Table 2.
Treatment-related Adverse Events
| Adverse Event | Prexasertib
(N=28) Maximum Grade |
||
|---|---|---|---|
|
| |||
| 1–2 | 3 | 4 | |
|
| |||
| Haematological | |||
|
| |||
| Anaemia* | 23 (82%) | 3 (11%) | - |
| Neutropenia | 1 (4%) | 4 (14%) | 22 (79%)** |
| WBC decreased | 4 (14%) | 14 (50%) | 9 (32%) |
| Platelet count decreased† | 16 (57%) | 4 (14%) | 3 (11%) |
| Febrile neutropenia | - | 2 (7%) | - |
|
| |||
| Non-Haematologic | |||
|
| |||
| Fatigue | 13 (46%) | 2 (7%) | - |
| Fever | 8 (29%) | - | - |
| Allergic reaction | 1 (4%) | - | - |
| Headache | 1 (4%) | - | - |
| Nausea | 18 (64%) | - | - |
| Vomiting | 7 (25%) | 1 (4%) | - |
| Diarrhea | 9 (32%) | 2 (7%) | - |
| Constipation | 3 (11%) | - | - |
| Abdominal pain | 4 (14%) | - | - |
| Anorexia | 4 (14%) | - | - |
| Oral mucositis | 4 (14%) | - | - |
| Dyspepsia | 1 (4%) | - | - |
Data are number of patients (total %). A patient could be counted under more than one preferred term.
*
9 patients received packed RBC transfusion due to grade 2 anaemia (N=6) and grade 3 anaemia (N=3).
**
First events of grade 3 and 4 neutropenia were observed from cell counts performed on cycle 1 day 8.
†
Two patients received platelet transfusion due to bacteremia and grade 3 thrombocytopenia on cycle 1 and due to prolonged grade 4 thrombocytopenia on cycle 1. Patients who were on growth factor support also had transient (< 7 days) grade 3 or 4 thrombocytopenia.