Table 3.
TEAEs reported in ≥5% of patients by MedDRA preferred term (safety assessable population)
| Preferred term, n (%) | Melanoma (n = 35) |
NSCLC (n = 23) |
UC (n = 29) |
RCC (n = 34) |
Total (N = 121) |
|||||
|---|---|---|---|---|---|---|---|---|---|---|
| All grades | Grade ≥3 | All grades | Grade ≥3 | All grades | Grade ≥3 | All grades | Grade ≥3 | All grades | Grade ≥3 | |
| Any TEAE | 31 (88.6) | 13 (37.1) | 19 (82.6) | 12 (52.2) | 28 (96.6) | 15 (51.7) | 32 (94.1) | 13 (38.2) | 110 (90.9) | 53 (43.8) |
| Asthenia | 7 (20.0) | 0 | 3 (13.0) | 1 (4.3) | 8 (27.6) | 0 | 6 (17.6) | 1 (2.9) | 24 (19.8) | 2 (1.7) |
| Arthralgia | 8 (22.9) | 0 | 0 | 0 | 8 (27.6) | 0 | 6 (17.6) | 2 (5.9) | 22 (18.2) | 2 (1.7) |
| Pruritus | 8 (22.9) | 0 | 3 (13.0) | 0 | 4 (13.8) | 0 | 5 (14.7) | 0 | 20 (16.5) | 0 |
| Decreased appetite | 4 (11.4) | 0 | 5 (21.7) | 1 (4.3) | 7 (24.1) | 0 | 3 (8.8) | 0 | 19 (15.7) | 1 (0.8) |
| Diarrhea | 6 (17.1) | 0 | 3 (13.0) | 1 (4.3) | 4 (13.8) | 0 | 3 (8.8) | 0 | 16 (13.2) | 1 (0.8) |
| Anemia | 1 (2.9) | 1 (2.9) | 0 | 0 | 9 (31.0) | 2 (6.9) | 5 (14.7) | 3 (8.8) | 15 (12.4) | 6 (5.0) |
| Urinary tract infection | 3 (8.6) | 0 | 3 (13.0) | 0 | 4 (13.8) | 0 | 5 (14.7) | 0 | 15 (12.4) | 0 |
| Pyrexia | 3 (8.6) | 0 | 3 (13.0) | 0 | 4 (13.8) | 0 | 4 (11.8) | 0 | 14 (11.6) | 0 |
| Rash | 4 (11.4) | 0 | 2 (8.7) | 0 | 3 (10.3) | 0 | 5 (14.7) | 0 | 14 (11.6) | 0 |
| Constipation | 1 (2.9) | 0 | 2 (8.7) | 0 | 6 (20.7) | 0 | 4 (11.8) | 0 | 13 (10.7) | 0 |
| Pneumonia | 1 (2.9) | 0 | 5 (21.7) | 3 (13.0) | 0 | 0 | 7 (20.6) | 2 (5.9) | 13 (10.7) | 5 (4.1) |
| Dyspnea | 2 (5.7) | 0 | 3 (13.0) | 1 (4.3) | 1 (3.4) | 0 | 6 (17.6) | 0 | 12 (9.9) | 1 (0.8) |
| Fatigue | 5 (14.3) | 0 | 2 (8.7) | 0 | 2 (6.9) | 0 | 2 (5.9) | 0 | 11 (9.1) | 0 |
| Hypothyroidism | 5 (14.3) | 0 | 1 (4.3) | 0 | 2 (6.9) | 0 | 3 (8.8) | 0 | 11 (9.1) | 0 |
| Nausea | 4 (11.4) | 0 | 0 | 0 | 4 (13.8) | 0 | 3 (8.8) | 0 | 11 (9.1) | 0 |
| Blood creatinine increased | 1 (2.9) | 0 | 1 (4.3) | 0 | 5 (17.2) | 1 (3.4) | 2 (5.9) | 0 | 9 (7.4) | 1 (0.8) |
| Cough | 4 (11.4) | 0 | 0 | 0 | 1 (3.4) | 0 | 4 (11.8) | 0 | 9 (7.4) | 0 |
| Headache | 7 (20.0) | 1 (2.9) | 1 (4.3) | 0 | 1 (3.4) | 0 | 0 | 0 | 9 (7.4) | 1 (0.8) |
| Peripheral edema | 1 (2.9) | 0 | 1 (4.3) | 0 | 4 (13.8) | 0 | 3 (8.8) | 1 (2.9) | 9 (7.4) | 1 (0.8) |
| Back pain | 2 (5.7) | 0 | 1 (4.3) | 1 (4.3) | 3 (10.3) | 0 | 2 (5.9) | 0 | 8 (6.6) | 1 (0.8) |
| Pain in extremity | 2 (5.7) | 0 | 1 (4.3) | 0 | 3 (10.3) | 0 | 2 (5.9) | 0 | 8 (6.6) | 0 |
| Dry skin | 2 (5.7) | 0 | 1 (4.3) | 1 (4.3) | 1 (3.4) | 0 | 3 (8.8) | 0 | 7 (5.8) | 1 (0.8) |
| Paresthesia | 3 (8.6) | 0 | 0 | 0 | 1 (3.4) | 0 | 3 (8.8) | 0 | 7 (5.8) | 0 |
| ALT increased | 1 (2.9) | 1 (2.9) | 2 (8.7) | 2 (8.7) | 1 (3.4) | 0 | 2 (5.9) | 1 (2.9) | 6 (5.0) | 4 (3.3) |
| Hypertension | 0 | 0 | 1 (4.3) | 0 | 3 (10.3) | 2 (6.9) | 2 (5.9) | 2 (5.9) | 6 (5.0) | 4 (3.3) |
| Myalgia | 2 (5.7) | 0 | 1 (4.3) | 0 | 2 (6.9) | 0 | 1 (2.9) | 0 | 6 (5.0) | 0 |
Data cut-off date: 15 April 2021.
ALT, alanine aminotransferase; MedDRA, Medical Dictionary for Regulatory Activities; NSCLC, non-small-cell lung cancer; RCC, renal cell carcinoma; TEAE, treatment-emergent adverse event; UC, urothelial carcinoma.