Comparison · NCT00773513-sae
Erythropoiesis Stimulating Agents vs Methoxy Polyethylene Glycol-Epoetin Beta: 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. Erythropoiesis Stimulating Agents vs Methoxy Polyethylene Glycol-Epoetin Beta: serious adverse events. Trial comparisons, record NCT00773513-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00773513-sae
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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 | 0.797 | 0.775 | 0.817 | wilson | |
| Risk in group 2 | 0.779 | 0.756 | 0.799 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0185 | -0.0117 | 0.0486 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.02 | 0.985 | 1.06 | log | |
| Odds ratio, group 1 over group 2 | 1.12 | 0.932 | 1.34 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Erythropoiesis Stimulating Agents than on Methoxy Polyethylene Glycol-Epoetin Beta | 54.2 | 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 | Erythropoiesis Stimulating Agents | Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta. | 1,123 | 1,409 | EG000 |
| Group 2 | Methoxy Polyethylene Glycol-Epoetin Beta | Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin \[Hb\] 10-12 grams per deciliter \[g/dL\]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly. | 1,097 | 1,409 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline up to approximately 8.5 years
Source ClinicalTrials.gov
Trial
- Title
A Study to Assess All-Cause Mortality and Cardiovascular Morbidity in Participants With Chronic Kidney Disease (CKD) on Dialysis and Those Not on Renal Replacement Therapy Receiving Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) or Reference Erythropoietin Stimulating Agents (ESAs)
- NCT number
- NCT00773513
- Phases
- PHASE4
- Conditions
- Chronic Renal Anemia
- Interventions
- Darbepoetin Alfa, Epoetin Alfa, Epoetin Beta, methoxy polyethylene glycol-epoetin beta
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2018-08-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00773513?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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