Table 3. Summary of number (%) of patients with adverse events of grade 3 or higher, occurring in at least 5% of patients.
|
Initial dose level (olaparib mg bd per DTIC mg m−2)
|
||||||||
|---|---|---|---|---|---|---|---|---|
| Number of patients with AE (%) | 10/600 (n=3) | 20/600 (n=4) | 20/800 (n=4) | 40/600 (n=4) | 40/800 (n=6) | 100/600 (n=13) | 200/600 (n=6) | Total overall (n=40) |
| Patients with any grade 3 or higher adverse events | 2 (66.7) | 4 (100) | 1 (25.0) | 2 (50.0) | 5 (83.3) | 9 (69.2) | 6 (100) | 29 (72.5) |
| Blood and lymphatic system | ||||||||
| Anaemia | 0 | 1 (25.0) | 0 | 0 | 0 | 0 | 1 (16.7) | 2 (5.0) |
| Leucopoenia | 0 | 1 (25.0) | 0 | 0 | 1 (16.7) | 1 (7.7) | 2 (33.3) | 5 (12.5) |
| Lymphopaenia | 0 | 1 (25.0) | 0 | 0 | 1 (16.7) | 2 (15.4) | 2 (33.3) | 6 (15.0) |
| Neutropaenia | 0 | 1 (25.0) | 0 | 0 | 3 (50.0) | 3 (23.1) | 2 (33.3) | 9 (22.5) |
| Thrombocytopaenia | 0 | 0 | 0 | 0 | 1 (16.7) | 0 | 2 (33.3) | 3 (7.5) |
| Gastrointestinal | ||||||||
| Abdominal pain upper | 0 | 0 | 0 | 0 | 1 (16.7) | 1 (7.7) | 0 | 2 (5.0) |
| Metabolism and nutrition | ||||||||
| Hyperglycaemia | 0 | 0 | 0 | 1 (25.0) | 0 | 1 (7.7) | 0 | 2 (5.0) |
| Hyponatraemia | 1 (33.3) | 1 (25.0) | 0 | 0 | 0 | 0 | 0 | 2 (5.0) |
| Hypophosphataemia | 1 (33.3) | 1 (25.0) | 0 | 0 | 1 (16.7) | 1 (7.7) | 0 | 4 (10.0) |
| Musculoskeletal and connective tissue | ||||||||
| Arthralgia | 0 | 0 | 0 | 1 (25.0) | 1 (16.7) | 0 | 0 | 2 (5.0) |
| Back pain | 0 | 0 | 0 | 0 | 1 (16.7) | 1 (7.7) | 0 | 2 (5.0) |
| Nervous system | ||||||||
| Lethargy | 0 | 0 | 1 (25.0) | 0 | 0 | 1 (7.7) | 0 | 2 (5.0) |
Abbreviations: AE=adverse events; CTCAE=Comman Terminology Criteria for Adverse Events, CTCAE grade 3=severe; 4=life threatening or disabling; DTIC=dimethyltriazenoimidazole carboxamide.