Comparison · NCT00090753-sae
Methoxy Polyethylene Glycol-Epoetin Beta vs Comparator ESA: 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. Methoxy Polyethylene Glycol-Epoetin Beta vs Comparator ESA: serious adverse events. Trial comparisons, record NCT00090753-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00090753-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 | 0.667 | 0.633 | 0.7 | wilson | |
| Risk in group 2 | 0.658 | 0.615 | 0.699 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00878 | -0.0449 | 0.0633 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.01 | 0.934 | 1.1 | log | |
| Odds ratio, group 1 over group 2 | 1.04 | 0.816 | 1.33 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Methoxy Polyethylene Glycol-Epoetin Beta than on Comparator ESA | 114 | 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 | Methoxy Polyethylene Glycol-Epoetin Beta | Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL. | 499 | 748 | EG000 |
| Group 2 | Comparator ESA | Patients received the same comparator ESA \[epoetin alfa, epoetin beta, or darbepoetin alfa\] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta. | 316 | 480 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months)
Source ClinicalTrials.gov
Trial
- Title
- A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia
- NCT number
- NCT00090753
- Phases
- PHASE3
- Conditions
- Anemia
- Interventions
- Methoxy Polyethylene Glycol-Epoetin Beta, Epoetin alfa, Epoetin beta, Darbepoetin alfa
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2012-01-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00090753?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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