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Table 4 Re-classification decisions concerning the major efficacy outcome

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

  Situations Classification Comments/Date of event
Treatment phase
 1 Two cultures + vea at the end of the treatment phase Unfavorable Last scheduled day of the treatment
 2 One culture + ve + second culture not done or contaminated Unfavorable Last scheduled day of the treatment
Death
 3 Death: no information suggesting it was not related to TB Unfavorable Date of death occurrence
 4 Death: documented evidence that it was not related to TB (for example, car accident) Unfavorable Date of death occurrence
Withdrawals (other than death and before the end of treatment)
 5 SAEb for which treatment is stopped Unfavorable Date when TB treatment stopped
 6 Pregnancy (so treatment is stopped) Not assessable Date when TB treatment stopped
 7 Patient withdrawal of consent Unfavorable Date of withdrawal
Follow-up phase c
 1 Culture -ve + data available for all visits or data available for last follow-up visit Favorable Date of last culture -ve
 2 Two cultures + ve (at least 1 day apart) during follow-up and organism id is Mtb Unfavorable Date of the first sampling with culture + ve
 3 One culture + ve and organism id is Mtb + second culture not done or contaminated Unfavorable Date of the sampling with the culture + ve
 4 Death and one culture + ve based on most recent culture result and organism id is Mtb Unfavorable Date of the sampling with culture + ve
 5 Death and culture -ve based on most recent culture result (or contaminated) Not assessable or Unfavorable Endpoint committee reviews available data
Withdrawals (other than death):
 6 Patient withdrawal of consent and one culture + ve based on most recent culture result Unfavorable Date of the sampling with culture + ve
 7 Patient withdrawal of consent and culture -ve based on most recent culture result (or contaminated) Non-assessable for the period after being withdrawn Favorable till the date of last culture -ve/Non-assessable the day after the last visit
 8 Lost during follow-up/moved away from area and one culture + ve based on most recent culture result Unfavorable Date of the sampling with culture + ve
 9 Lost during follow-up/moved away from area and culture -ve based on most recent culture result (or contaminated) Non-assessable for the period after being withdrawn Favorable till the date of last culture -ve
Non-assessable the day after the last visit
  1. aPositive.
  2. bSerious adverse event.
  3. cDefined among those patients classified as cured at the end of the treatment phase. Cure is defined as two consecutive negative cultures.