System organ class | Adverse event | Number of adverse events | Risk (per 1000 patients) |
---|---|---|---|
Gastrointestinal disorders | Abdominal pain | 187 | 31.2 |
Anorexia | 442 | 73.7 | |
Diarrhoea | 371 | 61.8 | |
Nausea/vomiting | 471 | 78.5 | |
Others | 109 | 18.2 | |
General disorders | Weakness | 372 | 62 |
Pyrexia | 372 | 62 | |
Mouth ulcer | 13 | 2.2 | |
Salivation | 7 | 1.2 | |
Unable to suck | 5 | 0.8 | |
Body pain | 10 | 1.7 | |
Hypersensitivity reaction | 3 | 0.5 | |
Puffy face | 1 | 0.2 | |
Respiratory disorders | Cough | 1152 | 192 |
Coryza | 449 | 74.8 | |
Dyspnoea | 4 | 0.7 | |
Others | 55 | 9.2 | |
Central Nervous system disorders | Headache | 228 | 38 |
Dizziness | 18 | 3 | |
Insomnia | 23 | 3.8 | |
Convulsion | 3 | 0.5 | |
Nystagmus | 1 | 0.2 | |
Skin and appendages disorders | Rash | 55 | 9.2 |
Pruritus | 90 | 15 | |
Urticaria | 2 | 0.3 | |
Others | 35 | 5.8 | |
Haematological disorders | Anaemia | 157 | 26.2 |
Haemolysis | 3 | 0.5 | |
Thrombocytopaenia | 9 | 1.5 | |
Neutropenia | 42 | 7 | |
Liver and biliary system disorders | Jaundice | 3 | 0.5 |
Elevated ALT | 23 | 3.8 | |
Hepatomegaly | 4 | 0.7 | |
Musculo-skeletal system disorders | Joint pain | 1 | 0.2 |
Cardiovascular disorders | Palpitation | 6 | 1 |