Table 3.
Most frequent treatment-emergent adverse events (≥2% in either treatment group) until week 12 in the safety population
| MedDRA PT (≥2%) | Nicotinamide + PB, n (%) (n=540) | Placebo + PB, n (%) (n=183) |
|---|---|---|
| Diarrhea | 166 (30.7) | 23 (12.6) |
| Pruritus | 53 (9.8) | 5 (2.7) |
| Nasopharyngitis | 39 (7.2) | 11 (6.0) |
| Nausea | 39 (7.2) | 6 (3.3) |
| Vomiting | 32 (5.9) | 7 (3.8) |
| Hypertension | 31 (5.7) | 7 (3.8) |
| Headache | 26 (4.8) | 6 (3.3) |
| Bronchitis | 24 (4.4) | 5 (2.7) |
| Anemia | 22 (4.1) | 4 (2.2) |
| Hypotension | 5 (0.9) | 7 (3.8) |
| Decreased appetite | 19 (3.5) | 4 (2.2) |
| Muscle spasms | 17 (3.1) | 6 (3.3) |
| Cough | 15 (2.8) | 3 (1.6) |
| Flatulence | 2 (0.4) | 5 (2.7) |
| Sleep disorder | 14 (2.6) | 3 (1.6) |
| Fatigue | 14 (2.6) | 0 (0.0) |
| Rash | 13 (2.4) | 1 (0.5) |
| Influenza | 7 (1.3) | 4 (2.2) |
| Arthralgia | 5 (0.9) | 4 (2.2) |
| Hypocalcaemia | 2 (0.4) | 4 (2.2) |
| Abdominal pain upper | 11 (2.0) | 1 (0.5) |
Treatment-emergent adverse event: defined as all adverse events that occurred between the first intake of study medication and the week 12 visit, withdrawal or permanent discontinuation of study medication.