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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S9803 R35086 |
Vajda (Vigabatrin) (Controls exposed to Lamotrigine, sick), 2019 | Fetal malformations | at least 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
18.80 [0.36;971.86] C excluded (control group) |
0/1 20/406 | 20 | 1 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9804 R35087 |
Vajda (Vigabatrin) (Controls unexposed, sick), 2019 | Fetal malformations | at least 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 31.00 [0.56;1711.11] C | 0/1 5/176 | 5 | 1 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9802 R35084 |
Tomson (Vigabatrin), 2018 | Malformed Offspring | at least 1st trimester | prospective cohort | exposed to other treatment, sick | Adjustment: No | 4.68 [0.24;91.38] C | 0/4 74/2,514 | 74 | 4 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9795 R35064 |
Källén (Vigabatrin) (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 |
1.86 [0.10;33.18] C excluded (control group) |
0/8 37/1,084 | 37 | 8 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9796 R35066 |
Källén (Vigabatrin) (Controls unexposed, NOS) (Indications NOS), 2013 | Relatively severe malformations | early pregnancy | population based cohort retrospective | unexposed (general population or NOS) | Adjustment: No | 2.06 [0.12;36.00] C | 0/8 49,499/1,575,847 | 49,499 | 8 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9797 R35068 |
Mawer (Vigabatrin) (Controls exposed to Lamotrigine, sick), 2010 | Major malformations | 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
13.80 [0.22;853.65] C excluded (control group) |
0/1 2/37 | 2 | 1 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9798 R35070 |
Mawer (Vigabatrin) (Controls unexposed, disease free), 2010 | Major malformations | 1st trimester | prospective cohort | unexposed, disease free excluded | Adjustment: No Matched |
42.85 [0.79;2330.91] C excluded (control group) |
0/1 6/285 | 6 | 1 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9799 R35072 |
Mawer (Vigabatrin) (Controls unexposed, sick), 2010 | Major malformations | 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 26.33 [0.38;1837.92] C | 0/1 1/41 | 1 | 1 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9800 R35074 |
Morrow (Vigabatrin) (Controls exposed to Lamotrigine, sick), 2006 | Major congenital malformation | 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
2.64 [0.14;49.38] C excluded (control group) |
0/6 21/647 | 21 | 6 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9801 R35082 |
Morrow (Vigabatrin) (Controls unexposed, sick), 2006 | Major congenital malformation | 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 2.34 [0.12;45.78] C | 0/6 8/227 | 8 | 6 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Total | 5 studies | 5.04 [1.16;21.81] | 49,587 | 20 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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: Vigabatrin) (Controls unexposed, sick; 2: Vigabatrin; 3: Vigabatrin) (Controls unexposed, NOS) (Indications NOS; 4: Vigabatrin) (Controls unexposed, sick; 5: Vigabatrin) (Controls unexposed, sick;
Asymetry test p-value = 0.0108 (by Egger's regression)
slope=-4.6716 (1.1199); intercept=3.8109 (0.6700); t=5.6882; p=0.0108
excluded 9800, 9797, 9798, 9795, 9803