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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S9039 R30838 |
Aydin (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2020 | Preterm delivery (before 37 weeks of gestation) | throughout pregnancy | retrospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
1.86 [0.03;115.45] C excluded (control group) |
0/4 0/7 | 0 | 4 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9040 R30848 |
Aydin (Oxcarbazepine) (Controls unexposed, sick), 2020 | Preterm delivery (before 37 weeks of gestation) | throughout pregnancy | retrospective cohort | unexposed, sick | Adjustment: No | 1.11 [0.04;28.53] C | 0/4 2/22 | 2 | 4 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S10097 R36764 |
Coste (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2020 | Gestational age at birth (< 37 WA) | during pregnancy (anytime or not specified) | retrospective cohort (claims database) | exposed to other treatment, sick excluded | Adjustment: No Controls: mixed indications |
1.13 [0.58;2.19] C excluded (control group) |
10/143 182/2,916 | 192 | 143 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9087 R31110 |
Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020 | Gestational age at birth (< 37 WA) | during pregnancy (anytime or not specified) | retrospective cohort (claims database) | unexposed (general population or NOS) | Adjustment: No | 1.33 [0.70;2.54] C | 10/143 91,255/1,710,441 | 91,265 | 143 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9041 R30862 |
Cohen (Oxcarbazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2019 | Preterm birth (ICD-9 644.2, 774.2, 776.6, 362.20, 362.22, 362.27, 765 excluding 765.20, 765.29) | early pregnancy | retrospective cohort (claims database) | exposed to other treatment, sick excluded | Adjustment: Yes |
1.28 [1.06;1.55] excluded (control group) |
187/1,109 392/2,682 | 579 | 1,109 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9043 R30876 |
Cohen (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 | Preterm birth (ICD-9 644.2, 774.2, 776.6, 362.20, 362.22, 362.27, 765 excluding 765.20, 765.29) | early pregnancy | retrospective cohort (claims database) | unexposed (general population or NOS) | Adjustment: Yes | 1.09 [0.95;1.25] | 187/1,109 160,604/1,440,631 | 160,791 | 1,109 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9042 R30865 |
Bank (Oxcarbazepine) (Mixed indications), 2017 | Premature (<37 weeks gestation) | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick | Adjustment: No | 3.29 [0.11;96.92] C | 0/4 1/36 | 1 | 4 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9093 R31153 |
Kilic (Oxcarbazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 | Preterm (< 37 weeks) | during pregnancy (anytime or not specified) | population based cohort retrospective | exposed to other treatment, sick excluded | Adjustment: No |
0.66 [0.40;1.10] C excluded (control group) |
20/310 83/880 | 103 | 310 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9094 R31156 |
Kilic (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2014 | Preterm (< 37 weeks) | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed (general population or NOS) excluded | Adjustment: No |
1.30 [0.80;2.00] excluded (control group) |
20/310 33,974/676,834 | 33,994 | 310 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9095 R31159 |
Kilic (Oxcarbazepine) (Controls unexposed, sick) (Mixed indications), 2014 | Preterm (< 37 weeks) | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed, sick | Adjustment: No Controls: epilepsy indication | 0.88 [0.56;1.41] C | 20/310 383/5,296 | 403 | 310 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9036 R30809 |
Artama (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2013 | Preterm birth (<37 gestational weeks) | during pregnancy (anytime or not specified) | population based cohort retrospective | exposed to other treatment, sick excluded | Adjustment: No |
0.94 [0.41;2.14] C excluded (control group) |
23/527 8/173 | 31 | 527 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9037 R30821 |
Artama (Oxcarbazepine) (Controls unexposed, disease free), 2013 | Preterm birth (<37 gestational weeks) | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed, disease free excluded | Adjustment: Yes |
1.00 [0.66;1.52] excluded (control group) |
23/527 30,027/719,509 | 30,050 | 527 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
S9038 R30833 |
Artama (Oxcarbazepine) (Controls unexposed, sick), 2013 | Preterm birth (<37 gestational weeks) | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed, sick | Adjustment: Yes | 0.89 [0.55;1.44] | 23/527 85/1,793 | 108 | 527 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Total | 6 studies | 1.07 [0.94;1.21] | 252,570 | 2,097 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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) (Controls unexposed, sick; 2: Oxcarbazepine) (Controls unexposed, NOS; 3: Oxcarbazepine) (Controls unexposed NOS) (Mixed indications; 4: Oxcarbazepine) (Mixed indications; 5: Oxcarbazepine) (Controls unexposed, sick) (Mixed indications; 6: Oxcarbazepine) (Controls unexposed, sick;
Asymetry test p-value = 0.9521 (by Egger's regression)
slope=0.0639 (0.0646); intercept=0.0266 (0.4158); t=0.0640; p=0.9521
excluded 9036, 9037, 9093, 9094, 9041, 9039, 10097