Analysis including pregnancies terminated due to congenital malformations (2007-2013), prespecified
|
Number
|
521,037
|
432
| |
432
|
432
| |
Any major congenital malformation
|
16,692 (3.2%)
|
22 (5.1%)
|
1.58 (1.03 to 2.44)
|
20 (4.6%)
|
22 (5.1%)
|
1.10 (0.60 to 2.02)
|
Congenital heart defects
|
3005 (0.6%)
|
8 (1.9%)
|
3.17 (1.57 to 6.40)
|
4 (0.9%)
|
8 (1.9%)
|
2.00 (0.60 to 6.64)
|
Pregnancies among women without an earlier pregnancy resulting in a malformed child, post hoc
|
Number
|
650,431
|
390
| |
381
|
381
| |
Any major malformation
|
23,712 (3.7%)
|
18 (4.6%)
|
1.26 (0.77 to 2.04)
|
20 (5.3%)
|
17 (4.5%)
|
0.84 (0.43 to 1.64)
|
Congenital heart defects
|
4598 (0.7%)
|
8 (2.1%)
|
2.68 (1.27 to 5.68)
|
5 (1.3%)
|
7 (1.8%)
|
1.50 (0.42 to 5.32)
|
First trimester exposure to oseltamivir, defined as oseltamivir dispensing during 4-10 weeks of gestation, post hoc
|
Number
|
670,602
|
212
| |
205
|
205
| |
Any major malformation
|
24,773 (3.7%)
|
8 (3.8%)
|
0.91 (0.43 to 1.95)
|
8 (3.9%)
|
7 (3.4%)
|
0.88 (0.32 to 2.41)
|
Congenital heart defects
|
4795 (0.7%)
|
5 (2.4%)
|
2.70 (1.00 to 7.29)
|
N/A
|
Oseltamivir dispensing in second or third trimester (post-organogenesis), prespecified
|
Number
|
670,602
|
1449
| |
1420
|
1420
| |
Any major malformation
|
24,773 (3.7%)
|
64 (4.4%)
|
1.18 (0.91 to 1.53)
|
51 (3.6%)
|
61 (4.3%)
|
1.21 (0.82 to 1.77)
|
Congenital heart defects
|
4795 (0.7%)
|
21 (1.5%)
|
2.10 (1.36 to 3.24)
|
6 (0.4%)
|
21 (1.5%)
|
3.50 (1.41 to 8.67)
|
Exposure to oseltamivir between 12 and 3 months preconception, post hoc
|
Number
|
669,934
|
538
| |
530
|
530
| |
Any major malformation
|
24,745 (3.7%)
|
24 (4.5%)
|
1.20 (0.80 to 1.80)
|
19 (3.6%)
|
24 (4.5%)
|
1.28 (0.69 to 2.37)
|
Congenital heart defects
|
N/A
|
First-trimester exposure to penicillin, post hocc
|
Number
|
471,117
|
70,309
| |
Analysis not conducted
|
Any major malformation
|
17,148 (3.6%)
|
2798 (4.0%)
|
1.09 (1.04 to 1.13)
|
Congenital heart defects
|
3296 (0.7%)
|
599 (0.9%)
|
1.17 (1.07 to 1.29)
|