Comparison · NCT02265952-sae
Main Study Period: REGN1500 250 mg SC/15 mg/kg IV/450 mg SC vs OLE Period: REGN1500 300 mg SC/20 mg/kg IV: 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. Main Study Period: REGN1500 250 mg SC/15 mg/kg IV/450 mg SC vs OLE Period: REGN1500 300 mg SC/20 mg/kg IV: serious adverse events. Trial comparisons, record NCT02265952-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02265952-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 | 0.111 | 0.0199 | 0.435 | wilson | |
| Risk in group 2 | 0.25 | 0.0715 | 0.591 | wilson | |
| Risk difference, group 1 minus group 2 | -0.139 | -0.492 | 0.231 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.444 | 0.0491 | 4.02 | log | |
| Odds ratio, group 1 over group 2 | 0.375 | 0.0272 | 5.17 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Main Study Period: REGN1500 250 mg SC/15 mg/kg IV/450 mg SC than on OLE Period: REGN1500 300 mg SC/20 mg/kg IV | 7.2 | 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 | Main Study Period: REGN1500 250 mg SC/15 mg/kg IV/450 mg SC | Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 \[Day 183\]) after the last dose of study drug in the main study period. | 1 | 9 | EG000 |
| Group 2 | OLE Period: REGN1500 300 mg SC/20 mg/kg IV | Participants received REGN1500 a SC injection of 300 mg at Week 26 (Day 183), 27(Day 190), 28 (Day 197) and 29 (Day 204) followed by IV injection of 20 mg/kg at Week 38 (Day 267) and every 12 weeks starting at Week 58 (Day 407) through Week 178 (Day 1247) in open-label extension period. Participants were to be followed for a period of 24 weeks (through Week 214 \[Day 1499\]) after the last dose of study drug in the OLE treatment period. | 2 | 8 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (up to Day 183 in Main Study Period, and up to Day 1499 in Open-Label Extension Period,regardless of seriousness or relationship to investigational product.
Source ClinicalTrials.gov
Trial
- Title
- Study of REGN1500 in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
- NCT number
- NCT02265952
- Phases
- PHASE2
- Conditions
- Homozygous Familial Hypercholesterolemia
- Interventions
- REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
- Lead sponsor
- Regeneron Pharmaceuticals
- Results first posted
- 2019-12-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02265952?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
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