Table 2.
Adverse events that led to changes in dosing or to temporary or permanent discontinuation
| Adverse events (AEs) in 979 men | ||
|---|---|---|
| Treatment-relateda | All causality | |
| Patients with AEs, n (%) | 37 (3.8) | 210 (21.5) |
| Discontinued because of AEs, n (%) | 11 (1.1) | 55 (5.6) |
| Most frequent (≥0.5%) AEs, n (%) | ||
| Headache | 10 (1.0) | 10 (1.0) |
| Dyspepsia | 10 (1.0) | 12 (1.2) |
| Rhinitis | 6 (0.6) | 6 (0.6) |
| Flushing | 5 (0.5) | 5 (0.5) |
| Coronary artery disorder | 0 | 24 (2.5) |
| Prostatic disorder | 0 | 16 (1.6) |
| Carcinoma | 0 | 14 (1.4) |
| Myocardial infarction | 0 | 11 (1.1)b |
| Arthritis | 0 | 9 (0.9) |
| Bone fracture accidental | 0 | 9 (0.9) |
| Accidental injury | 0 | 7 (0.7) |
| Cerebrovascular disorder | 0 | 7 (0.7) |
| Atrial fibrillation | 0 | 6 (0.6) |
| Cholecystitis | 0 | 6 (0.6) |
| Sepsis | 0 | 5 (0.5) |
| Heart failure | 0 | 5 (0.5) |
| Gastrointestinal carcinoma | 0 | 5 (0.5) |
| Bone disorder | 0 | 5 (0.5) |
a
Other treatment-related AEs were abnormal vision (n = 4), dizziness (n = 3), and 1 report each of mild palpitations, moderate tachycardia, diarrhea, nausea, myalgia, hypertonia, respiratory disorder, conjunctivitis, and photophobia.
b
Because serious adverse events are collected for a longer period (30 days after the completion of treatment) than adverse events in general, numbers of events may vary between these 2 databases.