This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Safety and Efficacy Trial of Delamanid for 6 Months in Participants With Multidrug-resistant Tuberculosis (NCT01424670), a randomized phase 3 study. The primary outcome is Time To Sputum Culture Conversion (SCC) During 6-Month Intensive Period Using The Mycobacteria Growth Indicator Tube (MGIT) System.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01424670 |
| Phase | Phase 3 |
| Condition | Multidrug-resistant Tuberculosis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 511 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
The trial concerned participants with pulmonary, sputum culture-positive multidrug-resistant tuberculosis. The primary analysis population was the modified intent-to-treat group: randomized participants with a positive MTB sputum culture using MGIT and resistance to both isoniazid and rifampicin in specimens collected on Day -1 or Day 1, or both. The primary-endpoint arm counts were 226 for Delamanid + OBR and 101 for Placebo + OBR.
Intervention
Participants assigned to Delamanid + OBR received delamanid orally with OBR during the 6-month intensive period. The described regimen was 100 mg BID for 2 months, followed by 200 mg QD for 4 months.
Comparator
The control group received placebo orally with OBR during the same period. The described placebo schedule was BID for 2 months, followed by QD for 4 months. OBR is not expanded in the registry record.
Primary question
The primary question was whether time to sputum culture conversion differed between the groups during the 6-month intensive period, using the MGIT system. The registry reports median times and a modified Peto-Peto test. The reported medians were 51 days for Delamanid + OBR and 57 days for Placebo + OBR. These values describe the posted endpoint results; they do not, by themselves, establish a causal treatment effect or its clinical importance.
3. Trial Design
This was a phase 3, randomized, triple-masked, parallel-group, placebo-controlled trial sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. The registry lists 511 participants enrolled, a start date of 2011-09-02, primary completion on 2016-07-04, and a completed status. The official title describes a multicenter trial. The registry record does not report the details of the randomization procedure or the identities of the parties covered by triple masking.
Participants were assigned to Delamanid + OBR or Placebo + OBR. During the 6-month intensive period, the delamanid regimen was 100 mg orally BID for 2 months, then 200 mg orally QD for 4 months. The comparator followed a matching placebo schedule. The arm descriptions begin to refer to a period after the intensive period, but details of that later period are not reported in the registry record. OBR is not expanded in the registry record, so its components cannot be specified from this information.
The primary endpoint analysis used a modified intent-to-treat population rather than every enrolled participant: it included randomized participants meeting the stated MGIT culture and resistance criteria. The primary endpoint counts were 226 in the delamanid group and 101 in the placebo group. Safety counts used different denominators, 341 and 170, respectively. These populations and counts should not be treated as interchangeable. The registry record does not report the reason that the endpoint population differed from the safety population, or a complete account of participant flow.
The stated study purpose was to evaluate delamanid in combination with other MDR TB medications during 6 months of treatment. The record does not report the protocol’s sample-size justification, a full statistical analysis plan, or detailed rules for handling all analysis populations.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: 511 participants were randomized to receive investigational medicinal product (IMP) and an optimized background treatment regimen (OBR) for 6 months, followed by OBR treatment alone for 12-18 months. The trial also included a post-treatment follow-up period of 6-12 months. Participants who stopped taking IMP and/or OBR could remain in the study.
6-Month Intensive Period (182 Days)
| Stage | Delamanid + OBR | Placebo + OBR |
|---|---|---|
| STARTED | 341 | 170 |
| Received at Least 1 Dose of Study Drug | 341 | 170 |
| COMPLETED | 322 | 156 |
| NOT COMPLETED | 19 | 14 |
Reasons for not completing this period:
| Reason | Delamanid + OBR | Placebo + OBR |
|---|---|---|
| Adverse Event | 2 | 2 |
| Lost to Follow-up | 0 | 1 |
| Met Protocol Withdrawal Criteria | 2 | 1 |
| Physician Decision | 2 | 3 |
| Withdrawal by Subject | 13 | 7 |
Continuation Period
| Stage | Delamanid + OBR | Placebo + OBR |
|---|---|---|
| STARTED | 322 | 156 |
| COMPLETED | 288 | 142 |
| NOT COMPLETED | 34 | 14 |
Reasons for not completing this period:
| Reason | Delamanid + OBR | Placebo + OBR |
|---|---|---|
| Adverse Event | 13 | 5 |
| Lost to Follow-up | 2 | 0 |
| Met Protocol Withdrawal Criteria | 1 | 1 |
| Physician Decision | 5 | 4 |
| Withdrawal by Subject | 13 | 4 |
Analysis population for the primary outcome, as defined in the registry: The modified intent-to-treat (MITT) sample comprised all randomized participants who had a positive sputum culture for MTB in MGIT and were resistant to both isoniazid and rifampicin from the sputum samples collected on either Day -1 or Day 1, or both.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: The Intent-to-treat Sample comprised all participants who were randomized to receive either delamanid + OBR or placebo + OBR in this study.
| Characteristic | Unit | Delamanid + OBR | Placebo + OBR | Total |
|---|---|---|---|---|
| Participants analysed | 341 | 170 | 511 | |
| Age, Continuous | years | 34.3 (SD 12.1) | 34.4 (SD 12.2) | 34.3 (SD 12.1) |
| Sex: Female, Male: Female | Participants | 98 | 45 | 143 |
| Sex: Female, Male: Male | Participants | 243 | 125 | 368 |
6. Primary Endpoint
The registry lists the primary outcome as Time To Sputum Culture Conversion (SCC) During 6-Month Intensive Period Using The Mycobacteria Growth Indicator Tube (MGIT) System, measured over Month 6.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | Days |
| Endpoint classification | Time-to-Event Analysis |
The primary endpoint was median time to sputum culture conversion during the 6-month intensive period, measured in days using the Mycobacteria Growth Indicator Tube system. Culture conversion required a sputum specimen negative for MTB growth, followed by at least one confirmatory negative culture at least 25 days later, without a confirmed positive result. A confirmed positive was defined using at least two observed positive results, excluding indeterminate, missing, or contaminated results.
Two specimens were collected at each visit, and an algorithm in the statistical analysis plan selected a single representative result. Time to conversion ran from the first dose of investigational product to the first of two consecutive negative representative time points at least 25 days apart. The reported endpoint was the median time through Month 6.
Time to culture conversion is useful because it describes how long it took participants in the analysis population to meet a specified microbiological endpoint. A median gives the time by which half of the relevant observed time distribution has accrued, subject to the analysis method and follow-up. It is not the same as the proportion converted at a fixed visit, nor does it describe longer-term treatment success or relapse. The registry reports arm-specific medians and confidence intervals, with a modified Peto-Peto test for the comparison. It does not report a between-group median difference or its confidence interval.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary results give a median time to sputum culture conversion of 51 days for Delamanid + OBR, with a 95% confidence interval from 43 to 57 days, and 57 days for Placebo + OBR, with a 95% confidence interval from 56 to 64 days. The registry reports a modified Peto-Peto test and a p-value above 0.05. The numerical ordering of the medians is descriptive; it is not, on its own, evidence that the groups differed reliably.
The confidence intervals describe uncertainty around each arm’s median under the endpoint analysis. They are not confidence intervals for the difference between the groups. Because the registry does not report an estimated between-group median contrast with its confidence interval, the size and precision of that contrast cannot be read directly from these arm-specific intervals. The reported test supplies a comparison, but its result should be read alongside the endpoint definition, analysis population, and limits of the available statistical reporting.
The modified intent-to-treat population was restricted to randomized participants with a positive MGIT culture and resistance to both isoniazid and rifampicin in specimens collected on Day -1 or Day 1, or both. Therefore, the primary result describes this defined group, not automatically every enrolled participant. The primary endpoint counts were 226 and 101; the safety population counts were 341 and 170. This difference in denominators matters when comparing efficacy and safety summaries.
These data concern time to a culture-based endpoint during the intensive period. They do not, by themselves, answer whether participants had sustained culture conversion, achieved treatment success, avoided relapse, or had a particular final outcome. Those questions appear among the secondary outcomes, but the registry record does not include detailed results for most of them in the information summarized for this analysis.
Statistical evidence should not be reduced to whether a p-value crosses a threshold. A p-value describes how compatible the observed test result is with a specified null model, under the assumptions of the test; it is not the probability that the null hypothesis is true, nor a measure of clinical importance. The primary test result does not establish equivalence or absence of a difference. The registry record does not report an equivalence or noninferiority framework for this primary comparison.
9. Statistical Methods Explained
What does the median time describe?
The median time is a summary of the distribution of times to the endpoint. It is not an arithmetic average and does not show how every participant’s time was distributed. In this trial, the endpoint depended on two consecutive negative representative MGIT time points with the specified spacing and confirmation rules. The summary therefore describes time to that operational definition of conversion, rather than time to a broader clinical outcome.
Time-to-event methods are generally used when the outcome is a duration and some participants may not have an observed event within the analysis period. Such methods can account for incomplete follow-up through censoring, subject to assumptions about censoring and the analysis. The registry names a modified Peto-Peto test for the primary comparison, but does not report its detailed implementation, censoring rules, or the number of participants censored. Those details are not reported in the registry record.
What do the confidence intervals mean?
In general, a confidence interval expresses uncertainty in an estimate using a method with a stated coverage level. The posted 95% confidence intervals apply to the arm-specific medians. They should not be reinterpreted as an interval for the difference between medians. The registry does not give a confidence interval for that between-group contrast. The intervals also do not capture every possible source of uncertainty, such as limitations in the endpoint definition or the analysis assumptions.
How should the primary test be read?
The registry reports a modified Peto-Peto test for the primary comparison. In general, a test of this kind assesses evidence about differences between time-to-event distributions, rather than simply comparing the two median values. Its p-value is conditional on the null model and the test’s assumptions. It is not a probability that one treatment is superior, and it does not quantify the size or clinical importance of a difference. The registry does not report a hazard ratio for the primary endpoint, and no hazard ratio should be inferred from the median times.
What do the secondary recalculations represent?
For the time-averaged AUC of change from baseline in time to detection through Month 6, the posted arm means were 21.9 days for Delamanid + OBR and 23.3 days for Placebo + OBR. A simple unadjusted recalculation from these summaries gives a mean difference of -1.4 days, with a 95% confidence interval from -3.562 to 0.762 and an unadjusted p-value of 0.204. This is a comparison based on posted summary statistics, not the sponsor’s adjusted analysis.
The sponsor reports an ANCOVA comparison of final values for that endpoint: a mean difference of -0.3, a 95% confidence interval from -1.9 to 1.3, and a p-value of 0.699. The registry does not present these as the same estimand or analysis: the sponsor’s result is ANCOVA of final values, while the recalculation uses the displayed arm means for the time-averaged AUC. The unadjusted recalculation should therefore not replace the sponsor’s analysis.
Why do dispersion and analysis choices matter?
In general, a mean and standard deviation describe a continuous outcome differently from a median and confidence interval for a time-to-event outcome. The mean is sensitive to the distribution of values and extreme observations; the median is less sensitive to extremes but does not describe the full distribution. An analysis that adjusts for other variables may differ from a simple comparison of arm summaries. The registry does not report the covariates used in the ANCOVA, so their role cannot be evaluated from this record.
General statistical principle: over-dispersion occurs when variation is greater than a model assumes. If ignored, standard errors and confidence intervals can be too optimistic. The registry does not identify an over-dispersion issue for the primary endpoint, so this is a general consideration rather than a claim about this trial.
What do the planning illustrations mean?
The posted planning illustration is based on the observed effect for the time-averaged AUC endpoint, with equal allocation, a two-sided significance level of 0.05, and a normal approximation. For planning at 100% of the observed effect, it gives 691 participants per arm for 80% power and 925 participants per arm for 90% power. For planning at 75% of the observed effect, the corresponding figures are 1,229 and 1,644 participants per arm. For planning at 50% of the observed effect, they are 2,764 and 3,699 participants per arm. These are planning illustrations, not observed power and not the trial’s own sample-size justification. The protocol’s sample-size assumptions are not reported in the registry record.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| Modified Peto-Peto test | not reported | 0.056 |
For the primary endpoint, the registry reports arm-specific medians and confidence intervals, plus a modified Peto-Peto comparison. The reported p-value is above 0.05. It does not report a sponsor-estimated between-group median difference or its confidence interval. Consequently, the arm medians can be described, but the precision of a direct median contrast is not available in the registry record.
For the secondary time-averaged AUC outcome, the sponsor’s reported analysis is an ANCOVA of final values, with a mean difference of -0.3 and a 95% confidence interval from -1.9 to 1.3. Its reported p-value is 0.699. The unadjusted recalculation uses the posted means for the time-averaged AUC and gives a different estimate and test result. These are not identical analyses: one is an adjusted ANCOVA of final values, while the other is a simple comparison of arm-level summary statistics. They should not be treated as competing estimates of exactly the same analysis.
The registry record does not report the ANCOVA covariates or enough detail to reproduce the sponsor’s analysis. For a result based on a sponsor-reported analysis, that analysis is the relevant reported result; a summary-statistic recalculation is supplementary and should not override it.
11. Multiplicity, Missing Data and Analysis Populations
The registry lists 8 outcome measures and 14 analyses. It does not report whether the analyses were organized into a hierarchy, whether any adjustment was made for multiple testing, or which secondary comparisons were intended to be confirmatory. This information is important because the chance of at least one apparently notable result can increase when many hypotheses are tested. General statistical principle: multiplicity procedures control or describe that risk by accounting for the number and structure of comparisons. The appropriate approach depends on the trial’s prespecified objectives and analysis plan, which are not reported in the registry record.
The record names a statistical analysis plan algorithm for selecting a representative MGIT result from two specimens at each visit. It does not provide the full analysis plan, including missing-data rules, censoring details, sensitivity analyses, or the handling of participants without an evaluable endpoint. Those methods are not reported in the registry record and should not be inferred from the endpoint description.
The primary analysis population is explicitly defined as modified intent-to-treat: randomized participants with a positive MGIT sputum culture and resistance to both isoniazid and rifampicin in the specified Day -1 or Day 1 specimens. The primary endpoint counts were 226 and 101. Safety counts were 341 and 170. Since these populations have different denominators, the primary efficacy summary and adverse-event summary do not describe exactly the same analysis set. A complete participant-flow account and reasons for the different counts are not reported in the registry record.
These limitations affect what can be concluded from the posted statistics. The reported primary result applies to the defined modified intent-to-treat group and the specified culture-conversion endpoint. It cannot automatically be generalized to all enrolled participants or to outcomes that were not reported. Missing-data handling and multiplicity procedures are not technical footnotes: they influence how uncertainty and the strength of secondary evidence should be understood.
12. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Delamanid + OBR | 89 | 341 | 26.1% |
| Placebo + OBR | 47 | 170 | 27.6% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Delamanid + OBR | 18 of 341 |
| Placebo + OBR | 8 of 170 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Delamanid + OBR | 335 of 341 |
| Placebo + OBR | 165 of 170 |
Most frequent serious adverse event terms
| Event term | Organ system | Delamanid + OBR | Placebo + OBR |
|---|---|---|---|
| Tuberculosis | Infections and infestations | 11 of 341 | 3 of 170 |
| Hypokalaemia | Metabolism and nutrition disorders | 9 of 341 | 3 of 170 |
| Deafness bilateral | Ear and labyrinth disorders | 4 of 341 | 4 of 170 |
| Acute kidney injury | Renal and urinary disorders | 3 of 341 | 5 of 170 |
| Electrocardiogram QT prolonged | Investigations | 6 of 341 | 1 of 170 |
| Hepatotoxicity | Hepatobiliary disorders | 3 of 341 | 2 of 170 |
| Pneumonia | Infections and infestations | 3 of 341 | 2 of 170 |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | 3 of 341 | 2 of 170 |
| Transaminases increased | Investigations | 1 of 341 | 3 of 170 |
| Hypomagnesaemia | Metabolism and nutrition disorders | 3 of 341 | 1 of 170 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Delamanid + OBR | Placebo + OBR |
|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | 116 of 341 | 65 of 170 |
| Nausea | Gastrointestinal disorders | 95 of 341 | 56 of 170 |
| Headache | Nervous system disorders | 104 of 341 | 39 of 170 |
| Insomnia | Psychiatric disorders | 87 of 341 | 46 of 170 |
| Vomiting | Gastrointestinal disorders | 92 of 341 | 39 of 170 |
| Nasopharyngitis | Infections and infestations | 71 of 341 | 43 of 170 |
| Tinnitus | Ear and labyrinth disorders | 71 of 341 | 36 of 170 |
| Gastritis | Gastrointestinal disorders | 76 of 341 | 27 of 170 |
| Diarrhoea | Gastrointestinal disorders | 62 of 341 | 33 of 170 |
| Hypokalaemia | Metabolism and nutrition disorders | 53 of 341 | 29 of 170 |
Serious events with the highest arm-level rate: tuberculosis (3.2%), acute kidney injury (2.9%), hypokalaemia (2.6%), deafness bilateral (2.4%), transaminases increased (1.8%).
The safety summaries use 341 participants at risk in the Delamanid + OBR group and 170 in the Placebo + OBR group. Serious adverse events affected 89 participants in the delamanid group and 47 in the placebo group. The registry also reports 18 deaths in the delamanid group and 8 in the placebo group. These counts are descriptive; they do not establish that a study treatment caused an event or death. The registry record does not provide the causal attribution details needed to make that judgment.
Among the listed serious adverse-event terms, the reported percentages include Tuberculosis at 3.2%, acute kidney injury at 2.9%, hypokalaemia at 2.6%, bilateral deafness at 2.4%, increased transaminases at 1.8%, and prolonged QT on electrocardiogram at 1.8%. These selected terms do not constitute a full account of all adverse events, their severity, timing, or relatedness. The registry record does not report those details in the information summarized for this analysis.
Counts should be interpreted with their denominators and the trial’s safety population in mind. They are not directly comparable to the primary efficacy counts, which come from a narrower modified intent-to-treat population.
13. What the Result Does, and Does Not, Mean
The primary result describes the observed time to a specifically defined MGIT sputum culture-conversion endpoint in the modified intent-to-treat population during the 6-month intensive period. The median was 51 days in the Delamanid + OBR group and 57 days in the Placebo + OBR group. The reported comparison was a modified Peto-Peto test, with a p-value above 0.05. This is evidence about the posted endpoint and analysis, not a complete account of treatment benefit or harm.
The result does not establish that the groups are equivalent. A result that does not cross a conventional significance threshold is not proof of no difference; it may reflect uncertainty, the observed data, or features of the design and analysis. The registry does not report an equivalence or noninferiority objective for this comparison. Nor does the result establish that a difference is clinically important: the record does not provide a clinical-importance threshold for the median time endpoint.
The arm-specific confidence intervals quantify uncertainty in the medians, not the between-group difference. Because no confidence interval for a median contrast is reported, readers should not infer the precision of that contrast by treating the two intervals as if they were a direct comparison. The test result and the descriptive medians answer related but distinct statistical questions.
The endpoint also has a limited scope. It is a microbiological outcome within the intensive period, with a confirmation rule requiring consecutive negative results. It does not, on its own, establish sustained conversion, final treatment success, relapse status, or longer-term health outcomes. Those outcomes are among the listed secondary measures, but most of their detailed results are not reported in the registry record.
Finally, the primary result applies to the defined analysis population. It should not be generalized automatically to all 511 enrolled participants, or to populations and treatment settings not described in the record. Statistical interpretation is strongest when it stays close to the endpoint, population, and analysis actually reported.
14. Why This Trial Matters Statistically
This trial illustrates why the endpoint definition is central to interpreting a clinical result. “Culture conversion” is not simply one negative specimen in this record: it depends on MGIT testing, representative results selected by an algorithm, a confirmatory negative result, and a minimum interval between negative time points. Those rules define the event whose timing is summarized. Different operational definitions could answer different questions, so the posted median should be read in the context of the stated criteria.
It also shows why analysis populations need to be distinguished. The study enrolled 511 participants, while the primary endpoint was analyzed in the stated modified intent-to-treat population and safety was summarized in groups with different counts. Clear population definitions help readers understand which participants contribute to each result and prevent inappropriate comparisons across denominators.
Another statistical lesson is that a pair of medians is not the same as an estimated treatment contrast with its uncertainty. The registry reports medians, their arm-specific confidence intervals, and a time-to-event test. It does not report a confidence interval for the difference between medians. A careful reading keeps those quantities separate rather than attempting to construct an unreported contrast from the displayed summaries.
Finally, the record illustrates the importance of complete reporting. Multiplicity procedures, missing-data methods, detailed primary test implementation, and the protocol’s sample-size justification are not reported in the registry record. Their absence limits how fully readers can assess the confirmatory status and robustness of the findings. The statistical value of a trial record depends not only on its estimates, but also on transparent descriptions of how those estimates were obtained.
15. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The primary comparison is reported through arm-specific medians and confidence intervals plus a modified Peto-Peto test, but no between-group median estimate with a confidence interval is reported. This limits direct assessment of the magnitude and precision of the primary contrast. The registry also does not give detailed implementation information for the test, including censoring rules and numbers censored.
The modified intent-to-treat primary population is narrower than the enrolled population, and its arm counts differ from the safety counts. Although the primary population criteria are stated, participant flow and reasons for the population differences are not reported in the registry record. The results should therefore be understood as applying to the defined analysis populations rather than assumed to cover every enrolled participant equally.
The available secondary results do not cover all listed outcomes. Most detailed secondary findings, including the longer-term outcomes in the registry’s list, are not reported in the registry record. This restricts evaluation of whether the primary culture-conversion result aligns with sustained conversion, final treatment outcomes, or relapse. The limited information also prevents a full appraisal of the pattern across the trial’s outcome measures.
The registry does not report its multiplicity strategy, general missing-data approach, detailed covariates for the sponsor’s ANCOVA, or the trial’s own sample-size justification. In addition, details after the 6-month intensive period are not reported in the registry record. These are trial-specific reporting limitations, not evidence that a particular method was or was not used. The safety figures are counts and selected serious-event terms; they do not by themselves establish causation or provide a complete assessment of event timing and relatedness.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Safety and Efficacy Trial of Delamanid for 6 Months in Participants With Multidrug-resistant Tuberculosis — NCT01424670.
- Registry record last updated 2019-05-15; status last verified 2019-05.
- Results first posted 2019-05-15.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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19. Record Summary
NCT01424670 is a completed phase 3 randomized, triple-masked, parallel-group, placebo-controlled trial of Delamanid + OBR versus Placebo + OBR in multidrug-resistant tuberculosis. The registry lists 511 enrolled participants. The primary endpoint was median time to sputum culture conversion by MGIT during the 6-month intensive period, in a modified intent-to-treat population defined by culture and resistance criteria.
The reported medians were 51 days and 57 days, respectively, with a modified Peto-Peto comparison whose p-value was above 0.05. The record also lists secondary outcomes and safety findings, but detailed results are not available for most listed secondary outcomes. Important statistical details, including multiplicity procedures and general missing-data methods, are not reported in the registry record.