Table 5 Frequency of adverse events during the study
Variable | Formulation A N = 17 | Formulation B N = 17 | p (Fisher's test) | |
|---|---|---|---|---|
Adverse events | Yes | 11 (64.7%) | 12 (70.6%) | 1.00 |
No | 6 (35.3%) | 5 (29.4%) | ||
Specific adverse event | Chest pain | 0 | 1 (5.9%) | 0.50 |
TGP increase | 1 (5.9%) | 0 | 0.50 | |
Tachycardia | 1 (5.9%) | 4 (23.5%) | 0.17 | |
Headache | 4 (23.5%) | 3 (17.6%) | 0.50 | |
Abdominal pain | 0 | 1 (5.9%) | 0.50 | |
Asthenia | 1 (5.9%) | 3 (17.6%) | 0.30 | |
Diarrhea | 0 | 2 (3.6%) | 0.24 | |
Dyspnea | 0 | 2 (3.6%) | 0.24 | |
Somnolence | 0 | 1 (1.8%) | 0.50 | |
Neck pain | 1 (5.9%) | 0 | 0.50 | |
Hypertension | 6 (35.3%) | 4 (23.5%) | 0.35 | |
Pain at site of injection | 6 (35.3%) | 6 (35.3%) | 1.00 | |
Bone pain | 0 | 1 (5.9%) | 0.50 | |
Edema | 0 | 6 (35.3%) | 0.009* | |
Fever | 2 (11.8%) | 5 (29.4%) | 0.20 | |
Hypotension | 5 (29.4%) | 2 (11.8%) | 0.20 | |
General malaise | 1 (5.9%) | 1 (5.9%) | 0.50 | |
Pneumonia | 0 | 1 (5.9%) | 0.50 | |
Pruritus | 1 (5.9%) | 3 (17.6%) | 0.30 | |
Chills | 2 (11.8%) | 2 (11.8%) | 0.70 | |
Vomiting | 3 (17.6%) | 6 (35.3%) | 0.22 | |