Comparison · NCT01656434-sae
NOMAC-E2 vs NETA-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
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ConductScience Library. NOMAC-E2 vs NETA-EE: serious adverse events. Trial comparisons, record NCT01656434-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01656434-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 | 0.00811 | 0.00526 | 0.0125 | wilson | |
| Risk in group 2 | 0.0132 | 0.00673 | 0.0259 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00513 | -0.0181 | 0.00273 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.613 | 0.271 | 1.38 | log | |
| Odds ratio, group 1 over group 2 | 0.609 | 0.267 | 1.39 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on NOMAC-E2 than on NETA-EE | 195 | 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 | NOMAC-E2 | Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28. | 20 | 2,465 | EG000 |
| Group 2 | NETA-EE | Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28. | 8 | 604 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 54 weeks
Source ClinicalTrials.gov
Trial
- Title
- Study of the Contraceptive Efficacy and Safety of a NOMAC-E2 Combined Oral Contraceptive (COC)(P06448)
- NCT number
- NCT01656434
- Phases
- PHASE3
- Conditions
- Contraception
- Interventions
- NOMAC-E2, NETA-EE, Placebo, ethinylestradiol (EE), ferrous fumarate
- Lead sponsor
- Organon and Co
- Results first posted
- 2015-03-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01656434?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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