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Table 1 Mapping from primary outcome to FoR event

From: Investigation of the efficacy of the short regimen for rifampicin-resistant TB from the STREAM trial

Likelihood classification as FoR event

Primary outcome classification, with further details where relevant for mapping

Total participants in MITT population

Highly unlikely

Favorable

292

Unlikely

Treatment change because of baseline DST results

3

Treatment change because of investigator decisiona

2

Died during treatment or follow-up, culture converted when last seen, death not related to TB

13

Treatment changed following proven reinfection with exogenous strain of M. tuberculosis (using whole genome sequencing or other appropriate method)

8

Treatment change after adverse event

7

Lost to follow-up after 76 weeks, culture converted when last seen

6

Died within first 2 weeks of treatment, never achieved culture conversion

1

Lost to follow-up before 76 weeks (but after 40 weeks), culture converted when last seen

4

Possible

Lost to follow-up before 76 weeks, patient withdrew consentb

8

Treatment changed after patient withdrew consent for study medicationc

4

Died at 8 weeks having not yet achieved culture conversion, death not related to TB

2

Treatment changed after loss to follow-up or poor adherence, with no positive bacteriology to suggest treatment failure

2

Probable

Died during treatment, probably related to TB

3

Both positive and negative cultures within week 132 analysis window when last seend

2

Death 27 weeks after randomization, culture positive when last seen

1

Relapse after treatment, signs and symptoms with limited bacteriology

1

Reversion on treatment, signs and symptoms with limited bacteriology

1

Definite

Treatment changed following bacteriological reversion on treatment

14

Treatment changed following bacteriological relapse after treatment

5

Died following bacteriological reversion on treatment

2

Lost to follow-up before 76 weeks following bacteriological reversion on treatment

1

Treatment changed after failure to achieve culture conversion

1

  1. aTreatment change so that participant could receive same treatment as young child (n = 1) or following a positive pregnancy test result (n = 1)
  2. bReason for withdrawal of consent was due to adverse event (n = 4), or reason unknown (n = 4). All but one withdrew consent during the intensive phase of treatment; the participant that was an exception was initially lost to follow-up from the intensive phase and subsequently returned and then withdrew consent
  3. cReason for withdrawal of consent was due to adverse event (n = 2), or reason unknown (n = 2)
  4. dResults of m TB strain genotyping showed same strain as baseline (n = 1) and no comparison possible (n = 1)
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BMC Medicine

ISSN: 1741-7015

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