Comparison · NCT02616146-ae504219
ENG-E2 125 μg/300 μg vs LNG-EE 150 μg/30 μg: Number of Participants Who Experienced an Adverse Event (AE)
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. ENG-E2 125 μg/300 μg vs LNG-EE 150 μg/30 μg: Number of Participants Who Experienced an Adverse Event (AE). Trial comparisons, record NCT02616146-ae504219. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02616146-ae504219
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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 | 0.352 | 0.329 | 0.377 | wilson | |
| Risk in group 2 | 0.285 | 0.246 | 0.326 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0678 | 0.0201 | 0.113 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.24 | 1.06 | 1.45 | log | |
| Odds ratio, group 1 over group 2 | 1.37 | 1.1 | 1.71 | log | |
| Number needed to treat, for one more participant with the outcome on ENG-E2 125 μg/300 μg than on LNG-EE 150 μg/30 μg | 14.7 | 8.84 | 49.7 | from the risk difference interval |
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 | ENG-E2 125 μg/300 μg | Participants were to receive up to 13 cycles of ENG-E2 125 μg/300 μg. Each cycle was to consist of 21 days of vaginal ring use followed by 7 vaginal ring-free days. | 530 | 1,504 | OG000 |
| Group 2 | LNG-EE 150 μg/30 μg | Participants were to receive up to 13 cycles of LNG-EE 150 μg/30 μg. Each cycle was to consist of one tablet per day for 21 days, followed a 7-day tablet-free interval. | 140 | 492 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants Who Experienced an Adverse Event (AE)
- Description
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment.
- Time frame
- Up to 1 year
- Population
- This primary endpoint was based on all randomized participants in whom at least one vaginal ring was inserted or one comparator tablet was ingested.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Etonogestrel + 17β-Estradiol Vaginal Ring and Levonorgestrel-Ethinyl Estradiol Combined Oral Contraceptive in Adult Women at Risk for Pregnancy (MK-8342B-062)
- NCT number
- NCT02616146
- Phases
- PHASE3
- Conditions
- Contraception
- Interventions
- ENG-E2 125 μg/300 μg vaginal ring, LNG-EE 150 μg/30 μg COC
- Lead sponsor
- Organon and Co
- Results first posted
- 2019-01-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02616146?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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