id | Study | Lib. in paper | Exposition period | Study type |
Control type |
Tags | OR 95%CI | x1/n1 x0/n0 | no cases | no exposed | ROB | Ref. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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S18393 R77618 |
Chan (Controls exposed to FGA), 2024 | Major congenital malformations | at least 1st trimester | retrospective cohort (claims database) | exposed to other treatment, sick excluded | Adjustment: No |
1.51 [0.90;2.54] C excluded (control group) |
38/419 26/420 | 64 | 419 |
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S18339 R77619 |
Chan (Controls unexposed, general pop), 2024 | Major congenital malformations | at least 1st trimester | retrospective cohort (claims database) | unexposed (general population or NOS) excluded | Adjustment: Yes |
2.11 [1.19;3.86] excluded (control group) |
38/419 22,929/464,017 | 22,967 | 419 |
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S18392 R77620 |
Chan (Controls unexposed, sick), 2024 | Major congenital malformations | at least 1st trimester | retrospective cohort (claims database) | unexposed, sick | Adjustment: Yes | 2.14 [1.16;4.12] | 34/363 385/6,476 | 419 | 363 |
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S18401 R77650 |
Kernizan (Controls exposed to LTG), 2024 | Malformations | during pregnancy (anytime or not specified) | retrospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
0.27 [0.02;4.58] C excluded (control group) |
1/46 1/13 | 2 | 46 |
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S18348 R77613 |
Kernizan (Controls unexposed, sick), 2024 | Malformations | during pregnancy (anytime or not specified) excluded | retrospective cohort | unexposed, sick | Adjustment: No |
0.32 [0.04;2.60] C excluded (exposition period) |
1/46 9/139 | 10 | 46 |
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S14276 R56342 |
Huybrechts (Controls unexposed, NOS), 2023 | Major congenital malformations overall (excluding chromosomal abnormality) | 1st trimester | population based cohort retrospective | unexposed (general population or NOS) excluded | Adjustment: Yes |
1.05 [0.98;1.11] excluded (control group) |
941/21,751 177,165/6,455,324 | 178,106 | 21,751 |
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S14299 R56355 |
Huybrechts (Controls unexposed, sick), 2023 | Major congenital malformations overall (excluding chromosomal abnormality) | 1st trimester | population based cohort retrospective | unexposed, sick | Adjustment: Yes | 1.07 [1.00;1.15] | 764/17,068 11,647/318,731 | 12,411 | 17,068 |
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S12456 R46740 |
Cohen, 2022 | Major malformations | 1st trimester | prospective cohort | exposed to other treatment, sick | Adjustment: No | 1.79 [0.96;3.32] | 22/810 19/1,234 | 41 | 810 |
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S12436 R46698 |
Anderson, 2020 | Major birth defects (one of the 30 studied) | 1st trimester | case control | unexposed (general population or NOS) | Adjustment: No | 1.54 [0.80;2.96] C | 36/48 22,351/33,809 | 22,387 | 48 |
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S12447 R56343 |
Yakuwa, 2019 | Major malformation (in live births) | 1st trimester | prospective cohort | unexposed (general population or NOS) | Adjustment: No | 0.75 [0.30;1.86] C | 5/351 74/3,901 | 79 | 351 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S2360 R11452 |
Raguideau, 2017 | 26 major malformations | early pregnancy | retrospective cohort (claims database) | unexposed (general population or NOS) | Adjustment: No | 1.65 [1.19;2.28] C | 37/2,286 18,682/1,888,130 | 18,719 | 2,286 |
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S3876 R11449 |
Ozturk, 2016 | Major birth defects | during pregnancy (anytime or not specified) excluded | retrospective cohort | unexposed (general population or NOS) | Adjustment: No |
3.01 [0.15;61.83] C excluded (exposition period) |
0/12 3/246 | 3 | 12 |
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S2398 R11451 |
Petersen (Control unexposed, disease free), 2016 | Major malformations | 1st trimester | retrospective cohort (claims database) | unexposed, disease free | Adjustment: No | 1.77 [0.83;3.77] C | 7/203 4,162/210,966 | 4,169 | 203 |
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S2329 R2695 |
Bellet - Aripiprazole, 2015 | All malformations (minor and major) | 1st trimester | prospective cohort | unexposed (general population or NOS) | Adjustment: No | 2.03 [0.66;6.28] | 6/71 7/161 | 13 | 71 |
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S2294 R8228 |
Vigod, 2015 | Congenital malformations | 1st trimester | retrospective cohort (claims database) | unexposed, sick | Adjustment: Yes Matched | 1.37 [0.82;2.29] | 40/893 33/893 | 73 | 893 |
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S2341 R11445 |
Habermann (Control exposed to FGA), 2013 | Major malformations | 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: Yes |
1.27 [0.57;2.82] excluded (control group) |
22/430 9/213 | 31 | 430 |
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S2385 R11446 |
Habermann (Control unexposed, disease free), 2013 | Major malformations | 1st trimester | prospective cohort | unexposed, disease free | Adjustment: Yes | 2.17 [1.20;3.91] | 22/430 25/1,014 | 47 | 430 |
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S2332 R11450 |
Peng, 2013 | Major malformations | throughout pregnancy | prospective cohort | unexposed, disease free | Adjustment: No Matched | 1.00 [0.02;51.06] C | 0/76 0/76 | 0 | 76 |
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S2286 R11455 |
Sadowski, 2013 | Major malformations | during pregnancy (anytime or not specified) excluded | prospective cohort | unexposed, disease free | Adjustment: No Matched |
2.49 [0.63;9.87] C excluded (exposition period) |
7/113 3/116 | 10 | 113 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S2391 R11457 |
Vial (Control exposed to FGA), 2009 | Major malformations | 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No Matched |
0.42 [0.09;2.03] excluded (control group) |
2/66 8/117 | 10 | 66 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S2390 R11458 |
Vial (Control unexposed, NOS), 2009 | Major malformations | 1st trimester | prospective cohort | unexposed (general population or NOS) | Adjustment: No | 1.63 [0.27;9.99] | 2/66 3/159 | 5 | 66 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S2384 R11453 |
Reis (Control exposed to FGA), 2008 | Relatively severe malformations | early pregnancy | population based cohort retrospective | exposed to other treatment, sick excluded | Adjustment: No |
0.84 [0.33;2.12] C excluded (control group) |
6/147 21/435 | 27 | 147 |
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S2333 R11454 |
Reis (Control unexposed, NOS), 2008 | Relative severe malformations | early pregnancy | population based cohort retrospective | unexposed (general population or NOS) | Adjustment: No | 1.31 [0.58;2.96] C | 6/147 30,679/973,767 | 30,685 | 147 |
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S2305 R11448 |
McKenna, 2005 | Major malformations | 1st trimester | prospective cohort | unexposed, disease free | Adjustment: No Matched | 0.61 [0.05;6.82] C | 1/110 2/135 | 3 | 110 |
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Total | 14 studies | 1.46 [1.18;1.81] | 89,051 | 22,922 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
x1: number of endpoints among exposed, n1: number of exposed; x0: number of endpoints among non exposed, n0: number of non exposed; C: calculated odds ratio from numbers of events and effectives |
1: Controls unexposed, sick; 2: Controls unexposed, sick; 3: Control unexposed, disease free; 4: Control unexposed, disease free; 5: Control unexposed, NOS; 6: Control unexposed, NOS;
Asymetry test p-value = 0.0141 (by Egger's regression)
slope=0.0523 (0.0429); intercept=0.9857 (0.3436); t=2.8685; p=0.0141
excluded 2384, 2391, 2341, 14276, 18393, 18339, 18401