Adverse events occurring in the comparative phase of the study with ethinylestradiol 20 μg/drospirenone 3 mg administered as a flexibleMIB, conventional 28-day or fixed extended regimen (full analysis set)
| Adverse event | FlexibleMIB (n=642) | Conventional 28-day (n=216) | Fixed extended (n=209) |
|---|---|---|---|
| At least one AE [n (%)] | 415 (64.6) | 150 (69.4) | 150 (71.8) |
| Treatment withdrawn due to AE [n (%)] | 57 (4.0) | 14 (2.5) | 29 (4.8) |
| AE* [n (%)] | |||
| Nasopharyngitis | 105 (16.4) | 45 (20.8) | 37 (17.7) |
| Headache | 82 (12.8) | 37 (17.1) | 37 (17.7) |
| Diarrhoea | 43 (6.7) | 16 (7.4) | 18 (8.6) |
| Cystitis | 21 (3.3) | 8 (3.7) | 17 (8.1) |
| Dysmenorrhoea | 29 (4.5) | 14 (6.5) | 9 (4.3) |
| Vomiting | 28 (4.4) | 7 (3.2) | 11 (5.3) |
| TAEs [n (%)] | 133 (20.7) | 56 (25.9) | 71 (34.0) |
| TAEs occurring in >3% [n (%)] | |||
| Headache | 33 (5.1) | 19 (8.8) | 18 (8.6) |
| Breast pain | 20 (3.1) | 7 (3.2) | 7 (3.3) |
| Dysmenorrhoea | 8 (1.2) | 9 (4.2) | 4 (1.9) |
| Lower abdominal pain | 7 (1.1) | 4 (1.9) | 9 (4.3) |
| Vaginal haemorrhage | 2 (0.3) | 0 (0) | 8 (3.8) |
↵* AEs (listed in order of overall frequency) are those that occurred in >5% of women in any of the three groups.
The full analysis set was defined as all subjects who received at least one dose of study medication and had at least one clinical observation after administration of study medication.
AE, adverse event; MIB, management of intracyclic (breakthrough) bleeding; TAE, treatment-related adverse event.