Table 5 Primary and secondary objectives
Efficacy outcomes | |
|---|---|
Primary efficacy outcome | Percentage of unfavourable outcomes by 24 months following the end of treatment |
Secondary efficacy outcomes | |
-Percentage of unfavourable outcomes by 18 months post randomization | |
-Percentage of recurrences by 24 months following the end of treatment. This is based on those individuals who have achieved cure at the end of the treatment | |
-Time to recurrence, defined from the date of treatment cure to the date of relapse | |
-Percentage of patients with sputum culture conversion at 8 weeks | |
-Percentage of patients with sputum smear negativity at 8 weeks | |
-Percentage of patients cured by the end of treatment | |
-Time to a composite (unsatisfactory) endpoint of treatment failure or relapse | |
Safety outcomes | |
Primary safety outcome | Percentage of adverse events |
Secondary safety outcome | The distribution of type and grading of adverse (based on DMID tables) |