Table 4 Definition of primary treatment outcome {12}

Proportion of participants with a favourable outcome at week 73

The outcome is not classified as unfavourable, and one of the following is true:

1. The last two culture results are negative. These two cultures must be taken from sputum samples collected on separate visits, the latest between weeks 65 and 73.

2. The last culture result (from a sputum sample collected between weeks 65 and 73) is negative, and either there is no other post-baseline culture result or the penultimate culture result is positive due to laboratory cross contamination, and bacteriological, radiological and clinical evolution is favourable.

3. There is no culture result from a sputum sample collected between weeks 65 and 73 or the result of that culture is positive due to laboratory cross contamination, and the most recent culture result is negative, and bacteriological, radiological, and clinical evolution is favourable.

Any of the following:

1. Replacement or addition of one or more investigational drugs in an experimental arm (failure).

2. Replacement or addition of two or more investigational drugs in the control arm (failure).

3. Initiation of a new MDR-TB treatment regimen after the end of the allocated study regimen and before week 73 (relapse).

4. Death from any cause.

5. At least one of the last two cultures, the latest being from a sputum sample collected between weeks 65 and 73, is positive in the absence of evidence of laboratory cross contamination (failure/relapse).

6. The last culture result (from a sputum sample collected between weeks 65 and 73) is negative; AND there is no other post-baseline culture result or the penultimate culture is positive due to laboratory cross contamination; and bacteriological, radiological, or clinical evolution is unfavourable (failure/relapse).

7. There is no culture result from a sputum sample collected between weeks 65 and 73 or it is positive due to laboratory cross contamination.

AND the most recent culture is negative; and bacteriological, radiological or clinical evolution is unfavourable (failure/relapse); or the most recent culture result is positive in the absence of laboratory cross contamination.

8. The outcome is not assessable because there is no culture result from a sputum sample collected between weeks 65 and 73 or it is positive due to laboratory cross contamination.

AND

- There is no other post-baseline culture result or the most recent culture is positive due to laboratory cross contamination.

- The most recent culture is negative and bacteriological, radiological, and clinical evolution is not assessable.

9. Previously classified as unfavourable in the present study (except for participants whose outcome at 39 weeks was unfavourable because it was unassessable).