Table 3.
Patient disposition | Duloxetine (N = 1555) | Placebo (N = 1206) | p-value |
---|---|---|---|
Early discontinuation, n (%) | 371 (23.9) | 344 (28.5) | 0.005 |
Reasons for early discontinuations,n (%) | |||
Adverse events | 126 (8.1) | 56 (4.6) | 0.003 |
Patient decision | 82 (5.3) | 74 (6.1) | 0.196 |
Lost to follow-up | 64 (4.1) | 59 (4.9) | 0.203 |
Lack of efficacy | 50 (3.2) | 119 (9.9) | < 0.0001 |
Protocol violation | 36 (2.3) | 22 (1.8) | 0.523 |
Physician decision | 9 (0.6) | 9 (0.7) | 0.500 |
Sponsor decision | 2 (0.1) | 3 (0.2) | 0.419 |
Death | 1 (< 0.1) | 1 (< 0.1) | 0.822 |
Other | 1 (< 0.1) | 1 (< 0.1) | 0.822 |
N, total number of patients; n, number of affected patients.