Comparison · NCT02867813-839b50fc
Evolocumab Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study vs Placebo Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study: Number of Participants Who Experienced an Adverse Event
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. Evolocumab Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study vs Placebo Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study: Number of Participants Who Experienced an Adverse Event. Trial comparisons, record NCT02867813-839b50fc. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02867813-839b50fc
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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 | 0.834 | 0.819 | 0.848 | wilson | |
| Risk in group 2 | 0.847 | 0.832 | 0.86 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0128 | -0.0331 | 0.00742 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.985 | 0.961 | 1.01 | log | |
| Odds ratio, group 1 over group 2 | 0.909 | 0.781 | 1.06 | log | |
Number needed to treat, for one fewer participant with the outcome on Evolocumab Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study than on Placebo Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study | 78 | 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 | Evolocumab Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study | Participants in the parent study who received evolocumab subcutaneous injections either Q2W or QM, and received evolocumab 140 mg Q2W or 420 mg QM in the open label extension according to the participant's preference. | 2,084 | 2,499 | OG001 |
| Group 2 | Placebo Once Every 2 Weeks (Q2W) or Once a Month (QM) in Parent Study | Participants in the parent study who received placebo subcutaneous injections either Q2W or QM, and received evolocumab 140 mg every 2 weeks Q2W or 420 mg monthly QM in the open label extension, according to the participant's preference. | 2,144 | 2,532 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants Who Experienced an Adverse Event
- Description
All adverse event summaries for the primary analysis of the primary endpoint (OLE study period only) included all treatment-emergent events reported on the Event electronic case report form (eCRF), including CEC positively reviewed events and disease-related events.
- Time frame
- Up to 5 years
- Population
- OLE Safety Analysis Set which included all participants who received at least 1 dose of open-label evolocumab in the OLE study.
Source ClinicalTrials.gov
Trial
- Title
- Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension
- NCT number
- NCT02867813
- Phases
- PHASE3
- Conditions
- Dyslipidemia
- Interventions
- Evolocumab
- Lead sponsor
- Amgen
- Results first posted
- 2023-02-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02867813?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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