Table 3 Populations set for analysis
Population | Description |
|---|---|
Intent-to-treat (ITT) | All randomized participants |
Safety analysis set | All randomized participants who consume at least 1 dose of the study intervention |
Modified ITT | Subset of the ITT with proper diagnosis, including all randomized participants with a positive MTB culture result at screening or randomization; excludes participants who provided isolates prior to randomization that were subsequently found to harbor RIF-susceptible MTB or participants who provided isolates prior to randomization that were subsequently found to be resistant to drugs in the regimens (including low-level INH resistance), as revealed by phenotypic DST results |
Efficacy analysis set | All enrolled participants with confirmed pulmonary MDR-TB and a positive MTB culture at screening or baseline who were not withdrawn from the study because they harbored MTB with baseline resistance to prescribed drugs and consumed at least 1 dose of study treatment |