Patient withdrawals* from the double-blind study and the longterm study.
| Reason for Withdrawal | Patients Without Postwithdrawal | |||||
|---|---|---|---|---|---|---|
| Studies | Treatment Group | Total, n (%) | Adverse Events, n (%) | Lack of Efficacy, n (%) | Other, n (%) | Efficacy Data, n (%) |
| WL-1001-05-01 (double-blind) | Civamide cream 0.075% | 55 (16) | 25 (7) | 4 (1) | 26 (8) | 3 (1) |
| Civamide cream 0.01% (control) | 29 (8) | 7a (2) | 3 (1) | 19 (5) | 4 (1) | |
| WL-1001-05-04 (longterm) | Civamide cream 0.075% | 67 (19) | 29b (8) | 7 (2) | 31 (9) | 22 (6) |
↵* Withdrawals are all patients who were enrolled but did not complete the planned course of treatment (includes patients who discontinued treatment or changed to a different treatment prematurely and/or were lost to followup).
↵a Includes a patient who was listed on the CRF as lost to followup but on the form for serious adverse events (SAE) as withdrawn due to the SAE.
↵b Includes a patient who died of lung cancer during the study. CRF: case report form.