Table 4. Incidence and severity of treatment-emergent AEs (⩾5% of subjects).
| Adverse eventa |
Leuprolide acetate 45 mg 6-month depot (N=151) |
|||
|---|---|---|---|---|
| All events, n (%) |
Severityb |
|||
| Mild | Moderate | Severe | ||
| Hot flush | 88 (58.3) | 58 | 23 | 7 |
| Injection site pain | 27 (17.9) | 22 | 5 | 0 |
| Fatigue | 18 (11.9) | 15 | 2 | 1 |
| Constipation | 15 (9.9) | 9 | 6 | 0 |
| Arthralgia | 14 (9.3) | 8 | 6 | 0 |
| Insomnia | 13 (8.6) | 12 | 1 | 0 |
| Headache | 11 (7.3) | 6 | 4 | 1 |
| Cough | 10 (6.6) | 7 | 3 | 0 |
| Hematuria | 10 (6.6) | 7 | 3 | 0 |
| Nasopharyngitis | 10 (6.6) | 6 | 4 | 0 |
| Dysuria | 9 (6.0) | 7 | 2 | 0 |
| Hypertension | 9 (6.0) | 3 | 6 | 0 |
| Rash | 9 (6.0) | 8 | 1 | 0 |
| Anemia | 8 (5.3) | 6 | 1 | 1 |
| Back pain | 8 (5.3) | 4 | 4 | 0 |
| Chronic obstructive pulmonary disease | 8 (5.3) | 3 | 2 | 3 |
| Dizziness | 8 (5.3) | 6 | 2 | 0 |
| Musculoskeletal pain | 8 (5.3) | 7 | 1 | 0 |
| Nocturia | 8 (5.3) | 5 | 3 | 0 |
| Upper respiratory tract infection | 8 (5.3) | 4 | 4 | 0 |
| Urinary tract infection | 8 (5.3) | 4 | 3 | 1 |
Abbreviation: AEs, adverse events.
a
Coded using MedDRA 12.0 Preferred Term.
b
Subjects were counted for most severe event, as assessed by the investigator, for each preferred term.