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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S16802 R70501 |
The NAAED (Phenobarbital) (Controls exposed to LTG) (Indications NOS), 2023 | Major congenital malformations | 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
2.96 [1.55;5.64] C excluded (control group) |
12/200 52/2,461 | 64 | 200 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S16803 R70503 |
The NAAED (Phenobarbital) (Controls unexposed, disease free) (Indications NOS), 2023 | Major congenital malformations | 1st trimester | prospective cohort | unexposed, disease free | Adjustment: No | 5.51 [2.54;11.96] C | 12/200 15/1,311 | 27 | 200 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12841 R48395 |
Thomas (Phenobarbital) (Controls exposed to Lamotrigine, sick), 2021 | Major congenital malformations | 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
3.04 [0.37;24.93] C excluded (control group) |
8/137 1/50 | 9 | 137 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12842 R48403 |
Thomas (Phenobarbital) (Controls unexposed, disease free), 2021 | Major congenital malformations | 1st trimester | prospective cohort | unexposed, disease free excluded | Adjustment: No |
1.57 [0.62;3.97] excluded (control group) |
7/129 11/319 | 18 | 129 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S12844 R48409 |
Thomas (Phenobarbital) (Controls unexposed, sick), 2021 | Major congenital malformations | 1st trimester | prospective cohort | unexposed, sick | Adjustment: Yes | 1.20 [0.50;2.70] | 8/137 16/340 | 24 | 137 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9587 R35167 |
Vajda (Phenobarbital or Primidone) (Controls exposed to Lamotrigine, sick), 2019 | Fetal malformations | at least 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
2.69 [0.13;53.76] C excluded (control group) |
0/4 20/406 | 20 | 4 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9588 R35168 |
Vajda (Phenobarbital or Primidone) (Controls unexposed, sick), 2019 | Fetal malformations | at least 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 4.43 [0.20;96.60] C | 0/4 5/176 | 5 | 4 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9586 R33952 |
Tomson (Phenobarbital or Primidone), 2018 | Major congenital malformation | at least 1st trimester | prospective cohort | exposed to other treatment, sick | Adjustment: No | 2.33 [1.42;3.80] C | 22/334 74/2,514 | 96 | 334 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9485 R33353 |
Barroso (Phenobarbital), 2015 | Major anomalies | during pregnancy (anytime or not specified) excluded | retrospective cohort | unexposed, disease free | Adjustment: No |
2.11 [0.68;6.62] C excluded (exposition period) |
4/32 20/316 | 24 | 32 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9506 R33535 |
Veiby (Phenobarbital) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 | Major congenital malformation | throughout pregnancy | population based cohort retrospective | exposed to other treatment, sick excluded | Adjustment: No |
2.30 [0.52;10.19] C excluded (control group) |
2/27 28/833 | 30 | 27 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9507 R33537 |
Veiby (Phenobarbital) (Controls unexposed, disease free) (Mixed indications), 2014 | Major malformations | throughout pregnancy | population based cohort retrospective | unexposed, disease free excluded | Adjustment: Yes |
2.75 [0.65;11.60] excluded (control group) |
2/27 22,371/771,412 | 22,373 | 27 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9566 R33872 |
Veiby (Phenobarbital) (Controls unexposed, sick) (Mixed indications), 2014 | Major malformations | throughout pregnancy | population based cohort retrospective | unexposed, sick | Adjustment: No Controls: epilepsy indication | 2.77 [0.65;11.84] C | 2/27 106/3,773 | 108 | 27 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9515 R33601 |
Cassina (Phenobarbital) (Controls exposed to Lamotrigine, sick) (Other indications), 2013 | Major congenital anomalies | 1st trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
6.43 [0.11;379.68] C excluded (control group) |
0/4 0/23 | 0 | 4 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9516 R33603 |
Cassina (Phenobarbital) (Controls unexposed, disease free) (Other indications), 2013 | Major congenital anomalies | 1st trimester | prospective cohort | unexposed, disease free | Adjustment: No | 4.36 [0.22;86.56] C | 0/4 25/803 | 25 | 4 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9572 R33910 |
Källén (Phenobarbital or Primidone) (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 |
2.36 [0.54;10.35] C excluded (control group) |
2/26 37/1,084 | 39 | 26 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9573 R33912 |
Källén (Phenobarbital or Primidone) (Controls unexposed, NOS) (Indications NOS), 2013 | Relatively severe malformations | early pregnancy | population based cohort retrospective | unexposed (general population or NOS) | Adjustment: No | 2.57 [0.61;10.87] C | 2/26 49,499/1,575,847 | 49,501 | 26 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9575 R35126 |
Bànhidy (Phenobarbital or Primidone), 2011 | Total congenital abnormalities | throughout pregnancy | case control | unexposed, sick | Adjustment: No Matched | 0.69 [0.16;2.97] C | 5/11 12/22 | 17 | 11 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9570 R33890 |
Burja (Phenobarbital or Primidone) (Controls unexposed, disease free), 2006 | Congenital malformation | during pregnancy (anytime or not specified) | retrospective cohort (registry) | unexposed, disease free excluded | Adjustment: No |
12.45 [0.45;341.34] C excluded (control group) |
0/2 5/211 | 5 | 2 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9568 R33880 |
Burja (Phenobarbital or Primidone) (Controls unexposed, sick), 2006 | Congenital malformation | during pregnancy (anytime or not specified) excluded | retrospective cohort (registry) | unexposed, sick | Adjustment: No |
21.00 [0.30;1469.95] C excluded (exposition period) |
0/2 0/32 | 0 | 2 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9491 R33450 |
Endo (Phenobarbital) (Controls unexposed, disease free), 2004 | Congenital malformations | throughout pregnancy | retrospective cohort | unexposed, disease free excluded | Adjustment: No |
1.20 [0.07;21.20] C excluded (control group) |
0/10 27/656 | 27 | 10 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9492 R33465 |
Endo (Phenobarbital) (Controls unexposed, sick), 2004 | Congenital malformations | throughout pregnancy | retrospective cohort | unexposed, sick | Adjustment: No | 0.05 [0.00;6.68] C | 0/10 0/1 | 0 | 10 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9578 R33931 |
Kaaja (Phenobarbital or Primidone), 2003 | Major malformation | 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 11.85 [0.99;141.86] C | 1/11 2/239 | 3 | 11 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9571 R33908 |
Dean (Phenobarbital or Primidone), 2002 | Congenital malformations (major and minor) | at least 1st trimester | retrospective cohort | unexposed, sick | Adjustment: No | 3.78 [1.45;9.85] C | 29/63 7/38 | 36 | 63 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9497 R33486 |
Holmes (Phenobarbital) (Controls unexposed, disease free), 2001 | Major malformations | during pregnancy (anytime or not specified) | retrospective cohort | unexposed, disease free excluded | Adjustment: Yes |
2.70 [0.60;16.40] excluded (control group) |
3/64 9/508 | 12 | 64 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9498 R33495 |
Holmes (Phenobarbital) (Controls unexposed, sick), 2001 | Major malformations | during pregnancy (anytime or not specified) excluded | retrospective cohort | unexposed, sick | Adjustment: No |
11.28 [0.57;222.22] C excluded (exposition period) |
3/64 0/98 | 3 | 64 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9484 R33349 |
Al Bunyan (Phenobarbital), 1999 | Congenital malformations | during pregnancy (anytime or not specified) excluded | retrospective cohort | unexposed, sick | Adjustment: No |
6.33 [0.09;458.24] C excluded (exposition period) |
0/2 0/10 | 0 | 2 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9577 R33929 |
Canger (Phenobarbital or Primidone), 1999 | All type of malformation | 1st trimester | prospective cohort | unexposed, sick | Adjustment: No | 3.33 [0.18;60.20] C | 7/118 0/25 | 7 | 118 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9579 R33932 |
Kaneko (Phenobarbital or Primidone), 1999 | Malformations | throughout pregnancy | prospective cohort | unexposed, sick | Adjustment: No | 2.59 [0.68;9.85] C | 9/119 3/98 | 12 | 119 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9584 R33940 |
Samrén (Phenobarbital or Primidone), 1999 | Major congential abnormalities | at least 1st trimester | retrospective cohort | unexposed, disease free | Adjustment: No Matched | 1.78 [0.68;4.65] C | 5/196 29/2,000 | 34 | 196 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9585 R33942 |
Steegers-Theunissen (Phenobarbital or Primidone), 1994 | Major malformations (ICD9 British Paediatric Association System) | during pregnancy (anytime or not specified) excluded | prospective cohort | unexposed, disease free | Adjustment: No |
4.33 [0.37;51.42] C excluded (exposition period) |
1/13 2/106 | 3 | 13 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9488 R33364 |
D'Souza (Phenobarbital) (Controls unexposed, disease free), 1991 | Congenital anomalies | throughout pregnancy | prospective cohort | unexposed, disease free excluded | Adjustment: No Matched |
73.80 [2.36;2304.87] C excluded (control group) |
1/4 0/62 | 1 | 4 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9489 R33393 |
D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 | Congenital anomalies | throughout pregnancy | prospective cohort | unexposed, sick | Adjustment: No | 2.33 [0.11;50.99] C | 1/4 1/8 | 2 | 4 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9530 R33684 |
Robert (Phenobarbital), 1986 | Congenital malformations (minor and major) | 1st trimester | retrospective cohort | unexposed, sick | Adjustment: No | 1.37 [0.35;5.31] C | 6/40 4/35 | 10 | 40 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9522 R33618 |
Kelly (Phenobarbital), 1984 | Major abnormality | during pregnancy (anytime or not specified) excluded | prospective cohort | unexposed, sick | Adjustment: No |
0.52 [0.02;13.80] C excluded (exposition period) |
0/13 1/21 | 1 | 13 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9582 R33935 |
Lowe (Phenobarbital or Primidone) (Controls unexposed, disease free), 1973 | Malformations | 1st trimester | population based cohort retrospective | unexposed, disease free excluded | Adjustment: No |
0.64 [0.09;4.59] C excluded (control group) |
1/57 865/31,632 | 866 | 57 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9583 R33937 |
Lowe (Phenobarbital or Primidone) (Controls unexposed, sick), 1973 | Malformations | 1st trimester | population based cohort retrospective | unexposed, sick | Adjustment: No | 0.64 [0.07;6.32] C | 1/57 3/111 | 4 | 57 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Total | 17 studies | 2.33 [1.71;3.18] | 49,911 | 1,361 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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: Phenobarbital) (Controls unexposed, disease free) (Indications NOS; 2: Phenobarbital) (Controls unexposed, sick; 3: Phenobarbital or Primidone) (Controls unexposed, sick; 4: Phenobarbital or Primidone; 5: Phenobarbital) (Controls unexposed, sick) (Mixed indications; 6: Phenobarbital) (Controls unexposed, disease free) (Other indications; 7: Phenobarbital or Primidone) (Controls unexposed, NOS) (Indications NOS; 8: Phenobarbital or Primidone; 9: Phenobarbital) (Controls unexposed, sick; 10: Phenobarbital or Primidone; 11: Phenobarbital or Primidone; 12: Phenobarbital or Primidone; 13: Phenobarbital or Primidone; 14: Phenobarbital or Primidone; 15: Phenobarbital) (Controls unexposed, sick; 16: Phenobarbital; 17: Phenobarbital or Primidone) (Controls unexposed, sick;
Asymetry test p-value = 0.5879 (by Egger's regression)
slope=0.9890 (0.2891); intercept=-0.2720 (0.4911); t=0.5538; p=0.5879
excluded 9582, 9488, 9497, 9491, 9570, 9515, 9572, 9506, 9507, 9587, 12841, 12842, 16802