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) |