Comparison · NCT01896232-sae
Cinacalcet vs Etelcalcetide: 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. Cinacalcet vs Etelcalcetide: serious adverse events. Trial comparisons, record NCT01896232-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01896232-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 | 0.273 | 0.228 | 0.322 | wilson | |
| Risk in group 2 | 0.251 | 0.208 | 0.3 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0212 | -0.0449 | 0.0871 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.08 | 0.842 | 1.4 | log | |
| Odds ratio, group 1 over group 2 | 1.12 | 0.793 | 1.57 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Cinacalcet than on Etelcalcetide | 47.1 | 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 | Cinacalcet | Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL. | 93 | 341 | EG000 |
| Group 2 | Etelcalcetide | Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL. | 85 | 338 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From Day 1 until 30 days after the last dose; the treatment period was 26 weeks.
Source ClinicalTrials.gov
Trial
- Title
- Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet
- NCT number
- NCT01896232
- Phases
- PHASE3
- Conditions
- Secondary Hyperparathyroidism, Chronic Kidney Disease
- Interventions
- Etelcalcetide, Cinacalcet, Oral Placebo, Intravenous Placebo
- Lead sponsor
- Amgen
- Results first posted
- 2017-02-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01896232?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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