Comparison · NCT01788046-sae
Etelcalcetide vs Placebo: 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. Etelcalcetide vs Placebo: serious adverse events. Trial comparisons, record NCT01788046-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01788046-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 | 0.246 | 0.197 | 0.303 | wilson | |
| Risk in group 2 | 0.274 | 0.223 | 0.331 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0281 | -0.104 | 0.048 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.897 | 0.669 | 1.2 | log | |
| Odds ratio, group 1 over group 2 | 0.864 | 0.582 | 1.28 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Etelcalcetide than on Placebo | 35.6 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Etelcalcetide | Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks. | 62 | 252 | EG001 |
| Group 2 | Placebo | Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. | 71 | 259 | EG000 |
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
- Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
- NCT number
- NCT01788046
- Phases
- PHASE3
- Conditions
- Hyperparathyroidism, Secondary
- Interventions
- Etelcalcetide, Placebo
- Lead sponsor
- Amgen
- Results first posted
- 2017-03-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01788046?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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