Table 2 Adverse events classified by organ system according to WHO Adverse Reaction Terminology
System organ class | No. (%) [n = 243]a | Preferred term(n) |
|---|---|---|
Skin and appendages disorders | 126(51.85) | Urticaria (37), rash maculo-papular (31), rash (18), pruritus (16), rash erythematous (8), dermatitis exfoliative (1), skin exfoliation (2), Steven Johnson syndrome (1), sweating increased (2), acute generalized exanthematous pustulosis (1), bullous eruption (1), eosinophillia (1), fixed eruption (1), stomatitis ulcerative (1), purpura allergic (1), flushing (1) |
Body as a whole-general disorders | 57(23.46) | Face oedema (19), angioedema (4), anaphylactic shock(5), anaphylactic reaction (4), fatigue (6), oedema mouth (5), fever (3), chest pain (3), oedema (2), oedema periorbital (1), therapeutic response decreased (2), back pain (1), oedema peripheral(3), pain(1) |
Gastrointestinal system disorders | 22(9.05) | Nausea (8), vomiting (4), abdominal pain (2), diarrhea (1), gastro-intestinal disorder non-specific (1), lipsdry (1), stomatitis (1), melaena (1), mouth dry (1) |
Respiratory system disorders | 15(6.17) | Dyspnoea (6), coughing (6), bronchospasm (2), sputum increased (1) |
Psychiatric disorders | 8(3.29) | Anorexia (4), somnolence (3), insomnia(1) |
Central and peripheral nervous system disorders | 7(2.88) | Headache (3), dysaethesia (2), dizziness(2) |
Musculoskeleton system disorders | 3(1.23) | Muscle weakness (2), paralysis (1) |
Vascular (extra cardiac) disorders | 1(0.41) | Vasculitis (1) |
Liver and biliary system disorders | 1(0.41) | Hepatitis(1) |
Urinary system disorders | 1(0.41) | Urinary frequency (1) |
Various | 2(0.82) | Anaesthesia local (1), anaesthesia mouth(1) |