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Comparison · NCT01656434-961e214d

NOMAC-E2 vs NETA-EE: Number of Participants Who Experience at Least One Venous or Arterial Thrombotic/Thromboembolic Event

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: Number of Participants Who Experience at Least One Venous or Arterial Thrombotic/Thromboembolic Event. Trial comparisons, record NCT01656434-961e214d. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01656434-961e214d

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 1000.00156wilson
Risk in group 20.001660.0002920.00932wilson
Risk difference, group 1 minus group 2-0.00166-0.009320.000413newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to treat, for one fewer participant with the outcome on NOMAC-E2 than on NETA-EE604from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1NOMAC-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.
02,465OG000
Group 2NETA-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.
1604OG001

Outcome

Type
SECONDARY
Title
Number of Participants Who Experience at Least One Venous or Arterial Thrombotic/Thromboembolic Event
Description
Time frame
Up to 54 weeks
Population
All Subjects as Treated Population, which consisted of all randomized participants who took at least one dose of trial medication. One treated participant in the NOMAC-E2 treatment group had incomplete data and was not included in the Safety Analyses.

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

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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