Table 1.
Relevant obstetrical outcomes and events occurring in ≥2% of the women in the 17P group or at a higher rate in the 17P versus Placebo group.
| Meis a | PROLONG b | Integrated | ||||
|---|---|---|---|---|---|---|
| 17P N = 310 n (%) | Placebo N = 153 n (%) | 17P N = 1128 n (%) | Placebo N = 578 n (%) | 17P N = 1438 % | Placebo N = 731 % | |
| Admission for preterm labor (other than delivery admission) | 49 (16.0)c | 21 (13.8) | 187 (16.5)c | 84 (14.5) | 16.4c | 14.4 |
| Preeclampsia or gestational hypertension | 27 (8.8)c | 7 (4.6) | 47 (4.2)c | 30 (5.2) | 5.2c | 5.1 |
| Nausea | 18 (5.8) | 7 (4.6) | 55 (4.9) | 26 (4.5) | 5.1 | 4.5 |
| Gestational diabetes | 17 (5.6)c | 7 (4.6) | 35 (3.1)c | 21 (3.6) | 3.6c | 3.8 |
| Headache | 4 (1.3) | 0 | 68 (6.0) | 28 (4.8) | 5.0 | 3.8 |
| Injection site pruritus | 18 (5.8) | 5 (3.3) | 42 (3.7) | 23 (4.0) | 4.2 | 3.8 |
| Injection site swelling | 53 (17.1) | 12 (7.8) | 5 (0.4) | 2 (0.3) | 4.0 | 1.9 |
| Back pain | 4 (1.3) | 1 (0.7) | 50 (4.4) | 20 (3.5) | 3.8 | 2.9 |
| Vomiting | 10 (3.2) | 5 (3.3) | 42 (3.7) | 19 (3.3) | 3.6 | 3.3 |
| Urticaria | 38 (12.3) | 17 (11.1) | 5 (0.4) | 0 | 3.0 | 2.3 |
| Constipation | 2 (0.6) | 1 (0.7) | 38 (3.4) | 17 (2.9) | 2.8 | 2.5 |
| Insomnia | 2 (0.6) | 1 (0.7) | 36 (3.2) | 13 (2.2) | 2.6 | 1.9 |
| Cervical incompetence/cerclage | 5 (1.6) | 2 (1.3) | 34 (3.0) | 16 (2.8) | 2.4 | 2.2 |
| Injection site nodule | 14 (4.5) | 3 (2.0) | 18 (1.6) | 9 (1.6) | 2.2 | 1.6 |
| Diarrhea | 7 (2.3) | 1 (0.7) | 23 (2.0) | 13 (2.2) | 2.1 | 1.9 |
| Oligohydramniosd | 11 (3.6)c | 2 (1.3) | 9 (0.8)c | 12 (2.1) | 1.4c | 1.9 |
| Chorioamnionitisd | 11 (3.6)c | 5 (3.3) | 9 (0.8)c | 2 (0.3) | 1.4c | 1.0 |
| Cholestasisd | 0 | 0 | 3 (0.3) | 5 (0.9) | 0.2 | 0.7 |
| Maternal depressione | 0 | 0 | 5 (0.4) | 5 (0.9) | 0.3 | 0.7 |
| VTEd | 1 (0.3) | 0 | 0 | 1 (0.2) | 0.07 | 0.1 |
17P 17-α-hydroxyprogesterone caproate, VTE venous thromboembolism.
bReference [10].
cN = 306 as denominator for these AEs for Meis; N = 1130 as denominator for these AEs for PROLONG.
dIncluded in table given medical relevance for this therapeutic class.
eIncluded in table given reference in the product insert. Maternal depression was based on AE reporting.