Table 3.
Reasons for study drug discontinuation.
Reason Drug Discontinuation | Fluconazole (N = 33) | Placebo (N = 39) | All Subjects (N = 72) |
---|---|---|---|
Lost to Follow-up (%) | 10 (30) | 7 (18) | 17 (24) |
Voluntary Withdrawal by Subject (%) | |||
Unable to Return for Follow-up | 0 | 4 (10) | 4 (6) |
Moved Away for Work | 2 (6) | 0 | 2 (3) |
Decrease in Sleep | 0 | 2 (5) | 2 (3) |
Worried about Long-Term Side Effects | 0 | 2 (5) | 2 (3) |
Withdrawal by Investigator (%) | |||
Unblinded for Treatment for Coccidioidomycosis | 0 | 2 (5) | 2 (3) |
Patient-Reported Syncopal Event | 2 (6) | 0 | 2 (3) |
Health-Related Event (%) | |||
Atrial Fibrillation | 0 | 2 (5) | 3 (4) |
Pruritis | 1 (3) | 0 | 1 (1) |
Deemed Ineligible after Enrollment (due QTc> 450 ms) (%) | 1 (3) | 0 | 1 (1) |