Comparison · NCT00345839-sae
Cinacalcet 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
Cite this record
ConductScience Library. Cinacalcet vs Placebo: serious adverse events. Trial comparisons, record NCT00345839-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00345839-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 | 0.69 | 0.669 | 0.711 | wilson | |
| Risk in group 2 | 0.703 | 0.682 | 0.723 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0121 | -0.0411 | 0.0169 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.983 | 0.943 | 1.02 | log | |
| Odds ratio, group 1 over group 2 | 0.944 | 0.823 | 1.08 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Cinacalcet than on Placebo | 82.3 | 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 | Cinacalcet | Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments. | 1,338 | 1,938 | EG001 |
| Group 2 | Placebo | 1,351 | 1,923 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Average 24 months
Source ClinicalTrials.gov
Trial
- Title
- E.V.O.L.V.E. Trial™: EValuation Of Cinacalcet Hydrochloride (HCl) Therapy to Lower CardioVascular Events
- NCT number
- NCT00345839
- Phases
- PHASE3
- Conditions
- Secondary Hyperparathyroidism, Chronic Kidney Disease
- Interventions
- Cinacalcet, Placebo
- Lead sponsor
- Amgen
- Results first posted
- 2014-01-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00345839?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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