Table 3.
Most common (≥2%) treatment-emergent adverse events by treatment group (safety population), severity, and study discontinuation
|
TEAEs |
NTG 0.4% |
Placebo |
|---|---|---|
| n (%) | (n = 123) | (n = 124) |
| Number of patients with ≥1 AE |
96 (78.0) |
67 (54.0) |
| Mild |
31 (25.2) |
15 (12.1) |
| Moderate |
41 (33.3) |
38 (30.6) |
| Severe |
24 (19.5) |
14 (11.3) |
| Headaches |
86 (69.9) |
59 (47.6) |
| Dizziness |
6 (4.9) |
2 (1.6) |
| Diarrhea |
4 (3.3) |
4 (3.2) |
| Nausea |
2 (1.6) |
5 (4.0) |
| Sinusitis |
3 (2.4) |
1 (0.8) |
| AEs leading to study discontinuation |
9 (7.3) |
4 (3.2) |
| Headache |
7 (5.7) |
1 (0.8) |
| Palpitations |
1 (0.8) |
0 |
| Celiac disease |
0 |
1 (0.8) |
| Diarrhea |
0 |
1 (0.8) |
| Skin fissures |
1 (0.8) |
0 |
| Pain of skin | 0 | 1 (0.8) |
Abbreviation: AE Adverse event, TEAE Treatment-emergent adverse event.