Table 2. Summary of common treatment-related AEsa and CTC grade ⩾3 AEs.
|
Olaparib dose cohort |
||||||||
|---|---|---|---|---|---|---|---|---|
| 50 mg bid 7 day (n=3) | 100 mg bid 7 day (n=3) | 100 mg bid 28 day (n=4) | 200 mg bid 7 day (n=3) | 200 mg bid 28 day (n=7) | 400 mg bid 7 day (n=12) | 400 mg bid 28 day (n=12) | Total (n=44), n (%) | |
|
Adverse event | ||||||||
| Stomatitis | 3b | 3 | 2 | 2 | 5 | 6 | 11 | 32 (73) |
| |
– |
2c |
– |
– |
1 |
2 |
2 |
7 (16) |
| Nausea | 3 | 2 | 2 | 2 | 3 | 8 | 8 | 28 (64) |
| |
– |
1 |
– |
– |
– |
4 |
– |
5 (11) |
| Asthenia | 2 | 1 | 2 | 2 | 2 | 6 | 6 | 21 (48) |
| |
– |
– |
– |
– |
– |
1 |
– |
1 (2) |
| Anorexia | – | – | 1 | – | 3 | 4 | 4 | 12 (27) |
| |
– |
– |
1 |
– |
1 |
– |
– |
2 (5) |
| Vomiting | – | 1 | – | – | 3 | 6 | 3 | 13 (30) |
| |
– |
– |
– |
– |
– |
1 |
– |
1 (2) |
| Decreased neutrophil count | 2 | 3 | 2 | 1 | 1 | 2 | 2 | 13 (30) |
| |
2 |
3 |
1 |
– |
1 |
1 |
1 |
9 (20) |
| PPES | – | – | – | 1 | 2 | 4 | 4 | 11 (25) |
| – | – | – | – | – | – | 1 | 1 (2) | |
Abbreviations: AEs=adverse events; CTC=Common Terminology Criteria; PPES=palmar–plantar erythrodysesthesia syndrome.
a
AEs experienced by ⩾25% patients overall.
b
Values in bold denote the number of patients (n, (%)) with AEs.
c
Values in non bold denote the number of patients (n, (%)) with grade ⩾3 AEs.