Comparison · NCT02278341-sae
Roxadustat vs ESA (Erythropoiesis-Stimulating Agent): serious adverse events
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. Roxadustat vs ESA (Erythropoiesis-Stimulating Agent): serious adverse events. Trial comparisons, record NCT02278341-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02278341-sae
On this page
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 | 0.507 | 0.459 | 0.555 | wilson | |
| Risk in group 2 | 0.45 | 0.403 | 0.498 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0572 | -0.0105 | 0.124 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.13 | 0.978 | 1.3 | log | |
| Odds ratio, group 1 over group 2 | 1.26 | 0.958 | 1.65 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Roxadustat than on ESA (Erythropoiesis-Stimulating Agent) | 17.5 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Roxadustat | Participants received roxadustat three times a week (TIW) for at least 52 weeks up to a maximum of 104 weeks. Participants received initial dose of roxadustat in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met. | 210 | 414 | EG000 |
| Group 2 | ESA (Erythropoiesis-Stimulating Agent) | Participants received epoetin alfa once weekly, twice weekly or TIW and darbepoetin alfa once a week or once every other week. Participants were treated for at least 52 weeks up to a maximum of 104 weeks. Treatment dosage was adjusted according to the pre-specified rule of keeping the participant's Hb levels between 10.0 to 12.0 g/dL. Participants were not allowed to switch from epoetin alfa to darbepoetin alfa or vice versa. | 189 | 420 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first dose of study drug up to End of Study (EOS) (Up to week 108)
Source ClinicalTrials.gov
Trial
- Title
- Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable Dialysis
- NCT number
- NCT02278341
- Phases
- PHASE3
- Conditions
- Anemia, End Stage Renal Disease (ESRD)
- Interventions
- Roxadustat, Epoetin alfa, Darbepoetin alfa, Iron
- Lead sponsor
- Astellas Pharma Europe B.V.
- Results first posted
- 2020-08-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02278341?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT02278341-sae