Table 3 Summary of adverse events—safety analysis set
AE Summary, n (%) | (N = 367) |
|---|---|
Any AE | 132 (36.0) |
AE intensity | |
Mild | 67 (18.3) |
Moderate | 72 (19.6) |
Severe | 22 (6.0) |
Unknown | 7 (1.9) |
Treatment-related AEs | 55 (15.0) |
Treatment-related AE intensity | |
Mild | 23 (6.3) |
Moderate | 28 (7.6) |
Severe | 7 (1.9) |
Unknown | 3 (0.8) |
Serious AEs | 23 (6.3) |
Treatment-related serious AEs | 0 |
AEs leading to discontinuation | 36 (9.8) |
Frequency of AEs by preferred term (occurring in >1 % of patients) | |
Diarrhea | 20 (5.4) |
Headache | 15 (4.1) |
Urinary tract infection | 10 (2.7) |
Dizziness | 9 (2.5) |
Nausea | 6 (1.6) |
Fall | 6 (1.6) |
Fatigue | 5 (1.4) |
Somnolence | 5 (1.4) |
Dry mouth | 4 (1.1) |
Gastroesophageal reflux disease | 4 (1.1) |
Agitation | 4 (1.1) |
Peripheral edema | 4 (1.1) |