| | Total (N = 843) n (%) |
|---|
All TEAEs | 757 (89.8) |
Drug-related1 TEAEs | 586 (69.5) |
Drug-related1 SAEs | 76 (9.0) |
≥ Grade 3 TEAE2 | 189 (22.4) |
TEAEs leading to permanent discontinuation of study drug |
All | 87 (10.3) |
Drug-related1 | 55 (6.5) |
SAEs | 50 (5.9) |
Drug-related1 SAEs | 30 (3.6) |
- Treatment-emergent adverse events were defined as any AE that started or worsened in severity after initial dose of study drug in the extension study until the end of the final observation
- 1Possibly or probably related to study drug, as assessed by the investigator or records where relationship was missing
- 2National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE): grade 3, severe or medically significant; grade 4, life-threatening; grade 5, death related to AE
- AE adverse event, SAE serious adverse event, SAF safety analysis set
