| Olaparib 300 mg twice daily (bd) | Placebo |
---|
Total, other (not including serious) adverse events
| | |
---|
# participants affected / at risk
| 89/90 (98.89%) | 56/61 (91.80%) |
Gastrointestinal disorders | | |
---|
Nausea1 | | |
# participants affected / at risk | 44/90 (48.89%) | 15/61 (24.59%) |
# events | 66 | 17 |
Gastrointestinal disorders | | |
---|
Diarrhoea1 | | |
# participants affected / at risk | 34/90 (37.78%) | 10/61 (16.39%) |
# events | 49 | 11 |
Gastrointestinal disorders | | |
---|
Abdominal pain1 | | |
# participants affected / at risk | 26/90 (28.89%) | 15/61 (24.59%) |
# events | 39 | 17 |
Gastrointestinal disorders | | |
---|
Constipation1 | | |
# participants affected / at risk | 25/90 (27.78%) | 7/61 (11.48%) |
# events | 33 | 8 |
Gastrointestinal disorders | | |
---|
Vomiting1 | | |
# participants affected / at risk | 23/90 (25.56%) | 9/61 (14.75%) |
# events | 49 | 12 |
Gastrointestinal disorders | | |
---|
Stomatitis1 | | |
# participants affected / at risk | 8/90 (8.89%) | 3/61 (4.92%) |
# events | 10 | 3 |
Gastrointestinal disorders | | |
---|
Abdominal pain upper1 | | |
# participants affected / at risk | 9/90 (10.00%) | 9/61 (14.75%) |
# events | 11 | 10 |
Gastrointestinal disorders | | |
---|
Dry mouth1 | | |
# participants affected / at risk | 8/90 (8.89%) | 1/61 (1.64%) |
# events | 8 | 2 |
Gastrointestinal disorders | | |
---|
Dyspepsia1 | | |
# participants affected / at risk | 9/90 (10.00%) | 5/61 (8.20%) |
# events | 16 | 5 |
Gastrointestinal disorders | | |
---|
Abdominal distension1 | | |
# participants affected / at risk | 5/90 (5.56%) | 6/61 (9.84%) |
# events | 6 | 6 |
Gastrointestinal disorders | | |
---|
Flatulence1 | | |
# participants affected / at risk | 2/90 (2.22%) | 4/61 (6.56%) |
# events | 3 | 4 |
General disorders | | |
---|
Fatigue1 | | |
# participants affected / at risk | 42/90 (46.67%) | 16/61 (26.23%) |
# events | 47 | 19 |
General disorders | | |
---|
Asthenia1 | | |
# participants affected / at risk | 16/90 (17.78%) | 6/61 (9.84%) |
# events | 24 | 6 |
General disorders | | |
---|
Pyrexia1 | | |
# participants affected / at risk | 17/90 (18.89%) | 4/61 (6.56%) |
# events | 28 | 5 |
General disorders | | |
---|
Oedema peripheral1 | | |
# participants affected / at risk | 8/90 (8.89%) | 5/61 (8.20%) |
# events | 11 | 5 |
Musculoskeletal and connective tissue disorders | | |
---|
Back pain1 | | |
# participants affected / at risk | 24/90 (26.67%) | 13/61 (21.31%) |
# events | 28 | 13 |
Musculoskeletal and connective tissue disorders | | |
---|
Arthralgia1 | | |
# participants affected / at risk | 19/90 (21.11%) | 11/61 (18.03%) |
# events | 25 | 11 |
Musculoskeletal and connective tissue disorders | | |
---|
Muscle spasms1 | | |
# participants affected / at risk | 6/90 (6.67%) | 2/61 (3.28%) |
# events | 9 | 2 |
Musculoskeletal and connective tissue disorders | | |
---|
Pain in extremity1 | | |
# participants affected / at risk | 8/90 (8.89%) | 4/61 (6.56%) |
# events | 10 | 4 |
Musculoskeletal and connective tissue disorders | | |
---|
Myalgia1 | | |
# participants affected / at risk | 6/90 (6.67%) | 3/61 (4.92%) |
# events | 6 | 5 |
Musculoskeletal and connective tissue disorders | | |
---|
Flank pain1 | | |
# participants affected / at risk | 3/90 (3.33%) | 4/61 (6.56%) |
# events | 3 | 4 |
Nervous system disorders | | |
---|
Dysgeusia1 | | |
# participants affected / at risk | 6/90 (6.67%) | 3/61 (4.92%) |
# events | 6 | 3 |
Nervous system disorders | | |
---|
Neuropathy peripheral1 | | |
# participants affected / at risk | 9/90 (10.00%) | 7/61 (11.48%) |
# events | 10 | 7 |
Nervous system disorders | | |
---|
Dizziness1 | | |
# participants affected / at risk | 8/90 (8.89%) | 3/61 (4.92%) |
# events | 8 | 4 |
Nervous system disorders | | |
---|
Headache1 | | |
# participants affected / at risk | 8/90 (8.89%) | 8/61 (13.11%) |
# events | 10 | 8 |
Nervous system disorders | | |
---|
Peripheral sensory neuropathy1 | | |
# participants affected / at risk | 6/90 (6.67%) | 2/61 (3.28%) |
# events | 6 | 2 |
Blood and lymphatic system disorders | | |
---|
Anaemia1 | | |
# participants affected / at risk | 26/90 (28.89%) | 10/61 (16.39%) |
# events | 35 | 12 |
Blood and lymphatic system disorders | | |
---|
Neutropenia1 | | |
# participants affected / at risk | 8/90 (8.89%) | 4/61 (6.56%) |
# events | 9 | 4 |
Blood and lymphatic system disorders | | |
---|
Thrombocytopenia1 | | |
# participants affected / at risk | 8/90 (8.89%) | 4/61 (6.56%) |
# events | 9 | 4 |
Metabolism and nutrition disorders | | |
---|
Decreased appetite1 | | |
# participants affected / at risk | 24/90 (26.67%) | 4/61 (6.56%) |
# events | 29 | 5 |
Metabolism and nutrition disorders | | |
---|
Hyperglycaemia1 | | |
# participants affected / at risk | 8/90 (8.89%) | 1/61 (1.64%) |
# events | 15 | 1 |
Skin and subcutaneous tissue disorders | | |
---|
Rash1 | | |
# participants affected / at risk | 12/90 (13.33%) | 3/61 (4.92%) |
# events | 15 | 4 |
Skin and subcutaneous tissue disorders | | |
---|
Pruritus1 | | |
# participants affected / at risk | 9/90 (10.00%) | 4/61 (6.56%) |
# events | 11 | 4 |
Investigations | | |
---|
Alanine aminotransferase increased1 | | |
# participants affected / at risk | 10/90 (11.11%) | 1/61 (1.64%) |
# events | 16 | 1 |
Investigations | | |
---|
Aspartate aminotransferase increased1 | | |
# participants affected / at risk | 8/90 (8.89%) | 1/61 (1.64%) |
# events | 14 | 1 |
Investigations | | |
---|
Blood creatinine increased1 | | |
# participants affected / at risk | 7/90 (7.78%) | 2/61 (3.28%) |
# events | 12 | 2 |
Investigations | | |
---|
Blood alkaline phosphatase increased1 | | |
# participants affected / at risk | 6/90 (6.67%) | 3/61 (4.92%) |
# events | 7 | 3 |
Investigations | | |
---|
Platelet count decreased1 | | |
# participants affected / at risk | 5/90 (5.56%) | 0/61 (0.00%) |
# events | 9 | 0 |
Psychiatric disorders | | |
---|
Insomnia1 | | |
# participants affected / at risk | 8/90 (8.89%) | 1/61 (1.64%) |
# events | 8 | 1 |
Psychiatric disorders | | |
---|
Anxiety1 | | |
# participants affected / at risk | 9/90 (10.00%) | 2/61 (3.28%) |
# events | 10 | 2 |
Psychiatric disorders | | |
---|
Depression1 | | |
# participants affected / at risk | 5/90 (5.56%) | 0/61 (0.00%) |
# events | 6 | 0 |
Respiratory, thoracic and mediastinal disorders | | |
---|
Dyspnoea1 | | |
# participants affected / at risk | 10/90 (11.11%) | 3/61 (4.92%) |
# events | 11 | 4 |
Respiratory, thoracic and mediastinal disorders | | |
---|
Cough1 | | |
# participants affected / at risk | 9/90 (10.00%) | 2/61 (3.28%) |
# events | 13 | 3 |
Infections and infestations | | |
---|
Nasopharyngitis1 | | |
# participants affected / at risk | 12/90 (13.33%) | 2/61 (3.28%) |
# events | 21 | 2 |
Infections and infestations | | |
---|
Influenza1 | | |
# participants affected / at risk | 6/90 (6.67%) | 0/61 (0.00%) |
# events | 8 | 0 |
Gastrointestinal disorders | | |
---|
Gastrooesophageal reflux disease1 | | |
# participants affected / at risk | 5/90 (5.56%) | 2/61 (3.28%) |
# events | 5 | 2 |
General disorders | | |
---|
Influenza like illness1 | | |
# participants affected / at risk | 6/90 (6.67%) | 0/61 (0.00%) |
# events | 6 | 0 |
Nervous system disorders | | |
---|
Paraesthesia1 | | |
# participants affected / at risk | 2/90 (2.22%) | 4/61 (6.56%) |
# events | 3 | 4 |
Blood and lymphatic system disorders | | |
---|
Lymphopenia1 | | |
# participants affected / at risk | 5/90 (5.56%) | 0/61 (0.00%) |
# events | 9 | 0 |
Investigations | | |
---|
Weight decreased1 | | |
# participants affected / at risk | 7/90 (7.78%) | 3/61 (4.92%) |
# events | 7 | 3 |
Investigations | | |
---|
Gamma-glutamyltransferase increased1 | | |
# participants affected / at risk | 6/90 (6.67%) | 1/61 (1.64%) |
# events | 9 | 1 |
Investigations | | |
---|
Neutrophil count decreased1 | | |
# participants affected / at risk | 6/90 (6.67%) | 0/61 (0.00%) |
# events | 16 | 0 |
Vascular disorders | | |
---|
Hypertension1 | | |
# participants affected / at risk | 5/90 (5.56%) | 3/61 (4.92%) |
# events | 12 | 3 |
|