Retrospective Cohort Study on the Risk of Venous Thromboembolism with the use of combined oral contraceptives containing Chlormadinone Acetate/Ethinylestradiol and Levonorgestrel/Ethinylestradiol (RIVET-RCS)

ENCePP Seal

This study has been awarded the ENCePP seal

Conflicts of interest of investigators

Annex5_Declaration of interest _RivetCC_2016

Composition of steering group and observers

SMAC_RIVET-CC_2016-04-14

Signed code of conduct

2016-0039-DoC CoC-SDPP-12171

Signed code of conduct checklist

2016-0039-Checklist CoC-SDPP-12171

Signed checklist for study protocols

2016-0039-Checklist Protocol-SDPP-12171

Data sources

• Data sources (types):
  Other
• Data sources (types), other:
  This study is designed as a retrospective cohort study. ZEG Berlin conducted several large prospective cohort studies on the risk of VTE associated with the use of hormonal contraceptives. Four of these studies included a substantial number of women using CMA/EE or LNG/EE-containing COCs: LASS/EURAS-OC, INAS-OC, INAS-FOCUS, INAS-SCORE.

Use of a Common Data Model (CDM)

• CDM mapping:
  No

Data quality specifications

• Check conformance:
  Unknown
• Check completeness:
  Unknown
• Check stability:
  Unknown
• Check logical consistency:
  Unknown

Data characterisation

• Data characterisation conducted:
  No