Table 3 Reasons for study discontinuation for all ITT patients in the overall population
p-value | |||||||||
|---|---|---|---|---|---|---|---|---|---|
Variable | PBO N = 295 n (%) | LY40 N = 292 n (%) | LY80 N = 280 n (%) | RIS N = 142 n (%) | Total N = 1009 n (%) | Overall | LY40 vs. PBO | LY80 vs. PBO | RIS vs. PBO |
Completed | 171 (58.0) | 143 (49.0) | 129 (46.1) | 96 (67.6) | 539 (53.4) | <.001 | 0.032 | 0.005 | 0.059 |
Discontinued | |||||||||
Adverse Event-Physician Decision | 24 (8.1) | 18 (6.2) | 29 (10.4) | 10 (7.0) | 81 (8.0) | 0.322 | 0.424 | 0.389 | 0.849 |
Adverse Event-Subject Decision | 9 (3.1) | 6 (2.1) | 7 (2.5) | 2 (1.4) | 24 (2.4) | 0.770 | 0.603 | 0.802 | 0.515 |
Entry Criteria Not Met | 1 (0.3) | 1 (0.3) | 0 (0.0) | 0 (0.0) | 2 (0.2) | >.999 | >.999 | >.999 | >.999 |
Lost to follow up | 9 (3.1) | 4 (1.4) | 6 (2.1) | 3 (2.1) | 22 (2.2) | 0.576 | 0.262 | 0.604 | 0.759 |
Perceived Lack of Efficacy-Physician Decision | 39 (13.2) | 56 (19.2) | 57 (20.4) | 7 (4.9) | 159 (15.8) | <.001 | 0.057 | 0.025 | 0.007 |
Perceived Lack of Efficacy-Subject Decision | 9 (3.1) | 14 (4.8) | 12 (4.3) | 3 (2.1) | 38 (3.8) | 0.499 | 0.296 | 0.508 | 0.759 |
Protocol Violation | 5 (1.7) | 10 (3.4) | 7 (2.5) | 3 (2.1) | 25 (2.5) | 0.616 | 0.202 | 0.568 | 0.718 |
Scheduling Conflict | 1 (0.3) | 1 (0.3) | 0 (0.0) | 0(0.0) | 2 (0.2) | >.999 | >.999 | >.999 | >.999 |
Sponsor Decision | 1 (0.3) | 1 (0.3) | 1 (0.4) | 0 (0.0) | 3 (0.3) | >.999 | >.999 | >.999 | >.999 |
Subject Decision-Consent Withdrawn | 26 (8.8) | 33 (11.3) | 30 (10.7) | 18 (12.7) | 107 (10.6) | 0.596 | 0.339 | 0.483 | 0.235 |
Subject is Moving or has Moved | 0 (0.0) | 4 (1.4) | 1 (0.4) | 0 (0.0) | 5 (0.5) | 0.082 | 0.061 | 0.487 | |
Transportation Issues | 0 (0.0) | 1 (0.3) | 1 (0.4) | 0 (0.0) | 2 (0.2) | 0.668 | 0.497 | 0.487 | |