PRO-E2 Study: Venous and Arterial Thromboembolism Risk in Oral Contraceptive Users
by Suzanne Reed
Available on 1 platform
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Description
Suzanne Reed's PRO-E2 study is a prospective controlled cohort study assessing the risk of venous and arterial thromboembolism in users of a monophasic oral contraceptive containing nomegestrol acetate and 17β-oestradiol (NOMAC-E2) compared to levonorgestrel-containing combined oral contraceptive (COCLNG) users. The study enrolled 101,498 women across 12 countries in Australia, Europe, and Latin America, with up to 2 years of follow-up and 144,901 woman-years of observation. It calculated incidence rates and hazard ratios for thromboembolic events, with outcomes validated via treating physicians and independent blinded adjudication.
Use Cases
Compare thromboembolism incidence rates between contraceptive types based on the reported hazard ratios and confidence intervals.
Analyze the impact of confounders like age and BMI on thromboembolism risk based on the study's adjusted analyses.
Validate pharmacoepidemiological study designs based on the described non-inferiority, prospective observational, and active surveillance methodology.
Assess the safety profile of nomegestrol acetate/estradiol contraceptives based on the reported outcomes for deep venous thrombosis and pulmonary embolism.
Strengths
Large cohort of 101,498 women, providing substantial statistical power for the analysis.
Prospective, multi-country design across 12 nations in Australia, Europe, and Latin America, enhancing generalizability.
Detailed follow-up of up to 2 years, accumulating 144,901 woman-years of observation.
Rigorous outcome validation via treating physicians and independent blinded adjudication of events.
Limitations
Column-level documentation is absent; field semantics must be inferred after download.
Row count is unknown, which may limit suitability assessment for specific analytical tasks.
Last update date is unknown; freshness unverified.
Provenance
Source
Suzanne Reed (author), sourced from paperswithcode.
Collection Method
Prospective, observational active surveillance study with a non-inferiority design. Women were recruited as new users and followed directly, with self-reported outcomes validated via physicians.
Time Range
Follow-up period of up to 2 years for participants.
Geography
12 countries across Australia, Europe, and Latin America.
License is listed as Open Access (green), but specific terms are not detailed.