| 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| S12541 R47231 |
Dreier (Oxcarbazepine), 2021 | Small for gestational age (birth weight below the 10th percentile for GA, sex and country) | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed, sick | Adjustment: Yes | 1.37 [1.13;1.65] | -/1,459 -/- | - | 1,459 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9039 R30840 |
Aydin (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2020 | Small for gestational age (birth weight) | throughout pregnancy | retrospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
7.80 [0.23;262.83] C excluded (control group) |
1/4 0/7 | 1 | 4 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9040 R30850 |
Aydin (Oxcarbazepine) (Controls unexposed, sick), 2020 | Small for gestational age (birth weight) | throughout pregnancy | retrospective cohort | unexposed, sick | Adjustment: No | 25.80 [0.81;819.45] C | 1/4 0/22 | 1 | 4 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9087 R31113 |
Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020 | Small for gestational age (weight) | during pregnancy (anytime or not specified) | retrospective cohort (claims database) | unexposed (general population or NOS) | Adjustment: No | 1.00 [0.58;1.74] C | 14/143 167,376/1,710,441 | 167,390 | 143 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9041 R30861 |
Cohen (Oxcarbazepine) (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 |
1.43 [0.99;2.07] excluded (control group) |
47/1,109 106/2,682 | 153 | 1,109 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9043 R30875 |
Cohen (Oxcarbazepine) (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 | 0.95 [0.70;1.27] | 47/1,109 41,653/1,440,631 | 41,700 | 1,109 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9042 R30866 |
Bank (Oxcarbazepine) (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 | 3.67 [0.29;47.11] C | 1/4 3/36 | 4 | 4 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9093 R31152 |
Kilic (Oxcarbazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 | Small for gestational age (birth weight <10% percentile for the gestational birth week) | during pregnancy (anytime or not specified) | population based cohort retrospective | exposed to other treatment, sick excluded | Adjustment: No |
1.94 [1.32;2.85] C excluded (control group) |
49/307 78/876 | 127 | 307 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9094 R31155 |
Kilic (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2014 | Small for gestational age (birth weight <10% percentile for the gestational birth week) | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed (general population or NOS) excluded | Adjustment: Yes |
1.50 [1.10;2.00] excluded (control group) |
49/310 65,118/673,844 | 65,167 | 310 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9095 R31158 |
Kilic (Oxcarbazepine) (Controls unexposed, sick) (Mixed indications), 2014 | Small for gestational age (birth weight <10% percentile for the gestational birth week) | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed, sick | Adjustment: No Controls: epilepsy indication | 1.50 [1.09;2.06] C | 49/307 594/5,275 | 643 | 307 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9036 R30811 |
Artama (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2013 | Small for gestational age (weight) | during pregnancy (anytime or not specified) | population based cohort retrospective | exposed to other treatment, sick excluded | Adjustment: No |
3.02 [0.69;13.17] C excluded (control group) |
18/527 2/173 | 20 | 527 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9037 R30823 |
Artama (Oxcarbazepine) (Controls unexposed, disease free), 2013 | Small for gestational age (weight) | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed, disease free excluded | Adjustment: Yes |
1.64 [1.02;2.64] excluded (control group) |
18/527 14,079/719,509 | 14,097 | 527 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9038 R30835 |
Artama (Oxcarbazepine) (Controls unexposed, sick), 2013 | Small for gestational age (weight) | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed, sick | Adjustment: Yes | 1.52 [0.91;2.53] | 18/527 42/1,793 | 60 | 527 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Total | 7 studies | 1.28 [1.04;1.58] | 209,798 | 3,553 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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: Oxcarbazepine; 2: Oxcarbazepine) (Controls unexposed, sick; 3: Oxcarbazepine) (Controls unexposed, NOS; 4: Oxcarbazepine) (Controls unexposed NOS) (Mixed indications; 5: Oxcarbazepine) (Mixed indications; 6: Oxcarbazepine) (Controls unexposed, sick) (Mixed indications; 7: Oxcarbazepine) (Controls unexposed, sick;
Asymetry test p-value = 0.4093 (by Egger's regression)
slope=0.1394 (0.1546); intercept=0.7748 (0.8607); t=0.9002; p=0.4093
excluded 9036, 9037, 9093, 9094, 9041, 9039