Table 2 Patients Experiencing TEAEs During Long-term Treatment With GXR
Variable | Former placebo patients (N = 88) | Former GXR patients (N = 62) | New patients (N = 41) | All patients (N = 191) |
|---|---|---|---|---|
All TEAEs, n (%) | 82 (93.2) | 58 (93.5) | 40 (97.6) | 180 (94.2) |
Related | 74 (84.1) | 49 (79.0) | 37 (90.2) | 160 (83.8) |
Milda | 46 (52.3) | 39 (62.9) | 20 (48.8) | 105 (50.0) |
Moderatea | 35 (39.8) | 17 (27.4) | 20 (48.8) | 72 (37.7) |
Severea | 1 (1.1) | 2 (3.2) | 0 | 3 (1.6) |
Leading to study discontinuation, n (%) | 22 (25.0) | 6 (9.7) | 10 (24.4) | 38 (19.9) |
Serious TEAEs, n (%) | 0 | 1 (1.6) | 1 (2.4) | 2 (1.0) |
Death, n (%) | 0 | 0 | 0 | 0 |
TEAEs occurring in ≥10% of all patients, n (%) | ||||
Somnolence | 34 (38.6) | 27 (43.5) | 19 (46.3) | 80 (41.9) |
Thirst | 34 (38.6) | 13 (21.0) | 12 (29.3) | 59 (30.9) |
Nasopharyngitis | 19 (21.6) | 20 (32.3) | 14 (34.1) | 53 (27.7) |
Blood pressure decrease | 16 (18.2) | 11 (17.7) | 11 (26.8) | 38 (19.9) |
Postural dizziness | 18 (20.5) | 8 (12.9) | 10 (24.4) | 36 (18.8) |
Bradycardia | 16 (18.2) | 10 (16.1) | 7 (17.1) | 33 (17.3) |
Malaise | 17 (19.3) | 6 (9.7) | 7 (17.1) | 30 (15.7) |
Constipation | 8 (9.1) | 7 (11.3) | 6 (14.6) | 21 (11.0) |
Dizziness | 13 (14.8) | 5 (8.1) | 2 (4.9) | 20 (10.5) |