Table 3.
Adverse events of any grade occurring in 10% or more of patients (safety population) in olaparib vs placebo arms.
| Subjects - N (%) |
Occurrences - N (%) |
|||
|---|---|---|---|---|
| Olaparib | Placebo | Olaparib | Placebo | |
| N=31 | N=38 | N=31 | N=38 | |
| Blood and lymphatic system | ||||
| Anaemia | 15 (48) | 10 (26) | 45 | 26 |
| Neutropenia | 4 (13) | 0(0) | 6 | 0 |
| Thrombocytopenia | 4 (13) | 1 (3) | 12 | 3 |
| Gastrointestinal disorders | ||||
| Constipation | 4 (13) | 4 (11) | 9 | 7 |
| Diarrhoea | 4 (13) | 8 (21) | 12 | 12 |
| Dry mouth | 1 (3) | 5 (13) | 1 | 5 |
| Dyspepsia | 3 (10) | 7 (18) | 4 | 13 |
| Flatulence | 1 (3) | 5 (13) | 1 | 3 |
| Nausea | 17 (55) | 11 (29) | 44 | 21 |
| Vomiting | 7 (23) | 4 (11) | 17 | 5 |
| General disorders and administration site conditions | ||||
| Fatigue | 20 (65) | 25 (66) | 50 | 66 |
| Oedema peripheral | 3 (10) | 4 (11) | 8 | 6 |
| Infections and infestations | ||||
| Upper respiratory infection | 4 (13) | 5 (13) | 7 | 9 |
| Metabolism and nutrition disorders | ||||
| Anorexia | 11 (35) | 12 (32) | 22 | 21 |
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 5 (16) | 8 (21) | 6 | 10 |
| Nervous System Disorders | ||||
| Dizziness | 6 (19) | 3 (8) | 6 | 3 |
| Headache | 6 (19) | 6 (16) | 8 | 6 |
| Psychiatric disorders | ||||
| Insomnia | 2 (6) | 6 16) | 9 | 8 |
| Respiratory, thoracic, and mediastinal disorders | ||||
| Coughing | 11 (35) | 22 (58) | 33 | 47 |
| Dyspnoea | 13 (42) | 15 (39) | 28 | 35 |
| Skin and subcutaneous tissue disorders | ||||
| Rash | 4 (13) | 3 (8) | 10 | 3 |
| Vascular disorders | ||||
| Hypertension | 3 (10) | 9 (24) | 15 | 18 |