Table 6.
Subjects with treatment-emergent adverse events by single- and multiple-dose period
| Dose schedule | AE (MedDRA® preferred term) | Placebo [n (%)] | Fidaxomicin [n (%)] | |||
|---|---|---|---|---|---|---|
| Japanese (n = 6) | Caucasian (n = 3) | Japanese 100 mg (n = 9) | Japanese 200 mg (n = 9) | Caucasian 200 mg (n = 9) | ||
| Single dosea | Overall | 1 (16.7) | 0 | 1 (11.1) | 0 | 1 (11.1) |
| Constipation | 0 | 0 | 1 (11.1) | 0 | 0 | |
| Diarrhea | 1 (16.7) | 0 | 0 | 0 | 0 | |
| Dermatitis contact | 0 | 0 | 0 | 0 | 1 (11.1) | |
| Multiple doseb | Overall | 1 (16.7) | 0 | 1 (11.1) | 1 (11.1) | 0 |
| Feeling hot | 0 | 0 | 0 | 1 (11.1) | 0 | |
| Hypersomnia | 1 (16.7) | 0 | 1 (11.1) | 0 | 0 | |
AE adverse event, MedDRA ® Medical Dictionary for Regulatory Activities
aSingle-dose period includes any AEs observed on or after the time of the Day 1 dose up until prior to the first dose in the multiple-dose period starting on Day 6
bMultiple-dose period includes any AEs observed on or after the time of the first dose on Day 6 until end of follow-up