Table 2 Summary of reported outcomes, out of 31 clinical trials

Start with negative culture

2

Defined by one negative culture: “culture negative” at specified time

2

12

Culture(-) not having been retreated or had tx changed or extended

2

Defined by two negative cultures, with varying intervals between cultures

1

12

Defined by three negative cultures

2

2

Defined by all negative cultures in specified time period

1

Inability to produce sputum addressed, with various qualifications

10

No signs/symptoms and can’t produce sputum

2

No signs/symptoms and sputum is contaminated in 2 cultures with no evidence of TB

2

Incomplete culture results but clinical symptoms favorable

2

Relapse-free cure

2

Never convert to culture negative

2

1

Do not have negative status, inconsistent qualifications

6

Persistently positive after specified time

1

Culture positive, confirmed by second (+) sample ≥ 4hr after first (+) culture

2

Two or more (+) cultures at least 1 month apart after 2mos in study and still on tx

2

Culture positive at end

4

2

≥ 1 of last two cultures on separate occasions are (+)

1

Culture of ≥20 colonies

1

≥ 2 (+) cultures in last month, one of which is 20 colonies or more

2

2

5

2

29

2

3

13

Any cause

5

7

2

2

TB-related

11

14

Death from extra-pulmonary TB

1

Any non-TB-related death

1

1

4

3

Non-TB, except accident, violence, trauma

7

7

9

1

Non-TB, except suicide

6

6

3

Death from a different TB strain

1

Died with last culture negative

5

Did not reach endpoint, varying qualifications

13

No culture result at end of FU or last culture contaminated

2

Culture (+) when last seen

4

4

Any withdrawal of or loss to follow-up

2

4

2

2

2

7

Extension, with varying exceptions

11

2

Restart, with varying exceptions

11

Change treatment, with varying exceptions

10

2

Initiation of treatment for relapse in absence of culture confirmation

1

Change one drug, with varying exceptions

5

3

Change more than one drug

5

4

Discontinue treatment, with exceptions

10

9

Discontinue treatment, due to pregnancy

2

Incomplete, with varying qualifications

5

Off-protocol drugs

3

3

1