Patients, n (%) | Xe1000+Ev10+Ex25 (n = 70) | Ev10+Ex25 (n = 69) | ||
---|---|---|---|---|
Any AE | 70 (100.0) | 68 (98.6) | ||
Any grade ≥ 3 AE | 39 (55.7) | 31 (44.9) | ||
Any TRAE | 66 (94.3) | 66 (95.7) | ||
Any grade ≥ 3 TRAE | 31 (44.3) | 21 (30.4) | ||
Any serious AE | 15 (21.4) | 20 (29.0) | ||
Most common any-cause AEs | Any grade | Grade ≥ 3 | Any grade | Grade ≥ 3 |
Diarrhoea | 29 (41.4) | 1 (1.4) | 20 (29.0) | 1 (1.4) |
Mucosal inflammation | 27 (38.6) | 2 (2.9) | 21 (30.4) | 0 |
Stomatitis | 24 (34.3) | 4 (5.7) | 24 (34.8) | 3 (4.3) |
Nausea | 24 (34.3) | 0 | 16 (23.2) | 0 |
Rash | 23 (32.9) | 0 | 21 (30.4) | 0 |
Cough | 23 (32.9) | 1 (1.4) | 16 (23.2) | 2 (2.9) |
Asthenia | 21 (30.0) | 1 (1.4) | 24 (34.8) | 2 (2.9) |
Fatigue | 20 (28.6) | 0 | 17 (24.6) | 1 (1.4) |
Neutropenia | 20 (28.6) | 8 (11.4) | 11 (15.9) | 2 (2.9) |
Decreased appetite | 18 (25.7) | 1 (1.4) | 21 (30.4) | 0 |
Hyperglycaemia | 18 (25.7) | 4 (5.7) | 15 (21.7) | 3 (4.3) |
Headache | 17 (24.3) | 0 | 9 (13.0) | 0 |
Thrombocytopenia | 17 (24.3) | 4 (5.7) | 10 (14.5) | 1 (1.4) |
ALT increased | 16 (22.9) | 3 (4.3) | 10 (14.5) | 1 (1.4) |
Anaemia | 15 (21.4) | 2 (2.9) | 11 (15.9) | 2 (2.9) |
Vomiting | 14 (20.0) | 2 (2.9) | 13 (18.8) | 0 |
AST increased | 13 (18.6) | 3 (4.3) | 13 (18.8) | 0 |
Epistaxis | 13 (18.6) | 0 | 9 (13.0) | 1 (1.4) |
Platelet count decreased | 13 (18.6) | 1 (1.4) | 3 (4.3) | 0 |
Constipation | 13 (18.6) | 1 (1.4) | 6 (8.7) | 0 |
Pruritus | 13 (18.6) | 0 | 12 (17.4) | 0 |
Nasopharyngitis | 12 (17.1) | 0 | 6 (8.7) | 0 |
Hypophosphataemia | 11 (15.7) | 6 (8.6) | 8 (11.6) | 2 (2.9) |
Dysgeusia | 11 (15.7) | 0 | 10 (14.5) | 0 |
Dyspnoea | 9 (12.9) | 1 (1.4) | 17 (24.6) | 4 (5.8) |
Peripheral oedema | 5 (7.1) | 0 | 14 (20.3) | 0 |
Arthralgia | 4 (5.7) | 0 | 11 (15.9) | 0 |
Mouth ulceration | 3 (4.3) | 0 | 12 (17.4) | 0 |