| 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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| S16066 R66674 |
Christensen (Carbamazepine) (All indications) (Controls exposed to LTG), 2024 | Small for gestational age (a z-score for birth weight ≤10th percentile for gestational week, sex, and country (including newborns with congenital malformations)) | during pregnancy (anytime or not specified) | population based cohort retrospective | exposed to other treatment, sick excluded | Adjustment: Yes |
1.37 [1.17;1.60] excluded (control group) |
428/3,424 920/8,756 | 1,348 | 3,424 |
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| S16019 R66499 |
Christensen (Carbamazepine) (All indications) (Controls unexposed, general population), 2024 | Small for gestational age (a z-score for birth weight ≤10th percentile for gestational week, sex, and country (including newborns with congenital malformations)) | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed (general population or NOS) | Adjustment: Yes | 1.25 [1.12;1.40] | 428/3,424 446,267/4,467,848 | 446,695 | 3,424 |
|
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| S15367 R63235 |
Bromley (Carbamazepine) (Epilepsy) (Controls exposed to LTG), 2023 | Small for gestation (calculated using gender-specific scales) | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
0.28 [0.03;2.20] C excluded (control group) |
1/27 13/106 | 14 | 27 |
|
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| S15368 R63248 |
Bromley (Carbamazepine) (Epilepsy) (Controls unexposed, sick), 2023 | Small for gestation (calculated using gender-specific scales) | during pregnancy (anytime or not specified) | prospective cohort | unexposed, sick | Adjustment: No | 0.20 [0.02;1.59] C | 1/27 13/80 | 14 | 27 |
|
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| S9602 R34030 |
Aydin (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2020 | Small for gestational age (birth weight) | throughout pregnancy | retrospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
2.60 [0.11;62.58] C excluded (control group) |
2/15 0/7 | 2 | 15 |
|
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| S9603 R34040 |
Aydin (Carbamazepine) (Controls unexposed, sick), 2020 | Small for gestational age (birth weight) | throughout pregnancy | retrospective cohort | unexposed, sick | Adjustment: No | 8.60 [0.38;193.87] C | 2/15 0/22 | 2 | 15 |
|
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| S9777 R34978 |
Coste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 2020 | Small for gestational age (weight) | during pregnancy (anytime or not specified) | retrospective cohort (claims database) | unexposed (general population or NOS) | Adjustment: No | 1.05 [0.78;1.42] C | 48/468 167,016/1,707,707 | 167,064 | 468 |
|
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| S9761 R34852 |
Cohen (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2019 | Small for gestational age (ICD-9 656.5, 764.0, 764.1, 764.9) | early pregnancy | retrospective cohort (claims database) | exposed to other treatment, sick excluded | Adjustment: Yes |
1.16 [0.59;2.26] excluded (control group) |
55/1,232 106/2,682 | 161 | 1,232 |
|
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| S9762 R34859 |
Cohen (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019 | Small for gestational age (ICD-9 656.5, 764.0, 764.1, 764.9) | early pregnancy | retrospective cohort (claims database) | unexposed (general population or NOS) | Adjustment: Yes | 0.97 [0.68;1.39] | 55/1,232 41,653/1,440,631 | 41,708 | 1,232 |
|
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| S18016 R75957 |
Margulis (Carbamazepine) (Mixed indications), 2019 | Small for gestational age (defined within the Medical Birth Register from standard growth curves based on ultra- sound-derived fetal weights for singletons only) | during pregnancy (anytime or not specified) | population based cohort retrospective | exposed to other treatment, sick | Adjustment: Yes | 1.30 [0.80;2.00] | -/1,821 -/1,808 | - | 1,821 |
|
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| S9760 R34843 |
Bank (Carbamazepine) (Mixed indications), 2017 | Small for Gestational Age birthweight (<10th percentile) | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick | Adjustment: No | 1.57 [0.14;17.42] C | 1/8 3/36 | 4 | 8 |
|
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| S9743 R34762 |
Veiby (Carbamazepine) (Controls exposed to Lamotrigine, sick) b, 2013 | Small for gestational age (SGA) birth weight | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
3.04 [0.97;9.51] C excluded (control group) |
9/67 5/103 | 14 | 67 |
|
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| S9745 R34781 |
Veiby (Carbamazepine) (Controls unexposed, disease free) b, 2013 | Small for gestational age (SGA) birth weight | during pregnancy (anytime or not specified) | prospective cohort | unexposed, disease free excluded | Adjustment: Yes |
2.40 [1.20;4.90] excluded (control group) |
9/67 8,017/106,899 | 8,026 | 67 |
|
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| S9746 R34795 |
Veiby (Carbamazepine) (Controls unexposed, sick) b, 2013 | Small for gestational age (SGA) birth weight | during pregnancy (anytime or not specified) | prospective cohort | unexposed, sick | Adjustment: No | 1.78 [0.80;3.92] C | 9/67 31/386 | 40 | 67 |
|
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| S9640 R34292 |
Pennell (Carbamazepine), 2012 | Small for gestational age (SGA) (at birth) | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick | Adjustment: Yes | 3.14 [0.91;10.90] | 12/93 4/98 | 16 | 93 |
|
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| S9606 R34056 |
Burja (Carbamazepine) (Controls unexposed, disease free), 2006 | Small for date (NOS) | during pregnancy (anytime or not specified) | retrospective cohort (registry) | unexposed, disease free excluded | Adjustment: No |
1.53 [0.41;5.66] C excluded (control group) |
3/19 23/211 | 26 | 19 |
|
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| S9607 R34061 |
Burja (Carbamazepine) (Controls unexposed, sick), 2006 | Small for date (NOS) | during pregnancy (anytime or not specified) | retrospective cohort (registry) | unexposed, sick | Adjustment: No | 5.81 [0.56;60.48] C | 3/19 1/32 | 4 | 19 |
|
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| S9615 R34161 |
Endo (Carbamazepine) (Controls unexposed, disease free), 2004 | Intrauterine growth retardation (NOS) | throughout pregnancy | retrospective cohort | unexposed, disease free excluded | Adjustment: No |
2.61 [0.31;21.85] C excluded (control group) |
1/8 34/656 | 35 | 8 |
|
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| S9616 R34176 |
Endo (Carbamazepine) (Controls unexposed, sick), 2004 | Intrauterine growth retardation (NOS) | throughout pregnancy | retrospective cohort | unexposed, sick | Adjustment: No | 0.23 [0.00;17.06] C | 1/8 0/1 | 1 | 8 |
|
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| S9651 R34339 |
Wide (Carbamazepine), 2000 | Small for gestationnal age | throughout pregnancy | prospective cohort | unexposed (general population or NOS) | Adjustment: No Matched | 0.95 [0.02;49.04] C | 0/39 0/37 | 0 | 39 |
|
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| Total | 12 studies | 1.20 [1.03;1.40] | 655,548 | 7,221 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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: Carbamazepine) (All indications) (Controls unexposed, general population; 2: Carbamazepine) (Epilepsy) (Controls unexposed, sick; 3: Carbamazepine) (Controls unexposed, sick; 4: Carbamazepine) (Controls unexposed, NOS) (Mixed indications; 5: Carbamazepine) (Controls unexposed NOS) (Mixed indications; 6: Carbamazepine) (Mixed indications; 7: Carbamazepine) (Mixed indications; 8: Carbamazepine) (Controls unexposed, sick) ; 9: Carbamazepine; 10: Carbamazepine) (Controls unexposed, sick; 11: Carbamazepine) (Controls unexposed, sick; 12: Carbamazepine;
Asymetry test p-value = 0.7445 (by Egger's regression)
slope=0.1854 (0.0688); intercept=0.1350 (0.4028); t=0.3351; p=0.7445
excluded 9615, 9606, 9743, 9745, 9761, 9602, 15367, 16066