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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S7788 R35183 |
Vajda (Primidone) (Controls exposed to Lamotrigine, sick), 2019 | Fetal malformations | at least 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
6.27 [0.25;158.67] C excluded (control group) |
0/2 20/406 | 20 | 2 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S7789 R35184 |
Vajda (Primidone) (Controls unexposed, sick), 2019 | Fetal malformations | at least 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 10.33 [0.38;283.37] C | 0/2 5/176 | 5 | 2 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S7666 R27001 |
Tomson (Primidone), 2018 | Malformed Offspring | at least 1st trimester | prospective cohort | exposed to other treatment, sick | Adjustment: No | 2.67 [0.81;8.87] C | 3/40 74/2,514 | 77 | 40 |
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S6502 R35128 |
Bànhidy (Primidone), 2011 | Total congenital abnormalities | throughout pregnancy | case control | unexposed, sick | Adjustment: No Matched | 0.56 [0.12;2.54] C | 4/10 12/22 | 16 | 10 |
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S6622 R18194 |
Burja (Primidone) (Controls unexposed, disease free), 2006 | Congenital malformation | during pregnancy (anytime or not specified) | retrospective cohort (registry) | unexposed, disease free excluded | Adjustment: No |
37.36 [0.68;2061.38] C excluded (control group) |
0/1 5/211 | 5 | 1 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S6618 R18174 |
Burja (Primidone) (Controls unexposed, sick), 2006 | Congenital malformation | during pregnancy (anytime or not specified) excluded | retrospective cohort (registry) | unexposed, sick | Adjustment: No |
63.00 [0.51;7760.63] C excluded (exposition period) |
0/1 0/32 | 0 | 1 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S6140 R26996 |
Kaaja (Primidone), 2003 | Major malformation | 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 23.70 [1.83;306.18] C | 1/6 2/239 | 3 | 6 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S6681 R18544 |
Dean (Primidone), 2002 | Congenital malformations (major and minor) | at least 1st trimester | retrospective cohort | unexposed, sick | Adjustment: No | 1.36 [0.05;36.71] C | 0/2 7/38 | 7 | 2 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S7174 R26580 |
Canger (Primidone), 1999 | All type of malformation | 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 5.44 [0.27;110.44] C | 3/35 0/25 | 3 | 35 |
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S6444 R17698 |
Kaneko (Primidone), 1999 | Malformations | throughout pregnancy | prospective cohort | unexposed, sick | Adjustment: No | 5.28 [1.19;23.40] C | 5/35 3/98 | 8 | 35 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S6711 R26999 |
Samrén (Primidone), 1999 | Major congential abnormalities | at least 1st trimester | retrospective cohort | unexposed, disease free | Adjustment: No Matched | 1.91 [0.11;32.49] C | 0/18 29/2,000 | 29 | 18 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S6710 R27000 |
Steegers-Theunissen (Primidone), 1994 | Major malformations (ICD9 British Paediatric Association System) | during pregnancy (anytime or not specified) excluded | prospective cohort | unexposed, disease free | Adjustment: No |
69.67 [1.01;4827.79] C excluded (exposition period) |
1/1 2/106 | 3 | 1 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S6587 R18066 |
Lowe (Primidone) (Controls unexposed, disease free), 1973 | Malformations | 1st trimester | population based cohort retrospective | unexposed, disease free excluded | Adjustment: No |
5.08 [0.26;98.39] C excluded (control group) |
0/4 865/31,632 | 865 | 4 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S6590 R18072 |
Lowe (Primidone) (Controls unexposed, sick), 1973 | Malformations | 1st trimester | population based cohort retrospective | unexposed, sick | Adjustment: No | 4.39 [0.19;102.26] C | 0/4 3/111 | 3 | 4 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Total | 9 studies | 2.88 [1.39;5.95] | 151 | 152 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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: Primidone) (Controls unexposed, sick; 2: Primidone; 3: Primidone; 4: Primidone; 5: Primidone; 6: Primidone; 7: Primidone; 8: Primidone; 9: Primidone) (Controls unexposed, sick;
Asymetry test p-value = 0.4001 (by Egger's regression)
slope=0.2423 (0.9514); intercept=0.8355 (0.9328); t=0.8958; p=0.4001
excluded 6587, 6622, 7788