Table 2 Patients withdrawals during the 1-year treatment period
AE, n (%) | Lost to follow-up, n (%) | Physician decision, n (%) | Protocol deviation, n (%) | Withdrawal by subject, n (%) | Other, n (%) | Total, n (%) | |
|---|---|---|---|---|---|---|---|
Revefenacin 88 μg | (n = 368) | ||||||
Days 1–30 | 11 (3.0) | – | 1 (0.3) | – | 9 (2.4) | – | 21 (5.7) |
Days 31–92 | 11 (3.0) | 3 (0.8) | – | – | 15 (4.1) | – | 29 (7.9) |
Days 93–183 | 11 (3.0) | 7 (1.9) | 2 (0.5) | 1 (0.3) | 25 (6.8) | 1 (0.3) | 47 (12.8) |
Days 184–274 | 7 (1.9) | 6 (1.6) | – | 1 (0.3) | 13 (3.5) | 1 (0.3) | 28 (7.6) |
Days 275–364 | 7 (1.9) | 5 (1.4) | – | – | 8 (2.2) | – | 20 (5.4) |
Total | 47 (12.8) | 21 (5.7) | 3 (0.8) | 2 (0.5) | 70 (19.0) | 2 (0.5) | 145 (39.4) |
Revefenacin 175 μg | (n = 335) | ||||||
Days 1–30 | 6 (1.8) | 1 (0.3) | – | – | 11 (3.3) | – | 18 (5.4) |
Days 31–92 | 11 (3.3) | 2 (0.6) | – | – | 28 (8.4) | 1 (0.3) | 42 (12.5) |
Days 93–183 | 11 (3.3) | 5 (1.5) | 2 (0.6) | – | 24 (7.2) | – | 42 (12.5) |
Days 184–274 | 6 (1.8) | 5 (1.5) | – | – | 10 (3.0) | – | 21 (6.3) |
Days 275–364 | 8 (2.4) | 4 (1.2) | 1 (0.3) | – | 7 (2.1) | 1 (0.3) | 21 (6.3) |
Total | 42 (12.5) | 17 (5.1) | 3 (0.9) | – | 80 (23.9) | 2 (0.6) | 144 (43.0) |
Tiotropium 18 μg | (n = 357) | ||||||
Days 1–30 | 3 (0.8) | – | – | – | 3 (0.8) | – | 6 (1.7) |
Days 31–92 | 6 (1.7) | 2 (0.6) | – | 1 (0.3) | 10 (2.8) | – | 19 (5.3) |
Days 93–183 | 8 (2.2) | 3 (0.8) | – | – | 14 (3.9) | – | 25 (7.0) |
Days 184–274 | 7 (2.0) | 5 (1.4) | – | – | 9 (2.5) | – | 21 (5.9) |
Days 275–364 | 9 (2.5) | 5 (1.4) | 1 (0.3) | – | 7 (2.0) | 1 (0.3) | 23 (6.4) |
Total | 33 (9.2) | 15 (4.2) | 1 (0.3) | 1 (0.3) | 43 (12.0) | 1 (0.3) | 94 (26.3) |