Table 2.
Summary of treatment-related AEs across the full analysis set, part A safety lead-in cohorts, and the part B expansion cohort
| Parameter | Part A safety lead-in cohort 200 mg, n (%) (n = 7) |
Part A safety lead-in cohort 175 mg, n (%) (n = 5) |
Part B expansion cohort, n (%) (n = 80) |
Full analysis set, n (%) (N = 92)a |
|
|---|---|---|---|---|---|
| AE | AE | AE | AE | Grade ≥ 3 AE | |
| Patients with any treatment-related AE | 7 (100) | 4 (80.0) | 67 (83.8) | 78 (84.8) | 31 (33.7) |
| Most common treatment-related AEs | |||||
| Diarrheab | 6 (85.7) | 2 (40.0) | 45 (56.3) | 53 (57.6) | 7 (7.6)c |
| Nauseab | 7 (100.0) | 2 (40.0) | 34 (42.5) | 43 (46.7) | 4 (4.3)c |
| Fatigueb | 5 (71.4) | 2 (40.0) | 29 (36.3) | 36 (39.1) | 2 (2.2)c |
| Vomitingb | 6 (85.7) | 3 (60.0) | 15 (18.8) | 24 (26.1) | 5 (5.4)c |
| Decreased appetiteb | 2 (28.6) | 1 (20.0) | 10 (12.5) | 13 (14.1) | 0 (0)c |
| Treatment-related hematological AEs | |||||
| Anemia | 1 (14.3) | 0 (0) | 8 (10.0) | 9 (9.8) | 4 (4.3) |
| Neutropenia | 1 (14.3) | 0 (0) | 5 (6.3) | 6 (6.5) | 4 (4.3) |
| Thrombocytopenia | 1 (14.3) | 0 (0) | 5 (6.3) | 6 (6.5) | 4 (4.3) |
AE adverse event, N full analysis set, n number of patients
aThe full analysis set included all patients (in the part A safety lead-in and the part B expansion cohort) treated with at least one dose of adavosertib
bAEs listed are those that occurred in ≥ 10% of all patients in part B
cGrade ≥ 3 AEs listed are those that occurred in ≥ 5% of all patients in the full analysis set