ROSETTA
10 evidence topics · 4 sources
Objective
Prolonged-effectiveness subgroup objective
Location and study date
Treatment initiation period
Study design
Retrospective multicenter design
Eligibility criteria
Treatment
Tirabrutinib treatment
Study outcomes
Rationale for using overall response rate as an effectiveness endpoint
Endpoint rationale
No evidence found.
Statistical analysis description
Number of participants (Planned and analyzed)
Corrected real-world progression-free survival population
Description of analysis sets
Results
Participant disposition
No evidence found.
Baseline characteristics
Efficacy results
Original interim response and progression-free survival
Corrected real-world progression-free survival figure
Health-related quality of life and patient-reported outcomes
No evidence found.
Safety results
Study limitations
Summary
ROSETTA is a retrospective multicenter study without a randomized comparator. The original interim abstract describes 161 participants, whereas the corrected real-world progression-free survival figure identifies 158. The original median progression-free survival estimate of 11.8 months and the corrected estimate of 11.6 months are retained separately; their populations and analysis versions should not be treated as interchangeable.