Table 3 Definition of the favorable and unfavorable outcomes in ORIENT study

Favorable outcome

The outcome will be classified as favorable if not classified as unfavorable or not assessable and meets any one of the following criteria

1) The sputum culture is negative for M. tuberculosis at the end of follow-up period

2) The sputum can be contaminated or no longer be produced at the end of follow-up period, without evidence of active pulmonary tuberculosis after a stable sputum culture conversion^a has been achieved

Unfavorable outcome

The outcome will be classified as unfavorable if:

1) Sputum culture is positive for M. tuberculosis for two consecutive times after treatment; And the second strain is confirmed indistinguishable from the original isolate by the whole genome sequencing. If the whole genome sequencing result is not available, it defaults to the same strain

2) The sputum culture at the last visit of follow-up is positive for M. tuberculosis

3) Participants die during treatment (excluding force majeure factors such as homicide, traffic accidents or natural disasters); death associated with tuberculosis during follow-up (after completion of study treatment)

4) Withdrawal from the trial or loss to follow-up during treatment (except pregnancy, accident, etc.)

5) Participants stop the initial treatment, and restart different tuberculosis treatments

6) Restart tuberculosis treatment after the end of expected treatment

7) The treatment course exceeds the expected treatment length by more than 2 weeks regardless of any reason

8) The treatment regimen is changed (including dosage or frequency of administration) except for pregnancy, exogenous reinfection, and rechallenge

Not assessable

The outcome will be classified as not assessable if not classified as unfavorable and meets any one of the following criteria:

1) Loss to follow-up (after completion of study treatment) with the last sputum culture being negative;

2) Sputum cannot be produced or is contaminated at the end of follow-up period, but stable culture conversion has not been achieved before and the last sputum culture is negative;

3) Alteration of treatment due to pregnancy;

4) Death unrelated to tuberculosis during follow-up (after completion of study treatment);

5) Death due to force majeure such as homicide, car accident or natural disaster during treatment;

6) Extension or change of tuberculosis treatment after the whole genome sequencing confirms exogenous reinfection