Table S1.
Patient disposition by completion of treatment and completion of study in the pooled 12-week, placebo-controlled studies, by LABA subgroup (ITT population)
| LABA | Placeboa
|
GLY 25 µg BID
|
GLY 50 µg BID
|
|||
|---|---|---|---|---|---|---|
| Yes (n=132) | No (n=298) | Yes (n=135) | No (n=296) | Yes (n=135) | No (n=297) | |
| Completed treatment, n (%) | 106 (80) | 247 (83) | 121 (90) | 256 (86) | 113 (84) | 268 (90) |
| Primary reason for discontinuation, n (%) | ||||||
| AE | 11 (8) | 28 (9) | 6 (4) | 17 (6) | 6 (4) | 13 (4) |
| Lack of efficacy | 3 (2) | 3 (1) | 3 (2) | 0 | 5 (4) | 0 |
| Non-compliance with study medication | 1 (1) | 1 (0.3) | 0 | 2 (1) | 0 | 0 |
| Protocol violation | 0 | 1 (0.3) | 0 | 0 | 0 | 0 |
| Other | 11 (8) | 18 (6) | 5 (4) | 21 (7) | 11 (8) | 16 (5) |
|
| ||||||
| Completed the study, n (%) | 112 (85) | 267 (90) | 128 (95) | 268 (91) | 123 (91) | 277 (93) |
| Primary reason for discontinuation, n (%) | ||||||
| Death | 0 | 0 | 0 | 0 | 0 | 1 (0.3) |
| Withdrawal by subject | 15 (11) | 22 (7) | 5 (4) | 15 (5) | 7 (5) | 12 (4) |
| Lost to follow-up | 2 (2) | 3 (1) | 0 | 8 (3) | 2 (1) | 4 (1) |
| Other | 3 (2) | 6 (2) | 2 (1) | 5 (2) | 3 (2) | 3 (1) |
Note:
a
One subject was randomized but discontinued before study treatment.
Abbreviations: AE, adverse event; BID, twice daily; GLY, glycopyrrolate inhalation solution; ITT, intent-to-treat; LABA, long-acting beta2-agonist.