Table 5.
Adverse events during the invasion phase, elimination phase, and the overall study (invasion + elimination phase)
| Treatment during invasion phase
|
||
|---|---|---|
| EE-drsp-levomefolate calcium | EE-drsp + folic acid | |
| Invasion phase | ||
| AEs, % | 96.5 | 95.3 |
| TEAEs, % | 30.2 | 15.1 |
| SAEs, n | 2 in 1 woman | 2 in 2 women |
| Elimination phase | ||
| AEs, % | 87.5 | 91.5 |
| TEAEs, % | 8.8 | 11.0 |
| SAEs, n | 9 in 5 women | 3 in 1 woman |
Abbreviations: AE, adverse event; drsp, drospirenone; EE, ethinylestradiol; SAE, serious AE; TEAE, treatment-emergent AE.