Table 3.
Summary of Adverse events by category and preferred term (SS)
| MedDRA system organ class Preferred terms | F-627 (N = 120), n (%) | Filgrastim (N = 119), n (%) |
|---|---|---|
| AEs | 119 (99.2) | 119 (100) |
| Gastrointestinal disorders | ||
| Nausea | 104 (86.7) | 102 (85.7) |
| Vomiting | 76 (63.3) | 89 (74.8) |
| Constipation | 17 (14.2) | 17 (14.3) |
| Abdominal Distension | 14 (11.7) | 8 (6.7) |
| Investigations | ||
| White blood cell count decreased | 79 (65.8) | 99 (83.2) |
| Neutrophil count decreased | 71 (59.2) | 99 (83.2) |
| Platelet count decreased | 56 (46.7) | 40 (33.6) |
| Alanine aminotransferase increased | 36 (30.0) | 19 (16.0) |
| Aspartate aminotransferase increased | 30 (25.0) | 14 (11.8) |
| Skin and subcutaneous tissue disorders | ||
| Alopecia | 93 (77.5) | 83 (69.7) |
| Blood and lymphatic system disorders | ||
| Anemia | 81 (67.5) | 79 (66.4) |
| Musculoskeletal and connective tissue disorders | ||
| Bone pain | 30 (25.0) | 40 (33.6) |
| Back pain | 19 (15.8) | 28 (23.5) |
| General disorders and administration site conditions | ||
| Asthenia | 42 (35.0) | 35 (29.4) |
| Metabolism and nutrition disorders | ||
| Decreased appetite | 29 (24.2) | 30 (25.2) |
| Nervous system disorders | ||
| Headache | 7 (5.8) | 15 (12.6) |
| Dizziness | 8 (6.7) | 14 (11.8) |
| Ear and labyrinth disorders | ||
| Vertigo | 27 (22.5) | 21 (17.6) |
| Infections and infestations | ||
| Upper respiratory tract infection | 14 (11.7) | 16 (13.4) |
| Psychiatric disorders | ||
| Insomnia | 14 (11.7) | 16 (13.4) |
Abbreviations: SS Safety Analysis Set, AEs Adverse events, SAEs Serious adverse events
N: Number of patients; n: Number of patients with at least one event