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Table 5 Primary and secondary objectives

From: A pivotal registration phase III, multicenter, randomized tuberculosis controlled trial: design issues and lessons learnt from the Gatifloxacin for TB (OFLOTUB) project

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)