Table 4.
Reported AEs during the study.
| Reported adverse event | Number of AEs (n, %) | ||
|---|---|---|---|
| (System organ class) | Active reporting (N = 973) | Spontaneous reporting (n = 276) | p value |
| Application site disorders | 367 (37.7%) | 85 (30.8%) | 0.017 |
| Pain | 211 (21.7%) | 46 (16.7%) | |
| Injection site reaction | 94 (9.7%) | 14 (5.1%) | |
| Tumefaction | 22 (2.3%) | 20 (7.2%) | |
| Oedema | 20 (2.0%) | 2 (0.7%) | |
| Induration | 20 (2.0%) | 3 (1.1%) | |
| General disorder | 288 (29.5%) | 83 (30.1%) | NS |
| Fever | 162 (16.6%) | 61 (22.1%) | |
| Shivering | 59 (6.1%) | 15 (5.4%) | |
| Asthenia | 40 (1.4%) | 5 (1.8%) | |
| Fatigue | 20 (2.0%) | 2 (0.7%) | |
| Ache | 7 (0.7%) | 0 (0.0%) | |
| Central and peripheral nervous system disorders | 198 (20.3%) | 134 (48.6%) | <0.0001 |
| Headache | 94 (9.7%) | 39 (14.1%) | |
| Influenza syndrome | 45 (4.6%) | 45 (16.3%) | |
| Vertigo | 31 (3.2%) | 41 (14.8%) | |
| Paraesthesia | 20 (2.0%) | 8 (2.9%) | |
| Sleep disorders | 8 (0.8%) | 1 (0.4%) | |
| Discomfort | 5 (0.5%) | 0 (0.0%) | |
| Musculoskeletal system disorders | 58 (6.0%) | 33 (12.0%) | 0.0004 |
| Myalgia | 22 (2.3%) | 28 (10.1%) | |
| Athralgia | 19 (1.9%) | 3 (1.1%) | |
| Musculoskeletal pain | 14 (1.4%) | 0 (0.0%) | |
| Others | 3 (0.3%) | 2 (0.7%) | |
| Gastrointestinal system disorders | 26 (2.6%) | 31 (11.2%) | <0.0001 |
| Abdominal pain | 2 (0.2%) | 4 (1.4%) | |
| Diarrhoea | 8 (0.8%) | 12 (4.3%) | |
| Nausea | 14 (1.4%) | 0 (0.0%) | |
| Vomiting | 2 (0.2%) | 15 (5.4%) | |
| Cardiovascular disorders | 10 (1.0%) | 5 (1.8%) | NS |
| Respiratory system disorders | 10 (1.0%) | 7 (2.5%) | 0.028 |
| Skin and appendages disorders | 8 (0.8%) | 21 (7.6%) | <0.0001 |
| Vision disorders | 3 (0.3%) | 0 (0.0%) | NA |
| Reproductive disorders, female | 2 (0.2%) | 0 (0.0%) | NA |
| Psychiatric disorders | 1 (0.1%) | 1 (0.4%) | NA |
NA, not applicable; NS, not significant.