Table 4 Summary of TEAEs (safety population)
Parameter | GP MDI 28.8 μg BID, N = 49 | GP MDI 14.4 μg BID, N = 49 | GP MDI 7.2 μg BID, N = 49 | GP MDI 3.6 μg BID, N = 45 | Placebo MDI BID, N = 48 | Ipratropium MDI 34 μg QID, N = 48 | All patients, N = 103 |
|---|---|---|---|---|---|---|---|
Patients with at least one TEAE, n (%) | 7 (14.3) | 11 (22.4) | 14 (28.6) | 10 (22.2) | 7 (14.6) | 15 (31.3) | 45 (43.7) |
Patients with TEAEs related to study treatment, n (%) | 3 (6.1) | 4 (8.2) | 7 (14.3) | 6 (13.3) | 3 (6.3) | 7 (14.6) | 21 (20.4) |
Patients with SAEs, n (%) | 0 | 0 | 0 | 1 (2.2) | 0 | 1 (2.1) | 2 (1.9) |
TEAEs reported in ≥2% of patients for any treatment arm, n (%) (preferred term) | |||||||
Dry mouth | 1 (2.0) | 2 (4.1) | 4 (8.2) | 4 (8.9) | 1 (2.1) | 3 (6.3) | 12 (11.7) |
Cough | 1 (2.0) | 2 (4.1) | 2 (4.1) | 0 | 0 | 3 (6.3) | 6 (5.8) |
Headache | 1 (2.0) | 1 (2.0) | 1 (2.0) | 2 (4.4) | 0 | 0 | 4 (3.9) |
Diarrhea | 1 (2.0) | 0 | 1 (2.0) | 0 | 0 | 1 (2.1) | 3 (2.9) |
Dyspnea | 0 | 1 (2.0) | 0 | 0 | 2 (4.2) | 0 | 3 (2.9) |
Hypertension | 0 | 0 | 2 (4.1) | 1 (2.2) | 0 | 0 | 3 (2.9) |
Nasopharyngitis | 0 | 1 (2.0) | 1 (2.0) | 0 | 0 | 1 (2.1) | 3 (2.9) |
Oropharyngeal pain | 0 | 1 (2.0) | 0 | 0 | 0 | 2 (4.2) | 3 (2.9) |
Pyrexia | 0 | 0 | 0 | 0 | 1 (2.1) | 2 (4.2) | 3 (2.9) |
Vomiting | 1 (2.0) | 0 | 1 (2.0) | 1 (2.2) | 1 (2.1) | 1 (2.1) | 3 (2.9) |