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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S15270 R62755 |
Desrochers, 2022 | Any malformations | 1st trimester | retrospective cohort (claims database) | unexposed (general population or NOS) | Adjustment: Yes | 1.17 [0.91;1.50] | -/- -/288,357 | - | - |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8505 R27981 |
The NAAED (Controls exposed to Lamotrigine, sick) (Indications NOS), 2022 | Major congenital malformations | 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
0.63 [0.19;2.04] C excluded (control group) |
3/251 44/2,333 | 47 | 251 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8506 R27983 |
The NAAED (Controls unexposed, disease free) (Indications NOS), 2022 | Major congenital malformations | 1st trimester | prospective cohort | unexposed, disease free | Adjustment: No | 1.20 [0.34;4.28] C | 3/251 12/1,201 | 15 | 251 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8495 R27908 |
Tomson, 2018 | Malformed Offspring | at least 1st trimester | prospective cohort | exposed to other treatment, sick | Adjustment: No | 0.94 [0.13;6.97] C | 1/36 74/2,514 | 75 | 36 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8491 R27888 |
Miškov (Controls unexposed, disease free), 2016 | Congenital anomalies | during pregnancy (anytime or not specified) | prospective cohort | unexposed, disease free excluded | Adjustment: No |
765.00 [11.05;52971.87] C excluded (control group) |
1/2 0/128 | 1 | 2 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8492 R27894 |
Miškov (Controls unexposed, sick), 2016 | Congenital anomalies | during pregnancy (anytime or not specified) excluded | prospective cohort | unexposed, sick | Adjustment: No |
21.00 [0.27;1646.32] C excluded (exposition period) |
1/2 0/4 | 1 | 2 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8485 R27857 |
Arkilo, 2015 | Major malformations | during pregnancy (anytime or not specified) excluded | retrospective cohort | exposed to other treatment, sick | Adjustment: No |
47.00 [0.38;5814.69] C excluded (exposition period) |
0/1 0/24 | 0 | 1 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8507 R27985 |
Källén (Controls exposed to Lamotrigine, sick) (Indications NOS), 2013 | Relatively severe malformations | early pregnancy | population based cohort retrospective | exposed to other treatment, sick excluded | Adjustment: No |
0.48 [0.12;2.03] C excluded (control group) |
2/119 37/1,084 | 39 | 119 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8508 R27987 |
Källén (Controls unexposed, NOS) (Indications NOS), 2013 | Relatively severe malformations | early pregnancy | population based cohort retrospective | unexposed (general population or NOS) | Adjustment: No | 0.53 [0.13;2.13] C | 2/119 49,499/1,575,847 | 49,501 | 119 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8496 R35195 |
Vajda (Controls exposed to Lamotrigine, sick), 2013 | Fetal malformations | at least 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
0.83 [0.05;14.66] C excluded (control group) |
0/14 13/315 | 13 | 14 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8497 R35196 |
Vajda (Controls unexposed, sick), 2013 | Fetal malformations | at least 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 0.95 [0.05;18.18] C | 0/14 5/147 | 5 | 14 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8487 R27875 |
Mawer (Controls exposed to Lamotrigine, sick), 2010 | Major malformations | 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
4.60 [0.15;144.69] C excluded (control group) |
0/2 2/37 | 2 | 2 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8488 R27877 |
Mawer (Controls unexposed, disease free), 2010 | Major malformations | 1st trimester | prospective cohort | unexposed, disease free excluded | Adjustment: No Matched |
14.28 [0.53;384.83] C excluded (control group) |
0/2 6/285 | 6 | 2 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8489 R27879 |
Mawer (Gabapentin) (Controls unexposed, sick), 2010 | Major malformations | 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 8.78 [0.24;318.70] C | 0/2 1/41 | 1 | 2 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8493 R27904 |
Morrow (Controls exposed to Lamotrigine, sick), 2006 | Major congenital malformation | 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
0.99 [0.13;7.64] C excluded (control group) |
1/31 21/647 | 22 | 31 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8494 R27906 |
Morrow (Controls unexposed, sick), 2006 | Major congenital malformation | 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 0.91 [0.11;7.55] C | 1/31 8/227 | 9 | 31 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S8486 R27873 |
Dean, 2002 | Congenital malformations (major and minor) | at least 1st trimester | retrospective cohort | unexposed, sick | Adjustment: No | 4.07 [0.07;222.16] C | 0/1 7/38 | 7 | 1 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Total | 8 studies | 1.15 [0.91;1.46] | 49,613 | 454 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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, disease free) (Indications NOS; 2: Controls unexposed, NOS) (Indications NOS; 3: Controls unexposed, sick; 4: Gabapentin) (Controls unexposed, sick; 5: Controls unexposed, sick;
Asymetry test p-value = 0.8605 (by Egger's regression)
slope=0.1286 (0.1066); intercept=0.0573 (0.3123); t=0.1835; p=0.8605
excluded 8493, 8487, 8488, 8507, 8496, 8491, 8505