Comparison · NCT01849497-sae
Evolocumab PFS vs Evolocumab AI/Pen: 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. Evolocumab PFS vs Evolocumab AI/Pen: serious adverse events. Trial comparisons, record NCT01849497-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01849497-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 | 0.04 | 0.0137 | 0.111 | wilson | |
| Risk in group 2 | 0.027 | 0.00744 | 0.0933 | wilson | |
| Risk difference, group 1 minus group 2 | 0.013 | -0.0583 | 0.0867 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.48 | 0.255 | 8.6 | log | |
| Odds ratio, group 1 over group 2 | 1.5 | 0.243 | 9.25 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Evolocumab PFS than on Evolocumab AI/Pen | 77.1 | 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 | Evolocumab PFS | Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS). | 3 | 75 | EG000 |
| Group 2 | Evolocumab AI/Pen | Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen). | 2 | 74 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first dose of study drug until 28 days after last study drug administration (up to 8 weeks)
Source ClinicalTrials.gov
Trial
- Title
- Study to Assess In-home Use of Evolocumab (AMG 145) Using a Prefilled Syringe or a Prefilled Autoinjector/Pen
- NCT number
- NCT01849497
- Phases
- PHASE3
- Conditions
- Primary Hypercholesterolemia, Mixed Dyslipidemia
- Interventions
- Evolocumab Pre-filled Syringe, Evolocumab AI/pen
- Lead sponsor
- Amgen
- Results first posted
- 2015-10-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01849497?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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