Table 3.
Drug-related AEs that occurred in ⩾2% of patients enrolled in the KEYNOTE-001, 010 and 024 studies.
| AEs | KEYNOTE-001 n = 495 pts |
KEYNOTE-010 n = 682 pts |
KEYNOTE-024 n = 154 pts |
|||
|---|---|---|---|---|---|---|
| Any grade (%) | Grade 3–5 (%) | Any grade (%) | Grade 3–5 (%) | Any grade (%) | Grade 3–5 (%) | |
| Fatigue | 96 (19.4) | 4 (0.8) | 95 (13.9) | 10 (1.4) | 16 (10.4) | 2 (1.3) |
| Pruritus | 53 (10.7) | 0 | 57 (8.3) | 0 | – | – |
| Decreased appetite | 52 (10.5) | 5 (1.0) | 79 (11.5) | 4 (0.5) | 14 (9.1) | 0 |
| Rash | 67 (13.5) | 1 (0.2) | 87 (12.7) | 3 (0.4) | 6 (3.9) | 6 (3.9) |
| Arthralgia | 45 (9.1) | 2 (0.4) | 32 (4.7) | 2 (0.3) | – | – |
| Diarrhea | 40 (8.1) | 3 (0.6) | 46 (6.7) | 2 (0.3) | 22 (14.3) | 6 (3.9) |
| Nausea | 37 (7.5) | 4 (0.8) | 68 (9.9) | 3 (0.4) | 15 (9.7) | 0 |
| Hypothyroidism | 34 (6.9) | 1 (0.2) | 48 (7.0) | 0 | 14 (9.1) | 0 |
| AST/ALT increased | 26 (5.2) | 5 (1.0) | 41 (6.0) | 5 (0.7) | – | – |
| Asthenia | 24 (4.8) | 5 (1.0) | 39 (5.7) | 3 (0.4) | – | – |
| Anemia | 21 (4.2) | 0 | 24 (3.5) | 4 (0.5) | 8 (5.2) | 3 (1.9) |
| Dyspnoea | 21 (4.2) | 19 (3.8) | 21 (3.0) | 4 (0.5) | – | – |
| Pyrexia | 21 (4.2) | 3 (0.6) | 24 (3.5) | 1 (0.1) | 16 (10.4) | 0 |
| Weight decreased | 19 (3.8) | 2 (0.4) | 15 (2.1) | 1 (0.1) | – | – |
| Dry skin | 18 (3.6) | 0 | 18 (2.6) | 0 | – | – |
| Pneumonitis | 18 (3.6) | 9 (1.8) | 26 (3.8) | 12 (1.7) | 9 (5.8) | 4 (2.6) |
| Vomiting | 14 (2.8) | 3 (0.6) | 25 (3.6) | 1 (0.1) | 4 (2.6) | 1 (0.6) |
| Myalgia | 13 (2.6) | 0 | 19 (2.7) | 0 | 3 (1.9) | 0 |
| Constipation | 10 (2.0) | 2 (0.4) | 23 (3.3) | 0 | 6 (3.9) | 0 |
AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase.