Table 5.
AE, n (%) | Number of AEs | Number of patients, N=296 |
---|---|---|
Clostridium difficile infectiona | 45 | 41 (13.9) |
Drug ineffectiveb | 14 | 13 (4.4) |
General physical health deterioration | 10 | 9 (3.0) |
Death | 8 | 8 (2.7) |
Diarrhoea | 4 | 4 (1.4) |
Renal failure acute | 4 | 4 (1.4) |
Cardiac failure | 3 | 3 (1.0) |
Respiratory failure acute | 3 | 3 (1.0) |
Septic shock | 3 | 3 (1.0) |
Agranulocytosis | 2 | 2 (0.7) |
Lung disorder | 3 | 2 (0.7) |
Clostridium difficile colitis | 2 | 2 (0.7) |
Colitis | 2 | 2 (0.7) |
Intestinal obstruction | 2 | 2 (0.7) |
Rash | 2 | 2 (0.7) |
Respiratory distress | 2 | 2 (0.7) |
Respiratory distress syndrome, acute | 2 | 2 (0.7) |
aReported at any point during the study, regardless of treatment timing. bNo improvement in diarrhoea symptoms. AE, adverse event; n, number of patients with stated AEs; N, number of fidaxomicin-treated patients.