Table 3.
Patient disposition, number (%) of patients
| CLIN/RA GEL | CLINDAMYCIN GEL | TOTAL | |
|---|---|---|---|
| Safety evaluable patients | 1008 | 1002 | 2010 |
| ITT patients | 1008 | 1002 | 2010 |
| PP patients | 727 (72.1) | 718 (71.7) | 1445 (71.9) |
| NUMBER OF PATIENTS ATTENDING VISIT-N (%) | |||
| Screening (Visit 1) | 1008 (100) | 1002 (100) | 2010 (100) |
| Baseline (Week 0, Visit 2) | 1008 (100) | 1002 (100) | 2010 (100) |
| Week 2 (Visit 3) | 886 (87.9) | 866 (86.4) | 1752 (87.2) |
| Week 4 (Visit 4) | 835 (82.8) | 823 (82.1) | 1658 (82.5) |
| Week 8 (Visit 5) | 743 (73.7) | 732 (73.1) | 1475 (73.4) |
| Week 12 (Final Visit) | 790 (78.4) | 781 (77.9) | 1571 (78.2) |
| Patients completing the study | 859 (85.2) | 838 (83.6) | 1697 (84.4) |
| Patients withdrawn from the study | 149 (14.8) | 164 (16.4) | 313 (15.6) |
| REASON PATIENT DID NOT COMPLETE TREATMENT PHASE | |||
| Patient request | 17 (1.7) | 28 (2.8) | 45 (2.2) |
| Adverse event | 6 (0.6) | 2 (0.2) | 8 (0.4) |
| Protocol violation | 1 (0.1) | 0 (0.0) | 1 (0.05) |
| Withdrawal of consent | 27 (2.7) | 20 (2.0) | 47 (2.3) |
| Lost to follow up | 92 (9.1) | 108 (10.8) | 210 (10.0) |
| Noncompliance | 1 (0.1) | 3 (0.3) | 4 (0.2) |
| Other | 5 (0.5) | 3 (0.3) | 8 (0.4) |
- ITT
- intent-to-treat
- PP
- per protocol