Comparison · NCT01652872-sae
Hb-Based Titration Group vs Fixed Dose Group: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Hb-Based Titration Group vs Fixed Dose Group: serious adverse events. Trial comparisons, record NCT01652872-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01652872-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 | 0.504 | 0.454 | 0.554 | wilson | |
| Risk in group 2 | 0.464 | 0.414 | 0.515 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0398 | -0.0314 | 0.11 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.09 | 0.937 | 1.26 | log | |
| Odds ratio, group 1 over group 2 | 1.17 | 0.881 | 1.56 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Hb-Based Titration Group than on Fixed Dose Group | 25.1 | 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 | Hb-Based Titration Group | Participants received darbepoetin alfa as a SC injection, Q4W for up to 96 weeks. The dose of darbepoetin alfa was titrated based on the Hb concentration on the date of the visit, the corresponding Hb ROR, and the previously assigned dose. Doses were reduced if Hb exceeded 10.5 g/dL or Hb ROR exceeded 1.0 g/dL/4W. When darbepoetin alfa therapy was withheld per the dosing algorithm, placebo was administered. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg. | 190 | 377 | EG000 |
| Group 2 | Fixed Dose Group | Participants received darbepoetin alfa as a SC injection Q4W at the same dose as assigned at the time of randomization for the duration of the 96-week treatment period. There was 1 exception to the fixed dose strategy: if the Hb was \> 12.0 g/dL, darbepoetin alfa therapy was withheld and placebo administered. Once the Hb fell to \< 10.0 g/dL, darbepoetin alfa therapy resumed at the same dose. The starting dose of darbepoetin alfa was 0.45 mcg/kg and the protocol specified doses ranged from 10 to 300 mcg. | 175 | 377 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Treatment Emergent Adverse Events were collected from randomization on study day 1 until 4 weeks after final dose of investigational product (up to 101 weeks).
Source ClinicalTrials.gov
Trial
- Title
- Strategies Using Darbepoetin Alfa to Avoid Transfusions in Chronic Kidney Disease
- NCT number
- NCT01652872
- Phases
- PHASE3
- Conditions
- Anemia in Chronic Kidney Disease Patients Not on Dialysis
- Interventions
- Darbepoetin alfa, Placebo
- Lead sponsor
- Amgen
- Results first posted
- 2018-11-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01652872?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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GET https://conductscience.org/api/comparisons/v1/NCT01652872-sae