Table 2.
Clinical cure rates at test of cure in efficacy populationsa
| Patient population | % of patients cured at indicated oritavancin dose (no. of patients with response/total no. of patients)b |
Estimated difference in % of patients cured at indicated oritavancin doses (90% CI)c |
|||
|---|---|---|---|---|---|
| 200 mg (n = 98)d | 1,200 mg (n = 99) | 800 mg (n = 103) | 1,200 and 200 mg | 800 and 200 mg | |
| Intent to treat | 72.4 (63/87) | 81.8 (72/88) | 78.2 (68/87) | 8.7 (−1.7, 17.8) | 5.1 (−5.8, 14.6) |
| Clinically evaluable | 72.4 (55/76) | 81.5 (66/81) | 77.5 (55/71) | 8.6 (−2.5, 18.2) | 5.2 (−6.8, 15.4) |
| Wound | 65.4 (17/26) | 66.7 (18/27) | 72.0 (18/25) | 1.3 (−20.1, 22.7) | 6.6 (−14.7, 27.9) |
| Major abscess | 92.3 (24/26) | 90.0 (27/30) | 87.5 (21/24) | −2.3 (−14.8, 10.1) | −4.8 (−18.9, 9.2) |
| Cellulitis | 58.3 (14/24) | 87.5 (21/24) | 72.7 (16/22) | 29.2 (9.2, 49.1)e | 14.4 (−8.4, 37.2) |
| Microbiological intent to treat | 68.8 (44/64) | 80.3 (49/61) | 80.6 (50/62) | 10.1 (−2.7, 20.9) | 11.1 (−1.5, 21.7) |
| Microbiologically evaluable | 69.1 (38/55) | 79.3 (46/58) | 81.3 (39/48) | 8.5 (−5.2, 20.0) | 11.0 (−2.9, 22.6) |
“Cure” includes cure and improvement outcomes.
Excludes missing or intermediate patients.
Difference in response rate between patients as determined by using the Mantel-Haenszel method, stratified by disease.
Two patients in the intent-to-treat population were unblinded prior to completion of the study. These two patients are therefore not included in any efficacy analyses. Both patients were in the 200-mg-daily-dosing group and were assessed as cured at TOC. Including these patients in the efficacy analyses does not change the statistical significance among the treatment groups.
After data analysis was complete, it was discovered that one patient randomized to the 1,200-mg-single-dose group actually received 200 mg/day for 6 days. A sensitivity analysis was performed by switching the patient from the single-dose group to the daily-dose group, and the statistical significance remained unchanged in the cellulitis disease category.