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) |