Table 2.

Overview of treatment-emergent adverse events in the overall period (SAF)

	Total (N = 843) n (%)
All TEAEs	796 (94.4)
Drug-relateda TEAEs,	656 (77.8)
≥ Grade 3 TEAEb	266 (31.6)
All SAEs	199 (23.6)
Drug-relateda SAEs	113 (13.4)
TEAEs leading to permanent discontinuation of study drug
All	140 (16.6)
Drug-relateda	92 (10.9)
SAEs	75 (8.9)
Drug-relateda SAEs	50 (5.9)
Deathsc	2 (0.2)

TEAEs 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

AE adverse event, SAE serious adverse event, SAF safety analysis set, TEAE treatment-emergent adverse event

^aPossibly or probably related to study drug, as assessed by the investigator or records where relationship was missing

^bNational 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

^cOne death during the study due to diffuse large B-cell lymphoma was considered probably related to the study drug. One death during the study due to pneumonia and one death after the end of the study due to uterine sarcoma were considered possibly related to the study drug