Table 3.
Reported adverse events during the study
| System organ class and preferred term | Intensive GMA (N = 54) | Weekly GMA (N = 45) | Total |
|---|---|---|---|
| Nervous system disorder | 8 (8.1) | ||
| Headache | 2 (3.7) | 5 (11.1) | |
| Dizziness | 1 (1.9) | 0 (0.0) | |
| General disorders and administration site condition | 4 (4.0) | ||
| Pyrexia | 2 (3.7) | 1 (2.2) | |
| Chest pain | 1 (1.9) | 0 (0.0) | |
| Gastrointestinal disorders | 2 (2.0) | ||
| Abdominal pain | 0 (0.0) | 1 (2.2) | |
| Diarrhea | 0 (0.0) | 1 (2.2) | |
| Cardiac disorders | 2 (2.0) | ||
| Palpitations | 1 (1.9) | 0 (0.0) | |
| Coldness/Bradycaridia | 1 (1.9) | 0 (0.0) | |
| Musculoskeletal connective tissue disorders | 2 (2.0) | ||
| Arthralgia | 0 (0.0) | 1 (2.2) | |
| Myalgia | 1 (1.9) | 0 (0.0) | |
| Vascular disorders | 2 (2.0) | ||
| Hot flashes | 0 (0.0) | 1 (2.2) | |
| Hypotension | 1 (1.9) | 0 (0.0) | |
| Blood and lymphatic system disorders | 1 (1.0) | ||
| Leukopenia | 0 (0.0) | 1 (2.2) | |
| Ear and labyrinth disorders | 1 (1.0) | ||
| Ear fullness | 1 (1.9) | 0 (0.0) | |
| Total | 11 (20.4) | 11 (24.4) | 22 (22.2) |
Values are the patient’s number (%)