Table 4.
Summary of adverse events for women enrolled in a phase 3, multicenter, 13-cycle trial of a drospirenone 4 mg 24/4-day contraceptive regimen (n = 1006; safety set)
| Women, n (%) | Events, n | |
|---|---|---|
| Women with at least 1 AE | 667 (66.3) | 2008 |
| Women with at least 1 TEAE | 614 (61.0) | 1771 |
| Women with at least 1 related TEAEa | 341 (33.9) | 640 |
| Women with at least 1 serious AE | 17 (1.7) | 32 |
| Women with at least 1 serious TEAE | 15 (1.5) | 24 |
| Women with at least 1 serious related TEAE | 3 (0.3) | 3 |
| Women with at least 1 TEAE leading to trial discontinuation | 113 (11.2) | 163 |
| Women with at least 1 related TEAE leading to trial discontinuation | 100 (9.9) | 123 |
| Deaths | 0 | 0 |
| Frequency of women with TEAEs ≥ 2.0% | ||
| Nasopharyngitis | 77 (7.7) | 87 |
| Headache | 64 (6.4) | 72 |
| Nausea | 63 (6.3) | 64 |
| Dysmenorrhea | 58 (5.8) | 62 |
| Metrorrhagia | 53 (5.3) | 54 |
| Breast pain | 51 (5.1) | 54 |
| Upper respiratory tract infection | 36 (3.6) | 38 |
| Acne | 35 (3.5) | 36 |
| Urinary tract infection | 34 (3.4) | 36 |
| Weight increase | 34 (3.4) | 34 |
| Breast tenderness | 33 (3.3) | 34 |
| Cervical dysplasia | 29 (2.9) | 39 |
| Abdominal pan | 26 (2.6) | 28 |
| Vulvovaginal mycotic infection | 24 (2.4) | 24 |
| Diarrhea | 23 (2.3) | 23 |
| Sinusitis | 22 (2.2) | 25 |
a
Related TEAEs were “possibly related,” “probably related” or “definitely related” as assessed by the investigator.