Observed and predicted relapse rates in arms of three phase 3 trials of fluoroquinolone-containing regimens.

Evaluable subjects are those who at end-of-treatment have not met other unsatisfactory endpoints. Observed relapse rates are from per-protocol analyses, calculated as the number of subjects meeting the primary definition of recurrence in each trial (REMox: “relapse” + “retreated”; OFLOTUB: unfavorable outcomes at 18 months; RIFAQUIN: “culture confirmed” + “other”) divided by the number of evaluable subjects. Relapse was predicted using a model developed without data from the 3 trials in question, whose variables included total treatment duration and month 2 culture status using solid media [5]. E = ethambutol; G = gatifloxacin; H = isoniazid; M = moxifloxacin; P = rifapentine; R = rifampin; Z = pyrazinamide. Leading numbers in regimens indicate duration in months. Drugs were administered 7 days per week except as indicated by subscripts.Observed and predicted relapse rates in arms of three phase 3 trials of fluoroquinolone-containing regimens.