Table. Adverse Events During Nivo + Ipi and PD-1 Monotherapy.
| Immune-Related Adverse Events | No. (%) | |||||||
|---|---|---|---|---|---|---|---|---|
| Nivo + Ipi | Anti–PD-1 Monotherapy | Total Across Nivo + Ipi and PD-1 Monotherapy | ||||||
| Grade | Immune-Related AEs Associated With Nivo + Ipi Dose Delays | Grade | Total | Immune-Related AEs Requiring Steroid Treatment | ||||
| 1 | 2 | 3 or 4 | 2 | 3 or 4 | ||||
| Asymptomatic lipase/amylase | 0 | 4 (6) | 17 (27) | 11 of 21 (52) | 0 | 7 (11) | 28 (44) | 6 (9) |
| Diarrhea/colitis | 3 (5) | 9 (14) | 13 (20) | 20 of 25 (80) | 3 (5) | 0 | 28 (42) | 20 (31) |
| Endocrinopathy | 1 (2) | 12 (19) | 5 (8) | 4 of 18 (22) | 6 (9) | 3 (5) | 27 (42) | 10 (16) |
| Hypothyroidism | 1 (2) | 8 (13) | 0 | 2 of 9 (22) | 3 (5) | 0 | 12 (19) | 1 (2) |
| Hypophysitis | 0 | 4 (6) | 2 (3) | 2 of 6 (33) | 2 (3) | 0 | 8 (13) | 8 (13) |
| Hyperglycemia | 0 | 0 | 3 (5) | 0 of 3 (0) | 1 (2) | 3 (5) | 7 (11) | 1 (2) |
| Rash/pruritus | 1 (2) | 12 (19) | 5 (8) | 11 of 18 (61) | 2 (3) | 0 | 19 (30) | 10 (16) |
| Transaminitis | 1 (2) | 6 (9) | 10 (16) | 15 of 17 (88) | 1 (2) | 1 (2) | 19 (30) | 17 (27) |
| Fatigue | 0 | 11 (17) | 0 | 2 of 11 (18) | 0 | 0 | 11 (17) | 1 (2) |
| Pneumonitis | 0 | 6 (9) | 1 (2) | 7 of 7 (100) | 1 (2) | 0 | 8 (13) | 8 (13) |
| Pancreatitis | 0 | 0 | 1 (2) | 1 of 1 (100) | 2 (3) | 1 (2) | 4 (6) | 4 (6) |
Abbreviations: AEs, adverse events; nivo + ipi, nivolumab plus ipilimumab; PD-1, programmed cell death protein 1.