E1609 triala (Safety Data n = 1019)(Total Enrollment = 1673) | EORTC 18071 trial (n = 945) | |||
---|---|---|---|---|
Treatment type | Ipi 3 mg/kg | Ipi 10 mg/kg | Ipi 10 mg/kg | Placebo |
Number of patients | 516 | 503 | 471 | 474 |
Adverse event of any grade | 98.4% | 100% | (465 99%) | 432 (91%) |
Treatment-related AE (any grade) | 96% | 98.8% | ||
Grade 3 adverse eventsb | 37% | 57% | ||
Grade 4 adverse eventsb | ||||
Immune related adverse events (grade 3/4) | 18.8% | 34% | 196 (41.6%) | 13 (2.7%) |
Gastrointestinal adverse eventb | 12.0% | 18.5% | 76 (16%) | 4 (< 1%) |
Hepatic adverse eventsb | 3.1% | 7.8% | 51 (11%) | 1 (< 1%) |
Endocrine adverse eventsb | 6.6% | 12.4% | 37 (8%) | 1(< 1%) |
Neurologic adverse eventsb | 2.0% | 1.6% | 9 (1.9%) | 0 (0%) |
Treatment related Adverse event leading to discontinuation of treatment | 35% | 54% | 240 (51%) | 22(4.6%) |
Death due to treatment related adverse events | 2 (0.4%) | 8 (1.6%) | 5 (1.1%) | 0 |
aAbstract available only for the E1609 trial
bGrade 3/4 adverse events