Table 2. Rucaparib-related (possibly, probably or almost certainly) adverse events (AEs) that occurred in at least 3 of all 78 patients by grade.
Maximum CTCAE grade per patient for all dose levels, no. (%) |
|||
---|---|---|---|
Adverse event | Grade 1 | Grade 2 | Grade 3 |
Nausea | 22 (28) | 4 (5) | 2 (3) |
Fatigue | 20 (26) | 15 (19) | 5 (6) |
Headache | 12 (15) | 5 (6) | 0 (0) |
Diarrhoea | 11 (14) | 1 (1) | 0 (0) |
Infusion site reactiona | 5 (11) | 1 (2) | 0 (0) |
Dizziness | 8 (10) | 1 (1) | 0 (0) |
Vomiting | 7 (9) | 3 (4) | 0 (0) |
Anorexia | 7 (9) | 1 (1) | 0 (0) |
Constipation | 6 (8) | 1 (1) | 0 (0) |
Alopecia | 6 (8) | 0 (0) | 0 (0) |
Pruritus | 4 (5) | 1 (1) | 0 (0) |
Taste alteration (dysgeusia) | 4 (5) | 1 (1) | 0 (0) |
Anaemia | 0 (0) | 4 (5) | 0 (0) |
Neutropenia | 3 (4) | 1 (1) | 0 (0) |
Dry mouth (xerostomia) | 3 (4) | 0 (0) | 0 (0) |
Elevated transaminase (AST) | 3 (4) | 0 (0) | 0 (0) |
Low mood | 3 (4) | 0 (0) | 1 (1) |
Sensory neuropathy | 3 (4) | 0 (0) | 0 (0) |
Abdominal pain | 2 (3) | 2 (3) | 1 (1) |
Arthralgia | 3 (4) | 2 (3) | 0 (0) |
Myalgia | 2 (3) | 1 (1) | 0 (0) |
Lymphopenia | 1 (1) | 2 (3) | 0 (0) |
Abbreviations: AST=aspartate transaminase; CTCAE=Common Terminology Criteria for Adverse Events.
Data are patient number (%). There were no grade 4/5 AEs.
Intravenous (i.v.) cohort only (n=47).