Grade 3/4/5 toxicities from the E1609 trial and EORTC trial. These studies are in the setting of resected patients (adjuvant)

E1609 triala (Safety Data n = 1019)(Total Enrollment = 1673)EORTC 18071 trial (n = 945)
Treatment typeIpi 3 mg/kgIpi 10 mg/kgIpi 10 mg/kgPlacebo
Number of patients516503471474
Adverse event of any grade98.4%100%(465 99%)432 (91%)
Treatment-related AE (any grade)96%98.8%
 Grade 3 adverse eventsb37%57%
 Grade 4 adverse eventsb
Immune related adverse events (grade 3/4)18.8%34%196 (41.6%)13 (2.7%)
 Gastrointestinal adverse eventb12.0%18.5%76 (16%)4 (< 1%)
 Hepatic adverse eventsb3.1%7.8%51 (11%)1 (< 1%)
 Endocrine adverse eventsb6.6%12.4%37 (8%)1(< 1%)
 Neurologic adverse eventsb2.0%1.6%9 (1.9%)0 (0%)
Treatment related Adverse event leading to discontinuation of treatment35%54%240 (51%)22(4.6%)
Death due to treatment related adverse events2 (0.4%)8 (1.6%)5 (1.1%)0

aAbstract available only for the E1609 trial

bGrade 3/4 adverse events