Table 10 Adverse events and advers drug reaction (SAF)
N = 69 | ||||
|---|---|---|---|---|
System Organ Class | AEs | (%) | ADRs | (%) |
Preferred Term | ||||
Overall | 14 | (20.3) | 2 | (2.9) |
Infections and Infestations | 5 | (7.2) | 0 | (0.0) |
Nasopharyngitis | 4 | (5.8) | 0 | (0.0) |
Otitis media | 1 | (1.4) | 0 | (0.0) |
Immune system disorders | 1 | (1.4) | 1 | (1.4) |
Hypersensitivity | 1 | (1.4) | 1 | (1.4) |
Respiratory, thoracic and mediastinal disorders | 1 | (1.4) | 0 | (0.0) |
Upper respiratory tract inflammation | 1 | (1.4) | 0 | (0.0) |
Gastrointestinal disorders | 1 | (1.4) | 1 | (1.4) |
Breath odour | 1 | (1.4) | 1 | (1.4) |
Hepatobiliary disorders | 1 | (1.4) | 0 | (0.0) |
Hepatic function abnormal | 1 | (1.4) | 0 | (0.0) |
Skin and subcutaneous tissue disorders | 1 | (1.4) | 1 | (1.4) |
Eczema | 1 | (1.4) | 1 | (1.4) |
Renal and urinary disorders | 1 | (1.4) | 0 | (0.0) |
Hypertonic bladder | 1 | (1.4) | 0 | (0.0) |
General disorders and administration site conditions | 1 | (1.4) | 0 | (0.0) |
Pyrexia | 1 | (1.4) | 0 | (0.0) |
Investigations | 5 | (7.2) | 0 | (0.0) |
Gamma-glutamyltransferase increased | 2 | (2.9) | 0 | (0.0) |
Blood pressure increased | 1 | (1.4) | 0 | (0.0) |
Glucose urine present | 1 | (1.4) | 0 | (0.0) |
Blood alkaline phosphatase increased | 1 | (1.4) | 0 | (0.0) |