Table 3:
Immune-related adverse events by dose and grade
| 1 mg/kg (n=3) |
3 mg/kg (n=6) |
5 mg/kg (n=6) |
10 mg/kg (n=15) |
Total (n=30) |
|||||
|---|---|---|---|---|---|---|---|---|---|
| Grade 2 | Grade 3 | Grade 2 | Grade 3/4 | Grade 2 | Grade 3 | Grade 2 | Grade 3/4 | Grade 2–4 | |
| Diarrhoea or colitis | 0 | 0 | 1 | 1 (grade 3) | 1 | 1 | 2 | 2 (1 grade 3 plus 1 grade 4) | 8 |
| Rash | 0 | 0 | 1 | 0 | 1 | 0 | 6 | 2 (grade 3) | 10 |
| Panhypophysitis | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 1 (grade 3) | 4 |
| Hypothyroidism | 0 | 0 | 0 | 0 | 2 | 0 | 2 | 0 | 4 |
| Adrenal insufficiency | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 (grade 3) | 3 |
| Raised aminotransferases | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 (grade 3) | 3 |
| Neutropenia | 0 | 0 | 0 | 1 (grade 4) | 1 | 0 | 0 | 0 | 2 |
| Total (proportion of ipilimumab cycles) | 0 (0%) | 0 (0%) | 2 (14%) | 2 (14%) | 7 (41%) | 2 (12%) | 13 (28%) | 8 (18%) | ·· |
| Total for grades 2–4 (proportion of ipilimumab cycles | ·· | 0 (0%) | ·· | 4 (28%) | ·· | 9 (53%) | ·· | 21 (46%) | 34 (40%) |
Data are number of events; some patients had more than one event.