Table 3 Reported adverse events in mITTb population during follow-up.
Adverse events (AE) | EPP-AF (n = 98) | Placebo (n = 90) | p valuea |
|---|---|---|---|
Patients with at least one reported AE | 9/98 (9.2%) | 2/90 (2.2%) | 0.085 |
Headache | 1/98 (1.0%) | 0/90 (0%) | 1 |
Nausea | 2/98 (2.0%) | 0/90 (0%) | 0.515 |
Rash | 1/98 (1.0%) | 0/90 (0%) | 1 |
Itching | 2/98 (2.0%) | 0/90 (0%) | 0.515 |
Epigastralgia | 2/98 (2.0%) | 1/90 (1.1%) | 1 |
Pollakiuria | 0/98 (0%) | 1/90 (1.1%) | 1 |
Gastroesophageal reflux | 1/98 (1.0%) | 0/90 (0%) | 1 |