Module 2.7.6 — Synopses of Individual Studies (OBX-319)
📚 Part of the OBX-319 Regulatory Dossier — Reader's Guide. This article shows the live document; edits to the source appear here automatically.
This is a mock / simulation document, made for a portfolio and for learning. The drug (GLPI-103), the sponsor, the people, and the data are all fictional. It is not a real regulatory submission and has no clinical, legal, or regulatory standing. What is real is the shape of the thing — the document structure, the standards it follows, and the analysis methods; the content inside is illustrative.
What it is. Module 2.7.6 — Synopses of Individual Studies (OBX-319)
Why it exists. A high-level CTD summary a reviewer reads first; it distils the underlying reports.
How it is produced here. It contains no new data. It is a distillation — it gathers, summarizes, and cross-references the underlying study reports and datasets into the shorter form a regulator reads first.
Format & governing standard. —
Module 2.7.6 — Synopses of Individual Studies (OBX-319)
Document ID: M276
Version: 1.0
Change History: 1.0 — Initial issue.
Standard(s): ICH M4E(R2)
2.7.6 Synopses of Individual Studies — OBX-319
Structured synopses of each study in the OBX-319 programme. The pivotal study OBX319-301 (randomized, double-blind, placebo-controlled, Phase 3) is summarised below; full synopses appear in the corresponding Module 5 study reports.
| Arm | N | LS-mean Δ SLEDAI-2K @ Wk 52 (points) | Diff vs placebo (95% CI) | p |
|---|---|---|---|---|
| OBX-319 High | 162 | -6.37 | -2.91 (-3.12, -2.69) | 0.0000 |
| OBX-319 Low | 158 | -5.62 | -2.17 (-2.38, -1.95) | 0.0000 |
| Placebo | 160 | -3.46 | — (reference) | — |
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