The independent Advisory Council came to the following conclusions:

1) no major differences among the cohorts were found in the rates for overall SAEs, organ-system specific SAEs, overall mortality and outcome-specific mortality, overall cancer and organ-system specific cancer.

2) Overall, for all outcomes studied an increased risk for users of a DRSP-containing OC compared to users of other OCs (including LNG-containing OCs) was not identified.

These results suggest that the risks of adverse cardiovascular outcomes in users of a DRSP-containing OC are similar to the risks associated with the use of LNG-containing OCs or other OCs.