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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S10103 R36814 |
Coste (Topiramate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2020 | Gestational age at birth (< 37 WA) | during pregnancy (anytime or not specified) | retrospective cohort (claims database) | exposed to other treatment, sick excluded | Adjustment: No |
1.23 [0.85;1.78] C excluded (control group) |
36/477 182/2,916 | 218 | 477 |
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S8613 R28732 |
Coste (Topiramate) (Controls unexposed, NOS) (Mixed indications), 2020 | Gestational age at birth (< 37 WA) | during pregnancy (anytime or not specified) | retrospective cohort (claims database) | unexposed (general population or NOS) | Adjustment: No | 1.45 [1.03;2.03] C | 36/477 91,255/1,710,441 | 91,291 | 477 |
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S8592 R28597 |
Cohen (Topiramate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2019 | Preterm birth (ICD-9 644.2, 774.2, 776.6, 362.20, 362.22, 362.27, 765 excluding 765.20, 765.29) | early pregnancy | retrospective cohort (claims database) | exposed to other treatment, sick excluded | Adjustment: Yes |
0.90 [0.70;1.17] excluded (control group) |
305/2,280 392/2,682 | 697 | 2,280 |
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S8593 R28604 |
Cohen (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 | Preterm birth (ICD-9 644.2, 774.2, 776.6, 362.20, 362.22, 362.27, 765 excluding 765.20, 765.29) | early pregnancy | retrospective cohort (claims database) | unexposed (general population or NOS) | Adjustment: Yes | 0.89 [0.80;1.00] | 305/2,280 160,604/1,440,631 | 160,909 | 2,280 |
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S8602 R28634 |
Bank (Topiramate) (Mixed indications) , 2017 | Premature (<37 weeks gestation) | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick | Adjustment: No | 35.00 [1.16;1060.29] C | 1/2 1/36 | 2 | 2 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8554 R28459 |
Arkilo (Topiramate), 2015 | Premature delivery | during pregnancy (anytime or not specified) | retrospective cohort | exposed to other treatment, sick | Adjustment: No | 1.95 [0.07;58.24] C | 0/2 3/24 | 3 | 2 |
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S8599 R28627 |
Hernández-Díaz (Topiramate) (Mixed indications) (Controls exposed to Lamotrigine, sick), 2014 | Preterm (< 37 weeks) | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
1.42 [0.96;2.11] C excluded (control group) |
36/347 119/1,581 | 155 | 347 |
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S8600 R28630 |
Hernández-Díaz (Topiramate) (Mixed indications) (Controls unexposed, disease free), 2014 | Preterm (< 37 weeks) | during pregnancy (anytime or not specified) | prospective cohort | unexposed, disease free | Adjustment: No | 1.84 [1.10;3.10] C | 36/347 27/457 | 63 | 347 |
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S8608 R28702 |
Kilic (Topiramate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 | Preterm (< 37 weeks) | during pregnancy (anytime or not specified) | population based cohort retrospective | exposed to other treatment, sick excluded | Adjustment: No |
0.89 [0.35;2.28] C excluded (control group) |
5/59 83/880 | 88 | 59 |
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S8609 R28705 |
Kilic (Topiramate) (Controls unexposed NOS) (Mixed indications), 2014 | Preterm (< 37 weeks) | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed (general population or NOS) excluded | Adjustment: No |
1.75 [0.70;4.38] C excluded (control group) |
5/59 33,974/676,834 | 33,979 | 59 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8610 R28708 |
Kilic (Topiramate) (Controls unexposed, sick) (Mixed indications), 2014 | Preterm (< 37 weeks) | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed, sick | Adjustment: No Controls: epilepsy indication | 1.19 [0.47;2.99] C | 5/59 383/5,296 | 388 | 59 |
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Total | 6 studies | 1.34 [0.87;2.05] | 252,656 | 3,167 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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) (Controls unexposed, NOS) (Mixed indications; 2: Topiramate) (Controls unexposed NOS) (Mixed indications; 3: Topiramate) (Mixed indications; 4: Topiramate; 5: Topiramate) (Mixed indications) (Controls unexposed, disease free; 6: Topiramate) (Controls unexposed, sick) (Mixed indications;
Asymetry test p-value = 0.0594 (by Egger's regression)
slope=-0.1883 (0.0898); intercept=1.8186 (0.6967); t=2.6102; p=0.0594
excluded 8599, 8608, 8609, 8592, 10103