Table 2.
Patient disposition by study and for the merged full analysis set
| Status | CONFIDENCE II (N = 1253) |
PROTECT I (N = 988) |
STH I (N = 552) |
STH II (N = 379) |
Merged FAS (N = 3172) |
|---|---|---|---|---|---|
| Withdrawn, n (%) | 35 (2.8) | 24 (2.4) | 0 (0.0) | 22 (5.8) | 81 (2.5) |
| Withdrew consent | 5 (0.4) | 1 (0.1) | 0 (0.0) | 1 (0.3) | 7 (0.2) |
| Adverse event | 23 (1.8) | 17 (1.7) | 0 (0.0) | 17 (4.5) | 57 (1.8) |
| Lack of drug efficacy | 1 (0.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.03) |
| Protocol violation | 1 (0.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.03) |
| Non-compliance | 1 (0.1) | 2 (0.2) | 0 (0.0) | 1 (0.3) | 4 (0.1) |
| Other | 4 (0.3) | 4 (0.4) | 0 (0.0) | 3 (0.8) | 11 (0.3) |
| Lost to follow up, n (%) | 121 (9.7) | 65 (6.6) | 78 (14.1) | 45 (11.8) | 309 (9.7) |
| Completed, n (%) | 1097 (87.5) | 899 (91.0) | 474 (85.9) | 312 (82.3) | 2782 (87.7) |
FAS full analysis set, STH Shake the Habit