Table 4. Incidence of OHSS by grade in the two trials and combined.
| Progesterone s.c | Progesterone vaginal | Total | P-value | ||
|---|---|---|---|---|---|
| 07EU/Prg06 | Number of patients | 322 | 331 | 653 | 0.578 |
| Total number of events | 5 (1.55%) | 8 (2.42%) | 13 (1.99%) | ||
| Mild | 1 (0,31%) | 2 (0,60%) | 3 (0,46%) | ||
| Moderate | 1 (0,31%) | 5 (1,51%) | 6 (0,92%) | ||
| Severe | 3 (0,93%) | 1 (0,30%) | 4 (0,61%) | ||
| 07USA/Prg05 | Number of patients | 392 | 390 | 782 | 0.627 |
| Total number of events | 22 (5.61%) | 18 (4.62%) | 40 (5.12%) | ||
| Mild | 11 (2,81%) | 8 (2,05%) | 19 (2,43%) | ||
| Moderate | 9 (2,30%) | 7 (1,79%) | 16 (2,05%) | ||
| Severe | 2 (0,51%) | 3 (0,77%) | 5 (0,64%) | ||
| Combined | Number of patients | 714 | 721 | 1435 | 0.889* |
| Total number of events | 27 (3.78%) | 26 (3.61%) | 53 (3.69%) | ||
| Mild | 12 (1.68%) | 10 (1.39%) | 22 (1.53%) | 0.674** | |
| Moderate | 10 (1.40%) | 12(1.66%) | 22 (1.53%) | 0.831*** | |
| Severe | 5 (0.70%) | 4 (0.55%) | 9 (0.63%) | 0.752**** |
*χ2 test on the number of OHSS events considering the study as covariate p = 0.880
**χ2 test on the number of mild OHSS events considering the study as covariate p = 0.668
***χ2 test on the number of moderate OHSS events considering the study as covariate p = 0.674
****χ2 test on the number of OHSS events considering the study as covariate p = 0.728