Table 3.
Adverse events in the mITT population.
| Nitazoxanide (n = 202) | Placebo (n = 203) | P-valuea | |
|---|---|---|---|
| Number of participants with at least one adverse event, n (%) | 70 (35) | 70 (34) | 0.971 |
| Number of participants with two adverse events, n (%) | 20 (10) | 23 (11) | 0.641 |
| Number of participants with three or more adverse events, n (%) | 27 (13) | 21 (10) | 0.347 |
| Specific adverse events | |||
| Diarrheal, n (%) | 22 (11) | 18 (9) | 0.495 |
| Headache, n (%) | 33 (16) | 45 (22) | 0.137 |
| Nausea, n (%) | 19 (9) | 13 (6) | 0.263 |
| Abdominal pain, n (%) | 11 (5) | 14 (7) | 0.544 |
| Abnormal color of urine, n (%) | 8 (4) | 6 (3) | 0.580 |
| Vomiting, n (%) | 3 (1) | 0 (0) | 0.081 |
| Pruritus, n (%) | 2 (1) | 1 (0) | 0.559 |
| Urticaria, n (%) | 4 (2) | 4 (2) | 0.994 |
All adverse events reported after nitazoxanide or placebo.
a
p-value comparing proportions of adverse events between nitazoxanide and placebo.