Post-Text Display Package · template

Report Template Library

Post-Text Display Package as data

ICH E3 has been unrevised since 1995 and no machine-readable model of it existed publicly; ICH M11 did this for protocols in November 2025. library/templates/display-package/sections.yaml encodes this document's 11-entry skeleton — number, title, slug and content model. assembly.yaml says what this report puts in it. Display numbers appear in neither: the assembler derives them from assembly order, so reordering the report is a one-line diff and a display's identity never changes (design D6). The library is plural — the same two files describe every document open.csr assembles.

11sections modelledthe whole skeleton, filled or not

5populated in this demoevery other section renders as a marked gap

30displays numberedassigned at assembly, not authored

0assembly slots configuredtext blocks and in-text displays

Section 16.1.9 is generated, not written: package versions, ARD hashes, data manifests and session info are emitted mechanically. E3 reserved that slot in 1995 and open.csr fills it from the build.

Assigned numbering

Derived from assembly.yaml post_text order at build time. The slug is what the specs, the ARDs and the bindings all refer to — reorder the report and every number here moves while no spec, ARD or sentence changes at all.

Number	Display	Slug	Section
Table 14.1.1	Subject Disposition	t-disposition	14.1
Table 14.1.2	Demographic and Baseline Characteristics	t-demographics	14.1
Table 14.1.3	Summary of Populations	t-populations	14.1
Table 14.1.4	Summary of End of Study Data	t-end-of-study	14.1
Table 14.1.5	Summary of Number of Subjects By Site	t-subjects-by-site	14.1
Figure 14.1.6	Subject Disposition	f-disposition	14.1
Table 14.2.1	Primary Endpoint Analysis: ADAS-Cog (11) - Change from Baseline to Week 24 - LOCF	t-eff-adas-wk24	14.2
Table 14.2.2	Primary Endpoint Analysis: CIBIC+ — Summary at Week 24 — LOCF	t-cibic-week24	14.2
Table 14.2.3	ADAS-Cog (11) - Change from Baseline to Week 8 - LOCF	t-eff-adas-wk8	14.2
Table 14.2.4	CIBIC+ — Summary at Week 8 — LOCF	t-cibic-week8	14.2
Table 14.2.5	ADAS-Cog (11) - Change from Baseline to Week 16 - LOCF	t-eff-adas-wk16	14.2
Table 14.2.6	CIBIC+ — Summary at Week 16 — LOCF	t-cibic-week16	14.2
Table 14.2.7	ADAS-Cog (11) - Change from Baseline to Week 24 - Completers at Week 24, Observed Cases, Windowed	t-eff-adas-wk24-completers	14.2
Table 14.2.8	ADAS-Cog (11) - Change from Baseline to Week 24 in Male Subjects - LOCF	t-eff-adas-wk24-male	14.2
Table 14.2.9	ADAS-Cog (11) - Change from Baseline to Week 24 in Female Subjects - LOCF	t-eff-adas-wk24-female	14.2
Table 14.2.10	ADAS-Cog (11) - Mean and Mean Change from Baseline over Time	t-eff-adas-overtime	14.2
Table 14.2.11	ADAS-Cog (11) - Repeated Measures Analysis of Change from Baseline to Week 24	t-eff-adas-mmrm	14.2
Table 14.2.12	Mean NPI-X Total Score from Week 4 through Week 24 - Windowed	t-eff-npix-mean	14.2
Table 14.2.13	CIBIC+ — Categorical Analysis — LOCF	t-cibic-categorical	14.2
Figure 14.2.14	Time to Dermatologic Event by Treatment Group	f-derm-time-to-event	14.2
Table 14.3.1.1	Extent of Exposure to Study Drug	t-exposure	14.3.1
Table 14.3.1.2	Overview of Treatment-Emergent Adverse Events	t-ae-overview	14.3.1
Table 14.3.1.3	Treatment-Emergent Adverse Events by System Organ Class and Preferred Term	t-ae-common	14.3.1
Table 14.3.1.4	Incidence of Treatment Emergent Adverse Events by Treatment Group	t-ae-incidence	14.3.1
Listing 14.3.2.1	Listing of Serious Adverse Events	l-ae-serious	14.3.2
Table 14.3.2.2	Incidence of Treatment Emergent Serious Adverse Events by Treatment Group	t-sae-incidence	14.3.2
Table 14.3.5.1	Summary of Vital Signs at Baseline and End of Treatment	t-vitals	14.3.5
Table 14.3.5.2	Summary of Vital Signs Change from Baseline at End of Treatment	t-vitals-change	14.3.5
Table 14.3.5.3	Summary of Weight and Weight Change from Baseline at End of Treatment	t-weight	14.3.5
Table 14.3.5.4	Summary of Concomitant Medications	t-conmeds	14.3.5

The document skeleton

All 11 modelled sections, and what this report puts in each. Sections marked not in this demo still assemble, as headings that say so — the skeleton stays visible rather than being trimmed to what happens to be built.

§	Title	Content model	Text	Displays	State
14	Tables, Figures and Graphs Referred to but not Included in the Text	post text index	—	—	not in this demo
14.1	Demographic Data	post text index	—	Table 14.1.1 Table 14.1.2 Table 14.1.3 Table 14.1.4 Table 14.1.5 Figure 14.1.6	populated
14.2	Efficacy Data	post text index	—	Table 14.2.1 Table 14.2.2 Table 14.2.3 Table 14.2.4 Table 14.2.5 Table 14.2.6 Table 14.2.7 Table 14.2.8 Table 14.2.9 Table 14.2.10 Table 14.2.11 Table 14.2.12 Table 14.2.13 Figure 14.2.14	populated
14.3	Safety Data	—	—	—	not in this demo
14.3.1	Displays of Adverse Events	post text index	—	Table 14.3.1.1 Table 14.3.1.2 Table 14.3.1.3 Table 14.3.1.4	populated
14.3.2	Listings of Deaths, Other Serious and Significant Adverse Events	post text index	—	Listing 14.3.2.1 Table 14.3.2.2	populated
14.3.4	Abnormal Laboratory Value Listing (Each Patient)	post text index	—	—	not in this demo
14.3.5	Displays of Vital Signs, Weight and Concomitant Medications	post text index	—	Table 14.3.5.1 Table 14.3.5.2 Table 14.3.5.3 Table 14.3.5.4	populated
16	Appendices	—	—	—	not in this demo
16.1	Study Information	—	—	—	not in this demo
16.1.9	Documentation of Statistical Methods	text generated provenance	—	—	not in this demo