Occurrence of adverse events (AEs) during the 1-year safety extension phase (full analysis set). (AEs are shown for all women who participated in the safety extension phase and according to the regimens received in the 1-year comparative phase)
| Regimen received in comparative phase† | ||||
|---|---|---|---|---|
| Adverse event [n (%)] | All women (n=727) | FlexibleMIB (n=453) | Conventional 28-day (n=155) | Fixed extended (n=119) |
| Any AE | 409 (56.3) | 244 (53.9) | 104 (67.1) | 61 (51.3) |
| Most frequent AEs* | ||||
| Diarrhoea | 39 (5.4) | 25 (5.5) | 7 (4.5) | 7 (5.9) |
| Headache | 53 (7.3) | 25 (5.5) | 20 (12.9) | 8 (6.7) |
| Nasopharyngitis | 81 (11.1) | 51 (11.3) | 19 (12.3) | 11 (9.2) |
| Discontinued due to AE | 9 (1.1) | 5 (1.0) | 4 (2.4) | 0 (0) |
| Any SAEs | 29 (2.7) | 19 (3.0) | 3 (1.4) | 7 (3.3) |
Data shown as mean (SD).
↵* AEs (shown in alphabetical order) are those that occurred in >5% of all women who participated in the 1-year safety extension phase.
↵† During the safety extension phase, all women received ethinylestradiol 20 µg/drospirenone 3 mg in the flexibleMIB regimen with the exception of 28 women participating in the bone mineral density analysis. Such women continued to receive either the conventional 28-day or fixed extended regimens.
AE, adverse event; MIB, management of intracyclic (breakthrough) bleeding; SAE, serious adverse event.