Comparison · NCT04036253-sae
Eprex/Erypo vs Hemax PFS: 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. Eprex/Erypo vs Hemax PFS: serious adverse events. Trial comparisons, record NCT04036253-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04036253-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 | 0.2 | 0.0807 | 0.416 | wilson | |
| Risk in group 2 | 0.13 | 0.0454 | 0.321 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0696 | -0.156 | 0.302 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.53 | 0.389 | 6.04 | log | |
| Odds ratio, group 1 over group 2 | 1.67 | 0.325 | 8.55 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Eprex/Erypo than on Hemax PFS | 14.4 | 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 | Eprex/Erypo | Receive EPREX/ ERYPO® subcutaneously with an initial dose of 29 IU/ kg twice a week (2000 IU twice a week for 70 kg of weight), to be titrated according to the scheme that is summarized below.~There will be a follow - up of patients with visits to the site every two weeks during the first 12 weeks of dose titration that will be followed by 12 additional weeks of dose maintenance with visits every 4 weeks.~Erythropoietin alfa: Prefilled syringes of erythropoietin | 4 | 20 | EG000 |
| Group 2 | Hemax PFS | receive HEMAX® PFS subcutaneously with an initial dose of 29 IU/ kg twice a week (2000 IU twice a week for 70 kg of weight), to be titrated according to the scheme that is summarized below.~There will be a follow - up of patients with visits to the site every two weeks during the first 12 weeks of dose titration that will be followed by 12 additional weeks of dose maintenance with visits every 4 weeks.~Erythropoietin alfa: Prefilled syringes of erythropoietin | 3 | 23 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- After 12 and 24 weeks of treatment
Source ClinicalTrials.gov
Trial
- Title
- Study of HEMAX PFS Versus EPREX/ ERYPO® in Predialysis Chronic Kidney Disease
- NCT number
- NCT04036253
- Phases
- PHASE3
- Conditions
- Anemia of Chronic Kidney Disease
- Interventions
- Erythropoietin alfa
- Lead sponsor
- Bio Sidus SA
- Results first posted
- 2025-03-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04036253?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/NCT04036253-sae