Comparison · NCT00160199-sae
Prometrium 300 mg/Day vs Prometrium 400 mg/Day: 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. Prometrium 300 mg/Day vs Prometrium 400 mg/Day: serious adverse events. Trial comparisons, record NCT00160199-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00160199-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 | 0.0177 | 0.00487 | 0.0622 | wilson | |
| Risk in group 2 | 0.00935 | 0.00165 | 0.051 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00835 | -0.0353 | 0.0536 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.89 | 0.174 | 20.6 | log | |
| Odds ratio, group 1 over group 2 | 1.91 | 0.171 | 21.4 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Prometrium 300 mg/Day than on Prometrium 400 mg/Day | 120 | 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 | Prometrium 300 mg/Day | 2 | 113 | EG000 | |
| Group 2 | Prometrium 400 mg/Day | 1 | 107 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- The adverse events presented were collected from start of drug treatment to the end of the treatment period.
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy of PROMETRIUM® Capsules in Induction of Secretory Conversion
- NCT number
- NCT00160199
- Phases
- PHASE4
- Conditions
- Secondary Amenorrhea
- Interventions
- PROMETRIUM® 300 mg, PROMETRIUM® 400 mg
- Lead sponsor
- Solvay Pharmaceuticals
- Results first posted
- 2010-06-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00160199?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/NCT00160199-sae