Table 4.
Treatment-emergent adverse events by system organ class
| 2012 EGKINETIC4 | 2012 EGKINETIC6 | EGKINETIC6OP | ||||
|---|---|---|---|---|---|---|
| E2 BID | E4 OD | EC2 TID | ES6 OD | ES6 OD | E6 OD | |
| (N = 22) | (N = 22) | (N = 22) | (N = 22) | (N = 30) | (N = 29) | |
| n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | |
| Endocrine disorders | 0 | 0 | 1 (4.5%) | 0 | 0 | 0 |
| Gastrointestinal disorders | 3 (13.6%) | 3 (13.6%) | 1 (4.5%) | 1 (4.5%) | 0 | 1 (3.4%) |
| General disorders and administration site conditions | 0 | 0 | 2 (9.1%) | 1 (4.5%) | 0 | 0 |
| Infections and infestations | 3 (13.6%) | 2 (9.1%) | 0 | 0 | 0 | 1 (3.4%) |
| Injury, poisoning and procedural complications | 1 (4.5%) | 1 (4.5%) | 0 | 0 | 0 | 0 |
| Metabolism and nutrition disorders | 0 | 0 | 1 (4.5%) | 0 | 0 | 0 |
| Nervous system disorders | 1 (4.5%) | 1 (4.5%) | 2 (9.1%) | 3 (13.6%) | 1 (3.3%) | 3 (10.3%) |
| Reproductive system and breast disorders | 2 (9.1 %) | 3 (13.6%) | 1 (4.5%) | 1 (4.5%) | 0 | 0 |
| Respiratory, thoracic and mediastinal disorders | 1 (4.5%) | 1 (4.5%) | 0 | 4 (18.2%) | 0 | 0 |