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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S15225 R62458 |
Lyons (Topiramate) (Indications NOS), 2023 | Oral clefts | 1st trimester | retrospective cohort (claims database) | unexposed (general population or NOS) | Adjustment: Yes | 3.50 [1.64;7.46] | -/- 1,314/1,066,086 | 1,305 | - |
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S10173 R46499 |
Blotière (Topiramate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2019 | Oro-facial clefts | 1st trimester | retrospective cohort (claims database) | exposed to other treatment, sick excluded | Adjustment: No |
4.37 [0.97;19.57] C excluded (control group) |
3/517 4/2,997 | 7 | 517 |
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S10048 R46494 |
Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 | Oro-facial clefts | 1st trimester | retrospective cohort (claims database) | unexposed (general population or NOS) | Adjustment: No | 3.88 [1.25;12.09] C | 3/517 2,815/1,875,733 | 2,818 | 517 |
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S8605 R28687 |
Hernandez-Diaz (Topiramate) (Mixed indications), 2018 | Oral clefts | 1st trimester | prospective cohort | unexposed (general population or NOS) | Adjustment: Yes | 2.69 [1.28;5.64] | -/1,790 1,501/1,322,955 | 1,492 | 1,790 |
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S8575 R28528 |
Tomson (Topiramate), 2018 | Cleft lip or palate | at least 1st trimester | prospective cohort | exposed to other treatment, sick | Adjustment: No | 2.37 [0.12;46.04] C | 0/152 3/2,514 | 3 | 152 |
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S8616 R28776 |
Mines (Topiramate) (Other indications), 2014 | Oral cleft | 1st trimester | retrospective cohort (claims database) | unexposed, sick | Adjustment: Yes | 2.20 [0.80;6.40] | 5/1,745 20/13,512 | 25 | 1,745 |
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S8594 R28608 |
Veiby (Topiramate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 | Orofacial clefts | throughout pregnancy | population based cohort retrospective | exposed to other treatment, sick | Adjustment: No | 5.84 [0.23;145.17] C | 0/48 1/833 | 1 | 48 |
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S10221 R37446 |
Hernández-Díaz (Topiramate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2012 | Oral clefts | 1st trimester | prospective cohort | exposed to other treatment, sick | Adjustment: No | 3.14 [0.99;9.94] C | 5/359 7/1,562 | 12 | 359 |
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S8569 R28509 |
Morrow (Topiramate) (Controls exposed to Lamotrigine, sick), 2006 | Facial cleft | 1st trimester | prospective cohort | exposed to other treatment, sick | Adjustment: No | 23.93 [1.46;392.85] C | 1/28 1/647 | 2 | 28 |
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Total | 8 studies | 3.15 [2.12;4.69] | 5,658 | 4,639 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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: Topiramate) (Indications NOS; 2: Topiramate) (Controls unexposed NOS) (Mixed indications; 3: Topiramate) (Mixed indications; 4: Topiramate; 5: Topiramate) (Other indications; 6: Topiramate) (Controls exposed to Lamotrigine, sick) (Mixed indications; 7: Topiramate) (Controls exposed to Lamotrigine, sick) (Mixed indications; 8: Topiramate) (Controls exposed to Lamotrigine, sick;
Asymetry test p-value = 0.1950 (by Egger's regression)
slope=0.7862 (0.2778); intercept=0.7074 (0.4851); t=1.4583; p=0.1950
excluded 10173