Table 2.
Summary of adverse events
| Adverse events | RCT placebo treatment (n = 82; PYE = 26.6) | OLM study 6-month rifaximin treatment (n = 82; PYE = 36.4) |
|---|---|---|
| Most common AEs*, n (rate†) | ||
| Ascites | 5 (0.19) | 9 (0.27) |
| Headache | 9 (0.38) | 0 (0.0) |
| Nausea | 11 (0.47) | 9 (0.26) |
| Peripheral oedema | 9 (0.36) | 10 (0.29) |
| Infection-related AEs‡, n (rate†) | ||
| Cellulitis | 2 (0.08) | 6 (0.17) |
| Peritonitis | 3 (0.11) | 2 (0.06) |
| Pneumonia | 0 (0.0) | 3 (0.08) |
| Sepsis/septic shock | 2 (0.08) | 3 (0.08) |
| Urinary tract/kidney infection | 7 (0.29) | 5 (0.14) |
AE, adverse event; PYE, person-years of exposure; RCT, randomised, controlled trial.
*
Reported in ≥10% of patients during therapy with either treatment.
†
AE rates were calculated as number of patients with an event ÷ PYE, in which PYE reflected exposure up until the AE occurrence and, therefore, may have differed from the PYE for the entire patient group.
‡
Reported in ≥2 patients during therapy with either treatment. Peritonitis included bacterial peritonitis. Pneumonia included lobar pneumonia. Sepsis/septic shock included bacteremia, Escherichia bacteremia, fungemia, Klebsiella bacteremia, Staphylococcus bacteremia and urosepsis.