Table 4. Frequency of SAEs and grade 3 or 4 AEs.
| |
Randomised |
Non-randomised |
|
|---|---|---|---|
| n (%) | Standard dose (n=77) | Dose escalation (n=71) | Grade ⩾2 rash (n=105) |
|
SAEs (all grades) | |||
| Gastrointestinal disorders | 5 (6.5) | 5 (7.0) | 11 (10.5) |
| Infections and infestations | 6 (7.8) | 6 (8.5) | 12 (11.4) |
| General disorders and administration site conditions | 5 (6.5) | 7 (9.9) | 6 (5.7) |
| Blood and lymphatic disorders | 2 (2.6) | 3 (4.2) | 6 (5.7) |
| Hepatobiliary disorders | 2 (2.6) | 5 (7.0) | 2 (1.9) |
| Respiratory, thoracic and, mediastinal disorders | 1 (1.3) | 1 (1.4) | 6 (5.7) |
| Nervous system disorders | 3 (3.9) | — | 1 (1.0) |
| Vascular disorders | 5 (6.5) | 1 (1.4) | 3 (2.9) |
| Metabolism and nutrition disorders | — | 2 (2.8) | 3 (2.9) |
| Cardiac disorders | 2 (2.6) | 1 (1.4) | 3 (2.9) |
| Renal and urinary disorders | — | 1 (1.4) | 1 (1.0) |
| Injury, poisoning, and procedural complications | — | 1 (1.4) | — |
| Surgical and medical procedures |
— |
1 (1.4) |
— |
|
Grade 3 or 4 AEs | |||
| Rash | 0 (0) | 3 (4.2) | 19 (18.1) |
| Diarrhoea | 1 (1.3) | 2 (2.8) | 4 (3.8) |
| Thrombocytopenia | 0 (0) | 5 (7.0) | 7 (6.7) |
| Anaemia | 4 (5.2) | 7 (9.9) | 9 (8.6) |
| Neutropenia | 12 (15.6) | 11 (15.5) | 29 (27.6) |
| Fatigue | 2 (2.6) | 6 (8.5) | 6 (5.7) |
| Dyspnoea | 2 (2.6) | 0 (0) | 4 (3.8) |
| Pulmonary embolism | 0 (0) | 1 (1.4) | 3 (2.9) |
| Deep vein thrombosis | 1 (1.3) | 0 (0) | 4 (3.7) |
| Cardiac failure | 1 (1.3) | 0 (0) | 0 (0) |
| Hypertension | 0 (0) | 3 (4.2) | 1 (1.0) |
| Lung infiltration | 0 (0) | 0 (0) | 1 (1.0) |
Abbreviations: AE=adverse event; SAE=serious adverse event.