2. Sensitivity analysis: moxifloxacin‐based 4‐month versus standard 6‐month ATT regimens.
Primary outcome: relapse | ||||||
Trial ID | Gillespie 2014 | Jawahar 2013 | Jindani 2014 | |||
Regimens | 4 months | 6 months | 4 months | 6 months | 4 months | 6 months |
aModified‐ITT analysis (primary analysis) | 110/1119 (9.8%) |
13/555 (2.3%) |
11/108 (10.1%) |
10/155 (6.5%) |
27/165 (16.4%) |
6/163 (3.7%) |
aPer‐protocol analysis | 110/1038 (10.6%) |
12/510 (2.4%) |
11/107 (10.1%) |
10/152 (6.6%) |
26/165 (15.8%) |
5/163 (3.1%) |
bSensitivity analysis imputing missing data | 126/1184 (10.7%) |
14/577 (2.4%) |
11/114 (9.7%) |
10/159 (6.3%) |
36/225 (16.0%) |
71/232 (2.6%%) |
Abbreviations: ATT: anti‐tuberculosis treatment; ITT: intention‐to‐treat.
aAs reported in trial reports. bIncludes in the denominators for each trial arm all randomized participants minus those excluded post randomization due to ineligibility (not confirmed TB, or drug resistant), those who died, and those who experienced treatment failure. The difference in this denominator and the denominator in per‐protocol analyses are missing data. Relapse rates for missing people were imputed from rates in the per‐protocol analysis for each trial arm.