Table 2.
Pregnancy outcomes in the daclizumab clinical study program
Pregnancies by outcomea | Became pregnant while receiving daclizumab or ≤6 months after the final dose | Stopped daclizumab treatment >6 months before becoming pregnant | Daclizumab dose status unknown at the time of becoming pregnant |
---|---|---|---|
Total number of pregnancies | 38 | 6 | 1 |
Total number of women who became pregnantb | 36c | 5d | 1 |
Live birth | 20 | 3 | 0 |
Spontaneous abortion/miscarriage | 4 | 2 | 0 |
Elective termination | 8 | 1 | 0 |
Ectopic pregnancy | 2 | 0 | 0 |
Lost to follow-up | 2 | 0 | 0 |
Outcome pending | 2 | 0 | 1 |
aBased on pregnancy reports from the daclizumab drug development program as of March 9, 2015
bFour women became pregnant more than once; two of these women became pregnant while receiving daclizumab or ≤6 months of receiving the final dose and then again >6 months after their final dose of daclizumab and are therefore counted in both columns
cOf the 36 women who became pregnant while receiving daclizumab or ≤6 months of receiving the final dose, 34 had one pregnancy (total pregnancies, n = 34) and two had two pregnancies in this category (total pregnancies, n = 4)
dIn the five women who became pregnant >6 months after their final dose of daclizumab, four had one pregnancy each (total pregnancies, n = 4) and one had multiple (n = 2) pregnancies in this category