Comparison · NCT01004029-sae
17P (Hydroxyprogesterone Caproate Injection) vs Vehicle: 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. 17P (Hydroxyprogesterone Caproate Injection) vs Vehicle: serious adverse events. Trial comparisons, record NCT01004029-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01004029-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 | 0.0301 | 0.0216 | 0.0418 | wilson | |
| Risk in group 2 | 0.0311 | 0.0198 | 0.0487 | wilson | |
| Risk difference, group 1 minus group 2 | -0.001 | -0.0205 | 0.0153 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.968 | 0.552 | 1.7 | log | |
| Odds ratio, group 1 over group 2 | 0.967 | 0.541 | 1.73 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on 17P (Hydroxyprogesterone Caproate Injection) than on Vehicle | 1,000 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: vehicle.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | 17P (Hydroxyprogesterone Caproate Injection) | HPC 250 mg/mL in oil~Hydroxyprogesterone Caproate Injection, 250mg/mL: 1 mL intramuscular injection every week until 36 weeks, 6 days of gestation or delivery, whichever occurs first. | 34 | 1,128 | EG001 |
| Group 2 | Vehicle | Castor Oil~Vehicle: Weekly intramuscular injections of 1 mL vehicle inert oil until 36 weeks, 6 days of gestation or delivery, whichever occurs first. | 18 | 578 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Randomized subjects were followed up to 35 ± 7 days after the last dose of study drug. Maternal and fetal deaths were reported until delivery if delivery occurred after 35 ± 7 days after last dose.
Source ClinicalTrials.gov
Trial
- Title
- Confirmatory Study of 17P vs Vehicle for Prevention of Preterm Birth in Women w/ Previous Spontaneous Preterm Delivery
- NCT number
- NCT01004029
- Phases
- PHASE3
- Conditions
- Preterm Birth
- Interventions
- Hydroxyprogesterone Caproate Injection (HPC), 250mg/mL, Vehicle
- Lead sponsor
- AMAG Pharmaceuticals, Inc.
- Results first posted
- 2021-01-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01004029?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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