Table 2.
Preferred term, n (%)a | Module 1 (n = 29) |
Module 2 (n = 30) |
Total (N = 59) |
---|---|---|---|
Patients with any possibly relatedb adverse events | 23 (79.3) | 25 (83.3) | 48 (81.4) |
Nausea | 11 (37.9) | 15 (50.0) | 26 (44.1) |
Fatigue | 6 (20.7) | 9 (30.0) | 15 (25.4) |
Decreased appetite | 5 (17.2) | 5 (16.7) | 10 (16.9) |
Vomiting | 3 (10.3) | 7 (23.3) | 10 (16.9) |
Diarrhea | 4 (13.8) | 3 (10.0) | 7 (11.9) |
Dizziness | 4 (13.8) | 2 (6.7) | 6 (10.2) |
Constipation | 3 (10.3) | 1 (3.3) | 4 (6.8) |
Insomnia | 2 (6.9) | 0 | 2 (3.4) |
Hypertension | 0 | 2 (6.7) | 2 (3.4) |
Thrombocytopenia | 0 | 2 (6.7) | 2 (3.4) |
Abdominal pain | 2 (6.9) | 0 | 2 (3.4) |
aPatients with events in more than one preferred term are counted once in each of those preferred terms
bPossibly related, as assessed by the investigator