Table 4. Number of patients with AEs grade 3 or 4 in >5% of patients in schedules A and B combined irrespective of relatedness: schedule B (all doses).
| |
50 (n=4) |
100 (n=4) |
150 (n=16) |
200 (n=3) |
Total (n=27) |
|||||
|---|---|---|---|---|---|---|---|---|---|---|
| Schedule B (mg) n (%) | Grade 3 | Grade 4 | Grade 3 | Grade 4 | Grade 3 | Grade 4 | Grade 3 | Grade 4 | Grade 3 | Grade 4 |
| Anaemia |
1 |
— |
— |
— |
1 |
2 |
2 |
— |
4 (14.8) |
2 (7.4) |
| Neutropenia |
— |
— |
— |
— |
2 |
1 |
— |
2 |
2 (7.4) |
3 (11.1) |
| Leukopenia |
— |
— |
— |
— |
1 |
— |
— |
1 |
1 (3.7) |
1 (3.7) |
| Abdominal pain |
— |
— |
— |
— |
2 |
— |
— |
— |
2 (7.4) |
— |
| Thrombocytopenia |
— |
— |
— |
— |
— |
— |
2 |
— |
2 (7.4) |
— |
| Fatigue |
— |
— |
— |
— |
1 |
— |
1 |
— |
2 (7.4) |
— |
| Pain |
— |
— |
— |
— |
2 |
— |
— |
— |
2 (7.4) |
— |
| Hypokalaemia |
— |
— |
1 |
— |
— |
— |
1 |
— |
2 (7.4) |
— |
| Upper GI haemorrhage |
— |
— |
— |
— |
1 |
— |
1 |
— |
2 (7.4) |
— |
| Infection |
1 |
— |
— |
— |
— |
— |
1 |
— |
2 (7.4) |
— |
| Ileus |
— |
— |
— |
— |
— |
— |
2 |
— |
2 (7.4) |
— |
| Dyspnoea |
— |
— |
1 |
— |
— |
— |
— |
— |
1 (3.7) |
— |
| Vomiting |
— |
— |
— |
— |
1 |
— |
— |
— |
1 (3.7) |
— |
| Decreased appetite |
— |
— |
— |
— |
— |
— |
1 |
— |
1 (3.7) |
— |
| Rash |
— |
— |
— |
— |
1 |
— |
— |
— |
1 (3.7) |
— |
| Abdominal distension |
— |
— |
— |
— |
— |
— |
1 |
— |
1 (3.7) |
— |
| Dizziness |
— |
— |
— |
— |
1 |
— |
— |
— |
1 (3.7) |
— |
| Febrile neutropenia | — | — | — | — | — | — | 1 | — | 1 (3.7) | — |
Abbreviations: AEs=adverse events; GI=gastrointestinal.