Table 4.
Summary of AEs by treatment group (safety analysis set)
| AE category | Number (%) of patientsa | ||
|---|---|---|---|
| Fed (n = 30)b | Fasted (n = 29)b | Total (N = 31) | |
| Any AE | 25 (83.3) | 23 (79.3) | 30 (96.8) |
| Related to adavosertib treatmentc | 16 (53.3) | 14 (48.3) | 20 (64.5) |
| Any AE of CTCAE grade ≥ 3 | 1 (3.3) | 3 (10.3) | 4 (12.9) |
| Related to adavosertib treatmentc | 1 (3.3) | 1 (3.4) | 2 (6.5) |
| Any SAE | 1 (3.3) | 2 (6.9) | 3 (9.7) |
| Related to adavosertib treatmentc | 0 | 0 | 0 |
AEs were defined according to Medical Dictionary for Regulatory Activities version 20.1
aPatients with multiple events in the same category are counted only once in that category. Patients with events in more than one category are counted once in each of those categories
bThe columns ‘Fed’ and ‘Fasted’ represent all data from the fed and fasted periods irrespective of the treatment sequence the patient was assigned to
cAs assessed by the investigator