Table 4 Treatment-emergent AEs, overall and by preferred term (≥2.5 % with either treatment) (safety set)
IND/GLY (N = 193) | Placebo (N = 188) | |||
|---|---|---|---|---|
Events, n | Patients, n (%) | Events, n | Patients, n (%) | |
All TEAEs | 73 | 44 (22.8) | 48 | 43 (22.9) |
Cough | 8 | 8 (4.1) | 3 | 3 (1.6) |
Nasopharyngitis | 7 | 7 (3.6) | 8 | 8 (4.3) |
Headache | 7 | 6 (3.1) | 3 | 3 (1.6) |
Suspected related TEAEs | 12 | 11 (5.7) | 4 | 4 (2.1) |
Cough | 5 | 5 (2.6) | 1 | 1 (0.5) |
Serious TEAEs | 4 | 4 (2.1) | 2 | 2 (1.1) |
Deaths | 1 | 1 (0.5) | 0 | 0 |
Suspected related serious TEAE | 0 | 0 | 0 | 0 |