Comparison · NCT03263091-7529551f
DB Component: Roxadustat vs DB Component: Placebo: DB Component: Number of Participants Who Achieved TI ≥56 Consecutive Days Since First Dose in 52 Weeks of Treatment
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 TI ≥56 Consecutive Days Since First Dose in 52 Weeks of Treatment. Trial comparisons, record NCT03263091-7529551f. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03263091-7529551f
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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 | 0.55 | 0.441 | 0.654 | wilson | |
| Risk in group 2 | 0.404 | 0.286 | 0.533 | wilson | |
| Risk difference, group 1 minus group 2 | 0.146 | -0.0227 | 0.303 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.36 | 0.939 | 1.98 | log | |
| Odds ratio, group 1 over group 2 | 1.81 | 0.908 | 3.6 | log | |
| Number needed to treat, for one more participant with the outcome on DB Component: Roxadustat than on DB Component: Placebo | 6.83 | 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. | 44 | 80 | OG000 |
| Group 2 | DB Component: Placebo | Participants received placebo matched to roxadustat for 52 weeks. | 23 | 57 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- DB Component: Number of Participants Who Achieved TI ≥56 Consecutive Days Since First Dose in 52 Weeks of Treatment
- Description
RBC TI was defined as the absence of any IV RBC transfusion (packed cell or whole blood) during any consecutive 56 days during the treatment period. Data presented is for number of participants with RBC TI ≥56 consecutive days since first dose in the 52 weeks of treatment.
- Time frame
- 52 weeks
- 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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