Comparison · NCT03263091-c830cdb2
DB Component: Roxadustat vs DB Component: Placebo: DB Component: Number of Participants Who Achieved TI ≥20 Consecutive Weeks During the Study
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. DB Component: Roxadustat vs DB Component: Placebo: DB Component: Number of Participants Who Achieved TI ≥20 Consecutive Weeks During the Study. Trial comparisons, record NCT03263091-c830cdb2. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03263091-c830cdb2
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.288 | 0.2 | 0.395 | wilson | |
| Risk in group 2 | 0.263 | 0.166 | 0.39 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0243 | -0.13 | 0.169 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.09 | 0.627 | 1.9 | log | |
| Odds ratio, group 1 over group 2 | 1.13 | 0.527 | 2.42 | log | |
| Number needed to treat, for one more participant with the outcome on DB Component: Roxadustat than on DB Component: Placebo | 41.1 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | DB Component: Roxadustat | Participants received roxadustat 2.5 mg/kg TIW for 52 weeks. | 23 | 80 | OG000 |
| Group 2 | DB Component: Placebo | Participants received placebo matched to roxadustat for 52 weeks. | 15 | 57 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- DB Component: Number of Participants Who Achieved TI ≥20 Consecutive Weeks During the Study
- Description
≥20 consecutive weeks TI was defined as the absence of any IV RBC transfusion (packed cell or whole blood) during any consecutive 140 days anytime during the study (up to 56 weeks). TI was estimated between the first dose date (Day 1) and the end of study (Week 56) or treatment discontinuation due to AE/SAE or death, whichever came earlier.
- Time frame
- Baseline up to Week 56
- Population
- FAS included all enrolled participants who received at least 1 dose of study medication, and at least 1 corresponding on-treatment Hb assessment.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Roxadustat for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome With Low Red Blood Cell Transfusion Burden
- NCT number
- NCT03263091
- Phases
- PHASE3
- Conditions
- Primary MDS (Very Low, Low or Intermediate IPSS-R With <5% Blasts), Anemia
- Interventions
- Roxadustat, Placebo
- Lead sponsor
- Kyntra Bio
- Results first posted
- 2024-08-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03263091?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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