Comparison · NCT01813422-sae
Evolocumab 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. Evolocumab vs Placebo: serious adverse events. Trial comparisons, record NCT01813422-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01813422-sae
On this page
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 | 0.279 | 0.241 | 0.321 | wilson | |
| Risk in group 2 | 0.293 | 0.255 | 0.335 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0145 | -0.0712 | 0.0424 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.951 | 0.779 | 1.16 | log | |
| Odds ratio, group 1 over group 2 | 0.932 | 0.705 | 1.23 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Evolocumab than on Placebo | 69.1 | 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 | Participants received 420 mg evolocumab administered by subcutaneous injection once a month for 76 weeks. | 135 | 484 | EG001 |
| Group 2 | Placebo | Participants received placebo to evolocumab administered by subcutaneous injection once a month for 76 weeks. | 142 | 484 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first dose of study drug until week 80
Source ClinicalTrials.gov
Trial
- Title
- GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound
- NCT number
- NCT01813422
- Phases
- PHASE3
- Conditions
- Hypercholesterolemia
- Interventions
- Evolocumab, Placebo
- Lead sponsor
- Amgen
- Results first posted
- 2018-01-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01813422?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT01813422-sae