Table 4. Most common grade 3 and 4 toxicities (safety population).
|
No. of patients (%)
|
||||
|---|---|---|---|---|
|
ASA404-CP (n=37)
|
CP (n=36)
|
|||
| Toxicity | Grade 3 | Grade 4 | Grade 3 | Grade 4 |
| Neutropenia | 8 (21.6) | 15 (40.5) | 10 (27.8) | 4 (11.1) |
| Leukopenia | 5 (13.5) | 5 (13.5) | 9 (25.0) | 1 (2.8) |
| Alopecia | 7 (18.9) | 1 (2.7) | 10 (27.8) | 0 |
| Hyperglycaemia | 5 (13.5) | 0 | 9 (25.0) | 0 |
| Neuropathy | 2 (5.4) | 0 | 7 (19.4) | 0 |
| Anaemia | 3 (8.1) | 0 | 5 (13.9) | 0 |
| Thrombocytopenia | 2 (5.4) | 2 (5.4) | 2 (5.6) | 0 |
| Gastrointestinal disorders | 3 (8.1) | 0 | 2 (5.6) | 1 (2.8) |
| Infection | 4 (10.8) | 0 | 1 (2.8) | 0 |
| Arthralgia, back or extremity pain | 2 (5.4) | 0 | 3 (8.3) | 0 |
| Cardiac disorders | 3 (8.1) | 1 (2.7) | 1 (2.8) | 0 |
| Hypokalaemia | 3 (8.1) | 0 | 0 | 0 |
| Respiratory, thoracic and mediastinal | 3 (8.1) | 0 | 0 | 0 |
| Infusion site burning/pain | 2 (5.4) | 0 | 0 | 0 |
| Dehydration | 1 (2.7) | 0 | 1 (2.8) | 0 |
| Anaphylactic shock or hypersensitivity | 0 | 0 | 2 (5.6) | 0 |
| Neoplasms benign, malignant and unspecified | 0 | 0 | 2 (5.6) | 0 |
| Flushing or hypotension | 0 | 0 | 2 (5.6) | 0 |
| Febrile neutropenia | 0 | 1 (2.7) | 1 (2.8) | 0 |
ASA404-CP=ASA404 combined with carboplatin and paclitaxel; CP=carboplatin and paclitaxel.