Comparison · NCT00745901-sae
NGM/25mcg EE vs DRSP/20mcg EE: 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. NGM/25mcg EE vs DRSP/20mcg EE: serious adverse events. Trial comparisons, record NCT00745901-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00745901-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 | 0.012 | 0.00329 | 0.0426 | wilson | |
| Risk in group 2 | 0.00599 | 0.00106 | 0.0331 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00599 | -0.0225 | 0.037 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2 | 0.183 | 21.8 | log | |
| Odds ratio, group 1 over group 2 | 2.01 | 0.181 | 22.4 | log | |
| Number needed to harm, for one more participant with a serious adverse event on NGM/25mcg EE than on DRSP/20mcg EE | 167 | 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 | NGM/25mcg EE | NGM=norgestimate; EE=ethinyl estradiol. Days 1-7: 180 mcg NGM/25 mcg EE; Days 8-14: 215 mcg NGM/25 mcg EE; Days 15-21: 250 mcg NGM/25 mcg EE; Days 22-28: inert ingredients | 2 | 167 | EG000 |
| Group 2 | DRSP/20mcg EE | DRSP=drospirenone; EE=ethinyl estradiol. Days 1-24: 3 mg DRSP/20 mcg EE; Days 25-28: inert ingredients | 1 | 167 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 35 days prior to the first day study drug was taken to study day 91 (or 7 days after last day of study drug)
Source ClinicalTrials.gov
Trial
- Title
- Study to Evaluate Cycle Control With Norgestimate/Ethinyl Estradiol and Drospirenone/Ethinyl Estradiol in Healthy Sexually Active Females
- NCT number
- NCT00745901
- Phases
- PHASE4
- Conditions
- Contraception
- Interventions
- Norgestimate/ethinyl estradiol; Drospirenone/ethinyl estradiol
- Lead sponsor
- Ortho-McNeil Janssen Scientific Affairs, LLC
- Results first posted
- 2010-05-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00745901?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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