AE with possible relation | SAE | |||
---|---|---|---|---|
Event | % | Event | No of events (no of patients) | Attribution |
Oedema | 80 | Haematuria (hospitalisations) | 7 (1) | Not related |
Nausea | 73 | Pneumonia | 2 (2) | Unlikely |
Myalgias | 67 | C difficile infection | 2 (1) | Not related |
CK elevation | 43 | Infected ulcer | 2 (2) | Unlikely |
Fatigue | 40 | Death (pneumonia) | 1 (1) | Not related |
Anaemia | 27 | Acute gastroenteritis | 1 (1) | Not related |
Pyrosis | 13 | Acute myocardial infarction | 1 (1) | Not related |
Vomiting | 13 | Anaemia blood transfusion | 1 (1) | Not related |
Weight loss | 13 | Fall | 1 (1) | Not related |
Headaches | 13 | Fluid overload | 1 (1) | Probably |
Effusions | 10 | Rectal prolapse, haemorrhoidal bleed | 1 (1) | Unlikely |
Hypocalcemia | 7 | Nephrolithiasis | 1 (1) | Not related |
Dry skin | 7 | Partial small bowel obstruction | 1 (1) | Not related |
Erectile dysfunction | 7 | Bleeding post renal biopsy (hospitalisation) | 1 (1) | Not related |
Generalised weakness | 7 | Tachyarrhythmia/cardiomyopathy | 1 (1) | Possibly |
Light-headedness | 7 |
AE, adverse event; CK, creatine kinase; SAE, serious adverse event.