Table 3 Summary of treatment-related AEs.
AEa | ITT (n = 141) | A (n = 4) | B (n = 20) | C (n = 46) | D (n = 10) | E (n = 46) | F (n = 6) | G (n = 9) | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Any | Grade ≥ 3 | Any | Grade ≥ 3 | Any | Grade ≥ 3 | Any | Grade ≥ 3 | Any | Grade ≥ 3 | Any | Grade ≥ 3 | Any | Grade ≥ 3 | Any | Grade ≥ 3 | |
n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | |
Nausea | 33 (23.4) | 0 | 1 (25.0) | 0 | 2 (10.0) | 0 | 6 (13.0) | 0 | 5 (50.0) | 0 | 18 (39.1) | 0 | 1 (16.7) | 0 | 0 | 0 |
Anorexia | 21 (14.9) | 3 (2.1) | 2 (50.0) | 0 | 0 | 0 | 2 (4.3) | 1 (2.2) | 1 (10.0) | 0 | 12 (26.1) | 2 (4.3) | 4 (66.7) | 0 | 0 | 0 |
Vomiting | 20 (14.2) | 0 | 1 (25.0) | 0 | 2 (10.0) | 0 | 4 (8.7) | 0 | 3 (30.0) | 0 | 10 (21.7) | 0 | 0 | 0 | 0 | 0 |
Diarrhea | 14 (9.9) | 1 (0.7) | 3 (75.0) | 0 | 2 (10.0) | 1 (5.0) | 3 (6.5) | 0 | 0 | 0 | 6 (13.0) | 0 | 0 | 0 | 0 | 0 |
Constipation | 3 (2.1) | 0 | 0 | 0 | 0 | 0 | 1 (2.2) | 0 | 1 (10.0) | 0 | 1 (2.2) | 0 | 0 | 0 | 0 | 0 |
Dyspnea | 6 (4.3) | 1 (0.7) | 0 | 0 | 1 (5.0) | 1 (5.0) | 1 (2.2) | 0 | 0 | 0 | 3 (6.5) | 1 (2.2) | 1 (16.7) | 0 | 0 | 0 |
Cough | 9 (6.4) | 0 | 0 | 0 | 0 | 0 | 2 (4.3) | 0 | 0 | 0 | 5 (10.9) | 0 | 2 (33.3) | 0 | 0 | 0 |
Fatigue | 40 (28.4) | 0 | 1 (25.0) | 0 | 3 (15.0) | 0 | 12 (26.1) | 0 | 1 (10.0) | 0 | 19 (41.3) | 0 | 2 (33.3) | 0 | 2 (22.2) | 0 |
Pyrexia | 8 (5.7) | 2 (1.4) | 0 | 0 | 0 | 0 | 5 (10.9) | 1 (2.2) | 0 | 0 | 1 (2.2) | 0 | 1 (16.7) | 0 | 1 (11.1) | 1 (11.1) |
Weight loss | 13 (9.2) | 0 | 2 (50.0) | 0 | 0 | 0 | 2 (4.3) | 0 | 0 | 0 | 8 (17.4) | 0 | 0 | 0 | 1 (11.1) | 0 |
Rash | 10 (7.1) | 1 (0.7) | 0 | 0 | 0 | 0 | 6 (13.0) | 1 (2.2)b | 0 | 0 | 4 (8.7) | 0 | 0 | 0 | 0 | 0 |
Arthralgia | 6 (4.3) | 0 | 0 | 0 | 1 (5.0) | 0 | 2 (4.3) | 0 | 1 (10.0) | 0 | 2 (4.3) | 0 | 0 | 0 | 0 | 0 |
Myalgia | 4 (2.8) | 0 | 0 | 0 | 0 | 0 | 3 (6.5) | 0 | 1 (10.0) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Back pain | 3 (2.1) | 1 (0.7) | 0 | 0 | 1 (5.0) | 0 | 0 | 0 | 0 | 0 | 1 (2.2) | 0 | 1 (16.7) | 1 (16.7) | 0 | 0 |
Mucositis | 20 (14.2) | 0 | 2 (50.0) | 0 | 2 (10.0) | 0 | 3 (6.5) | 0 | 1 (10.0) | 0 | 6 (13.0) | 0 | 3 (50.0) | 0 | 3 (33.3) | 0 |
PPE | 20 (14.2) | 3 (2.1) | 1 (25.0) | 0 | 0 | 0 | 2 (4.3) | 0 | 0 | 0 | 17 (37.0) | 4 (8.7) | 1 (16.7) | 0 | 0 | 0 |
Peripheral neuropathy | 34 (24.1) | 0 | 1 (25.0) | 0 | 3 (15.0) | 0 | 20 (43.5) | 0 | 0 | 0 | 9 (19.6) | 0 | 0 | 0 | 1 (11.1) | 0 |
Pneumonia | 8 (5.7) | 2 (1.4) | 0 | 0 | 1 (5.0) | 0 | 2 (4.3) | 0 | 0 | 0 | 1 (2.2) | 0 | 0 | 0 | 4 (44.4) | 2 (22.2) |
Hypertension | 29 (20.6) | 7 (5.0) | 0 | 0 | 0 | 0 | 2 (4.3) | 0 | 1 (10.0) | 0 | 22 (47.8) | 6 (13.0) | 3 (50.0) | 1 (16.7) | 1 (11.1) | 0 |
Anemia | 78 (55.3) | 17 (12.1) | 1 (25.0) | 0 | 8 (40.0) | 4 (20.0) | 29 (63.0) | 5 (10.9) | 5 (50.0) | 1 (10.0) | 25 (54.3) | 3 (6.5) | 4 (66.7) | 1 (16.7) | 5 (55.6) | 3 (33.3) |
Leukopenia | 82 (58.2) | 22 (15.6) | 1 (25.0) | 0 | 6 (30.0) | 0 | 34 (74.0) | 12 (26.1) | 4 (40.0) | 1 (10.0) | 25 (54.3) | 6 (13.0) | 4 (66.7) | 1 (16.7) | 8 (88.9) | 2 (22.2) |
Neutropenia | 51 (36.2) | 21 (14.9) | 1 (25.0) | 0 | 3 (15.0) | 1 (5.0) | 23 (50.0) | 11 (23.9) | 3 (30.0) | 2 (20.0) | 15 (32.6) | 4 (8.7) | 4 (66.7) | 2 (33.3) | 2 (22.2) | 1 (11.1) |
Thrombocytopenia | 48 (34.0) | 14 (9.9) | 1 (25.0) | 0 | 6 (30.0) | 3 (15.0) | 12 (26.1) | 3 (6.5) | 5 (50.0) | 4 (40.0) | 16 (34.8) | 2 (4.3) | 3 (50.0) | 1 (16.7) | 5 (55.6) | 1 (11.1) |
Elevated ALT/AST | 35 (24.8) | 3 (2.1) | 1 (25.0) | 0 | 5 (25.0) | 0 | 10 (21.7) | 2 (4.3) | 0 | 0 | 13 (28.3) | 2 (4.3) | 3 (50.0) | 0 | 3 (33.3) | 0 |
Proteinuria | 21 (14.9) | 4 (2.8) | 0 | 0 | 0 | 0 | 1 (2.2) | 0 | 0 | 0 | 16 (34.8) | 4 (8.7) | 5 (83.3) | 1 (16.7) | 0 | 0 |
Urinary occult blood | 2 (1.4) | 1 (0.7) | 0 | 0 | 0 | 0 | 0 | 0 | 1 (10.0) | 1 (10.0) | 0 | 0 | 1 (16.7) | 0 | 0 | 0 |
RCCEP | 28 (19.9) | 1 (0.7) | 0 | 0 | 0 | 0 | 28 (60.9) | 1 (2.2) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Hypothyroidism | 6 (4.3) | 1 (0.7) | 0 | 0 | 0 | 0 | 4 (8.7) | 1 (2.2) | 0 | 0 | 2 (4.3) | 0 | 0 | 0 | 0 | 0 |
Hyperglycemia | 3 (2.1) | 1 (0.7) | 0 | 0 | 0 | 0 | 2 (4.3) | 1 (2.2) | 0 | 0 | 1 (2.2) | 0 | 0 | 0 | 0 | 0 |
Hypokalemia | 1 (0.7) | 1 (0.7) | 1 (25.0) | 1 (25.0) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Stroke | 1 (0.7) | 1 (0.7) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (2.2) | 1 (2.2) | 0 | 0 | 0 | 0 |
Edema limbs | 9 (6.4) | 0 | 0 | 0 | 0 | 0 | 7 (15.2) | 0 | 0 | 0 | 2 (4.3) | 0 | 0 | 0 | 0 | 0 |
Skin ulceration | 3 (2.1) | 3 (2.1) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 (6.5) | 3 (6.5) | 0 | 0 | 0 | 0 |