Table 1 Grade 3/4/5 toxicities from the E1609 trial and EORTC trial. These studies are in the setting of resected patients (adjuvant)

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 events^b

 Grade 4 adverse events^b

Immune related adverse events (grade 3/4)

18.8%

34%

196 (41.6%)

13 (2.7%)

 Gastrointestinal adverse event^b

12.0%

18.5%

76 (16%)

4 (< 1%)

 Hepatic adverse events^b

3.1%

7.8%

51 (11%)

1 (< 1%)

 Endocrine adverse events^b

6.6%

12.4%

37 (8%)

1(< 1%)

 Neurologic adverse events^b

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