DSMB Meeting Minutes (Summary) — GLPI103-301
| Field | Value |
|---|---|
| Document ID | TMF-DSMB-MIN |
| Study No. | GLPI103-301 |
| Standard | per DSMB Charter (TMF-DSMB) |
| Confidentiality | Confidential — TMF (closed-session content restricted) |
Illustrative
[MOCK]open-session summaries of DSMB safety reviews. Safety figures are consistent with the final dataset (CSR-301 §12;outputs/). Closed-session unblinded detail is restricted.
Change History
| Version | Date | Author | Summary |
|---|---|---|---|
| 1.0 | 2026-06-29 | DSMB Secretariat | Initial minutes summary |
Meeting 0 — Organizational [MOCK]
Reviewed and adopted the Charter; confirmed independence/quorum; agreed data presentation format, AESI definitions, and meeting milestones (~25/50/75% enrolled).
Meeting 1 — Safety Review (≈25% enrolled) [MOCK]
- Data reviewed: disposition, TEAEs by arm, AESIs, SAEs, hypoglycaemia, labs.
- Findings: gastrointestinal AEs predominant and as expected for the class; isolated serious events reviewed, none treatment-related; no pancreatitis or thyroid events; hypoglycaemia infrequent.
- Recommendation: CONTINUE without modification.
Meeting 2 — Safety Review (≈50% enrolled) [MOCK]
- Gastrointestinal AEs as expected for the class and broadly balanced across arms; predominantly mild–moderate; manageable with titration; discontinuations within expected range.
- No new safety signal; cardiovascular/heart-rate parameters unremarkable.
- Recommendation: CONTINUE; reinforce titration guidance in site communications.
Meeting 3 — Safety Review (≈75% enrolled) [MOCK]
- Cumulative safety consistent with the class profile; serious events reviewed, none treatment-related; AESIs stable.
- Recommendation: CONTINUE to completion.
Final-database safety (CSR-301): Any TEAE 67.1/67.7/72.2%; nausea IV 32.3% vs sema 21.4% (ns); 10 serious adverse events and 2 deaths (none treatment-related) — consistent with the DSMB's interim assessments.