Comparison · NCT03263091-e0763477
DB Component: Roxadustat vs DB Component: Placebo: DB Component: Number of Participants Who Achieved ≥50% Reduction From Baseline in Number of pRBC Transfusions Over 8 Weeks
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. DB Component: Roxadustat vs DB Component: Placebo: DB Component: Number of Participants Who Achieved ≥50% Reduction From Baseline in Number of pRBC Transfusions Over 8 Weeks. Trial comparisons, record NCT03263091-e0763477. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03263091-e0763477
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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 | 0.738 | 0.632 | 0.821 | wilson | |
| Risk in group 2 | 0.649 | 0.519 | 0.76 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0884 | -0.0648 | 0.243 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.14 | 0.901 | 1.43 | log | |
| Odds ratio, group 1 over group 2 | 1.52 | 0.726 | 3.18 | log | |
| Number needed to treat, for one more participant with the outcome on DB Component: Roxadustat than on DB Component: Placebo | 11.3 | 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. | 59 | 80 | OG000 |
| Group 2 | DB Component: Placebo | Participants received placebo matched to roxadustat for 52 weeks. | 37 | 57 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- DB Component: Number of Participants Who Achieved ≥50% Reduction From Baseline in Number of pRBC Transfusions Over 8 Weeks
- Description
Baseline number of transfusions (pRBC/8-weeks) = total number of packs of rRBCs within 16 weeks prior to first dose/2. A pRBC transfusion reduction responder was defined as a participant who achieved ≥50% reduction in number of pRBC transfusions over 8 weeks compared to their baseline for any 8 week period in the duration begining with the first dose date (Day 1) and ending with the end of study or treatment discontinuation due to adverse event (AE)/serious adverse event (SAE) or death, whichever came earlier.
- Time frame
- Baseline up to Week 8
- 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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