Post-authorisation safety study: lumevarin hepatic safety in routine practice

EVP-0007Post-authorisation studyLumevaData collectionRisk lowSponsor: Company

NPDr. Nikolai PetrovHead of Evidence Generation & HEOR

Evidence gap: Long-term hepatic safety
Objective: No objective link (DQ rule: strategic linkage)
Research question: What is the incidence of hepatic adverse events in routine use over 3 years?
Design: Prospective PASS per EMA commitment
Investigator: —
Institution: —
Countries: Germany, United Kingdom, France, Italy, Spain
Data source: Prospective
Submitted: 01 Sept 2023
Approved: 15 Nov 2023 (75 days)
Contract / ethics: ExecutedEthics approved
Budget / spend: $1.2M of $1.8M
69%
Enrolment: 2,410 of 3,000
80%

Workflow

Evidence-generation workflow (PRD §17); Rejected is a terminal branch from any review stage.

Current stageData collectionDemo action — not persisted

Review stages passed, derived from workflow position

Study milestones from CTMS (INT-06)

Milestone	Due	Completed	Status	Evidence / note	Late days
Interim report 2	30 Jun 2026	28 Jun 2026	Completed	Evidence missing	-2
Last patient in	31 Dec 2026	—	In progress	—	0

No linked publications

Insights citing the evidence gap "Long-term hepatic safety"

No linked insights

No related risks

No dependencies recorded

No audit events for this record

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