Table 3 Study outcome definitions

Death:

Death of a patient from all causes.

Treatment failure in standard of care arm:

Conventional MDR-TB regimen

The presence of a positive mycobacterial culture in MGIT liquid media in each of two separate specimens taken at least four weeks apart (+/− 2 weeks) from week 28 until week 108

Shorter MDR-TB regimen

The presence of a positive mycobacterial culture in MGIT liquid media in each of two separate specimens taken at least four weeks apart from week 16 (+/− 2 weeks) or later

Treatment failure in investigational arms:

The presence of a positive culture in MGIT liquid media in each of two separate specimens taken at least four weeks apart from week 16 (+/− 2 weeks) or later.

Lost-to-Follow-up:

A patient who has missed his/her appointment after completing treatment and cannot be traced until the end of the expected follow-up period (108 weeks or at time of censure).

Treatment discontinuation:

A decision by an investigator to discontinue treatment:

1) either due to the need to significantly modify the trial regimen for whatever reason,

2) or due to the patient missing some or all drugs regularly

3) or due to the patient missing all drugs for more than 2 consecutive weeks

Still on treatment:

A subject who is still taking treatment for M/XDR-TB 108 weeks after starting but hasn’t been declared as treatment failure.

Culture conversion:

At least two consecutive negative sputum cultures taken 4 weeks apart (+/− 2 weeks). The date of the first negative culture will be considered the conversion date.

Recurrence :

A subject who has completed treatment without being declared a failure and who has subsequently been diagnosed and require MDR-TB treatment (for whom there is evidence that the recurrence is due to an MDR or XDR TB strain)

Re-infection:

A subject who has completed treatment without being declared a failure and who has subsequently been diagnosed and require MDR-TB treatment but for whom there is evidence that the recurrence is due to a different strain to the baseline specimen. If the strain is a DS strain the patient is subsequently non-assessable.

Relapse:

A subject who has completed treatment without being declared a failure and who has subsequently been diagnosed and require MDR-TB treatment and for whom there is evidence that the recurrence is due to the same strain recorded in the baseline specimen.

Unfavourable outcome:

A composite outcome comprising death, treatment failure, treatment discontinuation, loss to follow up, still on treatment at 108 weeks and recurrence.