Table 4 Classification of ADR (n = 246)
ADR according to SOC | Incidence of ADR | Time to onset | ||
|---|---|---|---|---|
Acute (within 60Â min) | Subacute (1 to 24Â h) | Latent (after 2Â days) | ||
Blood and lymphatic system disorders | ||||
    Anaemia | 2 (0.8%) | 0 | 1 | 1 |
Cardiac disorders | ||||
    QT prolongation | 34 (13.8%) | 0 | 9 | 25 |
    Bradycardia | 4 (1.6%) | 0 | 1 | 3 |
    ST elevation | 1 (0.4%) | 0 | 0 | 1 |
    Palpitation | 1 (0.4%) | 0 | 0 | 1 |
Gastrointestinal disorders | ||||
    Diarrhoea | 76 (30.9%) | 0 | 49 | 27 |
    Nausea and vomiting | 27 (11.0%) | 1 | 7 | 19 |
    Abdominal pain | 4 (1.6%) | 0 | 2 | 2 |
Hepatobiliary disorders | ||||
    Hyperbilirubinaemia (without jaundice) | 77 (31.3%) | 0 | 17 | 60 |
    Elevated liver transaminases | 6 (2.4%) | 0 | 0 | 6 |
    Hyperbilirubinaemia (with jaundice) | 5 (2.0%) | 0 | 3 | 2 |
    Elevated alkaline phosphatase | 1 (0.4%) | 0 | 0 | 1 |
Nervous system disorders | ||||
    Giddiness | 3 (1.2%) | 1 | 0 | 2 |
    Headache | 1 (0.4%) | 0 | 1 | 0 |
Renal and urinary disorders | ||||
    Acute kidney injury | 2 (0.8%) | 0 | 1 | 1 |
Skin and subcutaneous tissue disorders | ||||
    Rash | 2 (0.8%) | 0 | 1 | 1 |