Table 2.
Adverse events (any cause; all grades) occurring in ≥15% of patients, by MedDRA preferred term
| Barasertib dose + LDAC 400 mg | ||||
|---|---|---|---|---|
| Adverse event (AE), n (%) | 800 mg (n=6) |
1000 mg (n=13) |
1200 mg (n=3) |
Total (n=22) |
| Any AE | 6 | 13 | 3 | 22 (100) |
| Febrile neutropenia | 4 | 9 | 0 | 13 (59) |
| Nausea | 4 | 6 | 1 | 11 (50) |
| Diarrhea | 5 | 5 | 0 | 10 (46) |
| Peripheral edema | 2 | 7 | 0 | 9 (41) |
| Stomatitis | 3 | 4 | 2 | 9 (41) |
| Alopecia | 2 | 4 | 0 | 6 (27) |
| Constipation | 3 | 3 | 0 | 6 (27) |
| Petechiae | 3 | 2 | 1 | 6 (27) |
| Pneumonia | 3 | 3 | 0 | 6 (27) |
| Vomiting | 3 | 2 | 1 | 6 (27) |
| Confusional state | 2 | 3 | 0 | 5 (23) |
| Headache | 3 | 2 | 0 | 5 (23) |
| Oropharyngeal pain | 1 | 4 | 0 | 5 (23) |
| Pyrexia | 3 | 2 | 0 | 5 (23) |
| Cough | 1 | 3 | 0 | 4 (18) |
| Decreased appetite | 2 | 1 | 1 | 4 (18) |
| Hemorrhoids | 1 | 3 | 0 | 4 (18) |
| Hypertension | 0 | 3 | 1 | 4 (18) |
| Insomnia | 0 | 3 | 1 | 4 (18) |
| Musculoskeletal pain | 2 | 2 | 0 | 4 (18) |
| Neutropenia | 1 | 2 | 1 | 4 (18) |
| Rash | 2 | 2 | 0 | 4 (18) |