Table 4 Re-classification decisions concerning the major efficacy outcome
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and culture -ve based on most recent culture result (or contaminated) | Non-assessable for the period after being withdrawn | Favorable till the date of last culture -ve/Non-assessable the day after the last visit |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area and culture -ve based on most recent culture result (or contaminated) | Non-assessable for the period after being withdrawn | Favorable till the date of last culture -ve Non-assessable the day after the last visit |