|---|---|---|
| v001 | 2026-08-27T04:06:01Z | @jwildfire | Initial generation of VST01, targeting Table 14-7.01 of the reference clinical study report for this study. | 2aeb258 | faa409a | 88e8ee0 |
| v002 | 2026-09-02T15:19:43Z | @obotclaw | One study (D0032 R2, #60): read the CDISC pilot own ADaM package, which assigns every subject the arm the rest of the report uses. Spec unchanged; lane changed. | 2aeb258 | eb31735 | 80334ea |
t-vitals-change Summary of Vital Signs Change from Baseline at End of Treatment VST02
- Type
- table
- E3 position
- §14.3.5
- Files
- analysis library/tfl/t-vitals-change/analysis.yaml
display library/tfl/t-vitals-change/display.yaml - Current
- v002 · spec 0d204e9 · display 840b226 · ARD 4a0f857
| Iteration | Created | Actor | Change request | Spec | Display | ARD |
|---|---|---|---|---|---|---|
| v001 | 2026-08-27T04:06:03Z | @jwildfire | Initial generation of VST02, targeting Table 14-7.02 of the reference clinical study report for this study. | 0d204e9 | 590c09c | 2561647 |
| v002 | 2026-09-02T15:19:44Z | @obotclaw | One study (D0032 R2, #60): read the CDISC pilot own ADaM package, which assigns every subject the arm the rest of the report uses. Spec unchanged; lane changed. | 0d204e9 | 840b226 | 4a0f857 |
t-weight Summary of Weight and Weight Change from Baseline at End of Treatment VST03
- Type
- table
- E3 position
- §14.3.5
- Files
- analysis library/tfl/t-weight/analysis.yaml
display library/tfl/t-weight/display.yaml - Current
- v004 · spec 14be68b · display e1621d7 · ARD 39d684c
| Iteration | Created | Actor | Change request | Spec | Display | ARD |
|---|---|---|---|---|---|---|
| v001 | 2026-08-27T04:10:09Z | @w-vitals | Initial generation of VST03, targeting Table 14-7.03 of the reference clinical study report: weight and weight change from baseline at Week 24 and end of treatment. | 14be68b | c1a16fd | ce01673 |
| v002 | 2026-09-02T15:19:45Z | @obotclaw | One study (D0032 R2, #60): read the CDISC pilot own ADaM package, which assigns every subject the arm the rest of the report uses. Spec unchanged; lane changed. | 14be68b | d8f04f8 | 1611911 |
| v003 | 2026-09-02T16:10:30Z | @obotclaw | In-text variant redrawn as the reference report prints it (Tables 11-1, 12-1, 12-4; D0032, #63). | 14be68b | d8f04f8 | 1b3da96 |
| v004 | 2026-09-02T16:11:30Z | @obotclaw | In-text variant redrawn as the reference report prints it (Tables 11-1, 12-1, 12-4; D0032, #63). | 14be68b | e1621d7 | 39d684c |
t-ae-incidence Incidence of Treatment Emergent Adverse Events by Treatment Group AET03
- Type
- table
- E3 position
- §14.3.1
- Files
- analysis library/tfl/t-ae-incidence/analysis.yaml
display library/tfl/t-ae-incidence/display.yaml
custom library/tfl/t-ae-incidence/custom.R - Custom code
- custom code shared with t-sae-incidence
- Current
- v007 · spec a94b85b · display 0511d99 · ARD 091de51
| Iteration | Created | Actor | Change request | Spec | Display | ARD |
|---|---|---|---|---|---|---|
| v001 | 2026-09-02T15:52:27Z | @obotclaw | Table 14-5.01 of the reference report (D0032, #62): subjects, percentages and event counts per system organ class and preferred term, with Fisher exact tests of placebo against each active arm; organ classes alphabetical, terms by high-dose count then name. | a94b85b | 3834d19 | 8e97f64 |
| v002 | 2026-09-02T15:53:49Z | @obotclaw | Event counts printed as integers; serious-events terms ordered as the reference serious-events program orders them (descending subjects across groups, then name). | a94b85b | 607f4ae | 9940015 |
| v003 | 2026-09-02T15:56:53Z | @obotclaw | A p-value under 0.0005 prints as 0.000, as the reference report prints it. | a94b85b | 607f4ae | 3652173 |
| v004 | 2026-09-02T16:01:54Z | @obotclaw | A trailing zero at the third decimal of a p-value is dropped, as the report prints it; the four p-values the reference rounded a thousandth higher are stated in the footnotes. | a94b85b | eec75fe | 129545c |
| v005 | 2026-09-02T16:02:56Z | @obotclaw | A p-value of 0.000 keeps its zeros; only a single trailing zero at the third decimal is dropped, as the report prints. | a94b85b | eec75fe | c8613b3 |
| v006 | 2026-09-02T16:10:29Z | @obotclaw | In-text variant redrawn as the reference report prints it (Tables 11-1, 12-1, 12-4; D0032, #63). | a94b85b | eec75fe | 4ded035 |
| v007 | 2026-09-02T16:11:28Z | @obotclaw | In-text variant redrawn as the reference report prints it (Tables 11-1, 12-1, 12-4; D0032, #63). | a94b85b | 0511d99 | 091de51 |
t-sae-incidence Incidence of Treatment Emergent Serious Adverse Events by Treatment Group AET04
- Type
- table
- E3 position
- §14.3.2
- Files
- analysis library/tfl/t-sae-incidence/analysis.yaml
display library/tfl/t-sae-incidence/display.yaml - Custom code
- borrows t-ae-incidence's custom code
- Current
- v006 · spec 065d87f · display 2e8296c · ARD 94a983c
| Iteration | Created | Actor | Change request | Spec | Display | ARD |
|---|---|---|---|---|---|---|
| v001 | 2026-09-02T15:52:30Z | @obotclaw | Table 14-5.02 of the reference report (D0032, #62): subjects, percentages and event counts per system organ class and preferred term, with Fisher exact tests of placebo against each active arm; organ classes alphabetical, terms by high-dose count then name. | 065d87f | 474d824 | 8a8cacc |
| v002 | 2026-09-02T15:53:51Z | @obotclaw | Event counts printed as integers; serious-events terms ordered as the reference serious-events program orders them (descending subjects across groups, then name). | 065d87f | 194d3e4 | f16e533 |
| v003 | 2026-09-02T15:55:20Z | @obotclaw | Terms ordered by subjects summed across the arms, then name, which is the order the reference serious-events program prints. | 065d87f | 2e8296c | 2d64159 |
| v004 | 2026-09-02T15:56:55Z | @obotclaw | A p-value under 0.0005 prints as 0.000, as the reference report prints it. | 065d87f | 2e8296c | ebb3ef5 |
| v005 | 2026-09-02T16:01:56Z | @obotclaw | A trailing zero at the third decimal of a p-value is dropped, as the report prints it; the four p-values the reference rounded a thousandth higher are stated in the footnotes. | 065d87f | 2e8296c | ab0d387 |
| v006 | 2026-09-02T16:02:57Z | @obotclaw | A p-value of 0.000 keeps its zeros; only a single trailing zero at the third decimal is dropped, as the report prints. | 065d87f | 2e8296c | 94a983c |
t-subjects-by-site Summary of Number of Subjects By Site DST04
- Type
- table
- E3 position
- §14.1
- Files
- analysis library/tfl/t-subjects-by-site/analysis.yaml
display library/tfl/t-subjects-by-site/display.yaml - Current
- v002 · spec 9b145f6 · display 3087fc5 · ARD 6887f57
| Iteration | Created | Actor | Change request | Spec | Display | ARD |
|---|---|---|---|---|---|---|
| v001 | 2026-09-02T16:10:26Z | @obotclaw | Table 14-1.03 of the reference report (D0032, #63): intent-to-treat, efficacy and Week 24 completer counts per site and arm, small sites pooled under 900, twelve columns of arm by population. | 9b145f6 | 3087fc5 | 77ce981 |
| v002 | 2026-09-02T16:15:18Z | @obotclaw | Site carried as a factor over every site, so a site with no subjects in a population prints 0 rather than nothing. | 9b145f6 | 3087fc5 | 6887f57 |
f-disposition Subject Disposition DSF01
- Type
- figure
- E3 position
- §10.1
- Files
- analysis library/tfl/f-disposition/analysis.yaml
display library/tfl/f-disposition/display.yaml
custom library/tfl/f-disposition/custom.R - Current
- v001 · spec abf4fa1 · display 334133a · ARD 700d5e7
| Iteration | Created | Actor | Change request | Spec | Display | ARD |
|---|---|---|---|---|---|---|
| v001 | 2026-09-02T16:24:32Z | @obotclaw | Figure 10-1 of the reference report (D0032, #63): subjects screened, screen failures, randomised, completed Week 24 and completed the study, as a flow from the study SDTM DM and ADSL. | abf4fa1 | 334133a | 700d5e7 |
Value declarations
library/values/values.yaml: a number the report reuses, named once. The store the pipeline resolves from it is the Values view.
| Id | Label | Kind | Declaration | Format |
|---|---|---|---|---|
| randomised-n | Subjects randomised | ARD | t-disposition:randomised:n;group=Total | digits 0 |
| treated-n | Subjects treated (safety analysis set) | ARD | t-disposition:treated:n;group=Total | digits 0 |
| completed-n | Subjects who completed the study | ARD | t-disposition:completed:n;group=Total | digits 0 |
| discontinued-n | Subjects who discontinued | ARD | t-disposition:discontinued:n;group=Total | digits 0 |
| completed-pct | Percentage of randomised subjects who completed | ARD | t-disposition:completed:p;group=Total | scale 100, digits 1 |
| age-median-total | Median age (years), all subjects | ARD | t-demographics:age:median;group=Total | digits 1 |
| female-n-total | Female subjects | ARD | t-demographics:sex:n;group=Total;variable_level=F | digits 0 |
| ae-any-n-total | Subjects with at least one adverse event | ARD | t-ae-overview:any_ae:n;group=Total | digits 0 |
| ae-any-n-placebo | Subjects with at least one adverse event (Placebo) | ARD | t-ae-overview:any_ae:n;group=Placebo | digits 0 |
| ae-any-n-low | Subjects with at least one adverse event (Xanomeline Low Dose) | ARD | t-ae-overview:any_ae:n;group=Xanomeline Low Dose | digits 0 |
| ae-any-n-high | Subjects with at least one adverse event (Xanomeline High Dose) | ARD | t-ae-overview:any_ae:n;group=Xanomeline High Dose | digits 0 |
| ae-any-pct-high | Percentage of high-dose subjects with at least one adverse event | ARD | t-ae-overview:any_ae:p;group=Xanomeline High Dose | scale 100, digits 1 |
| safety-n-high | Subjects in the safety analysis set (Xanomeline High Dose) | ARD | t-ae-overview:any_ae:N;group=Xanomeline High Dose | digits 0 |
| ae-any-n-xanomeline | Subjects with at least one adverse event, both xanomeline arms | derived | sum(ae-any-n-low, ae-any-n-high) | digits 0 |
| ae-excess-high-vs-placebo | Additional subjects with an adverse event, high dose versus placebo | derived | difference(ae-any-n-high, ae-any-n-placebo) | digits 0 |