Trial · NCT02589782
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Stage 1:Percentage of patients with culture conversion in liquid media at 8 weeks post randomisation. | 8 weeks post randomisation | |
| Primary | Stage 1: Percentage of patients who discontinue treatment for any reason or die | 8 weeks post randomisation | |
| Primary | Stage 2: Percentage of patients with an unfavourable outcome (failure, death, recurrence, loss to follow-up) | 72 weeks post-randomisation | |
| Secondary | Stage 1: Percentage of patients with grade 3 or higher QT prolongation | within 8 weeks post randomisation | |
| Secondary | Stage 1: Percentage of patients experiencing at least one Serious Adverse Event (SAE) | within 8 weeks post randomisation | |
| Secondary | Stage 1:Percentage of patients experiencing at least one new grade 3 or higher Adverse Event | within 8 weeks post randomisation | |
| Secondary | Stage 2: Percentage of patients with culture conversion | 12 weeks post randomisation | |
| Secondary | Stage 2: Percentage of patients with an unfavourable outcome (i.e. failure, treatment discontinuation, death, loss to follow up) | 24 weeks post randomisation | |
| Secondary | Stage 2: Percentage of patients with an unfavourable outcome (i.e. failure, treatment discontinuation, death, loss to follow up, still on treatment at censure and recurrence) | 108 weeks post randomisation | |
| Secondary | Stage 2: Median time to culture conversion | 108 weeks | |
| Secondary | Stage 2: Percentage of patients with an SAE or new grade 3 or higher AE | 72 weeks post randomisation | |
| Secondary | Stage 2: Percentage of patients with an SAE or new grade 3 or higher AE | 108 weeks post randomisation | |
| Secondary | Stage 2: Percentage of patients with an SAE or new grade 3 or higher AE at the end of treatment | 24 weeks in investigational arms and 108 weeks in SOC arm | The percentage of patients with an SAE or new grade 3 or higher AE at the end of treatment in the investigational arms (maximum of 24 weeks) and the SOC arm which varies in length (maximum 108 weeks). |
| Secondary | Stage 2: Mean single ΔQTcF | 24 weeks post randomisation | |
| Secondary | Stage 2: Percentage of patients experiencing recurrence | week 48 in investigational arms | |
| Secondary | Stage 2: Plasma drug concentrations | In relation to dose intake and start of treatment over a 72 week period | |
| Secondary | Stage 2: TB drug hair levels | In relation to dose intake and start of treatment over a 72 week period |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02589782/registered