| 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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| S15367 R63234 |
Bromley (Carbamazepine) (Epilepsy) (Controls exposed to LTG), 2023 | Preterm birth (gestational age < 37 weeks) | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
0.76 [0.20;2.84] C excluded (control group) |
3/27 15/106 | 18 | 27 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S15368 R63247 |
Bromley (Carbamazepine) (Epilepsy) (Controls unexposed, sick), 2023 | Preterm birth (gestational age < 37 weeks) | during pregnancy (anytime or not specified) | prospective cohort | unexposed, sick | Adjustment: No | 0.78 [0.20;3.05] C | 3/27 11/80 | 14 | 27 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9602 R34028 |
Aydin (Carbamazepine) (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 |
2.60 [0.11;62.58] C excluded (control group) |
2/15 0/7 | 2 | 15 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9603 R34038 |
Aydin (Carbamazepine) (Controls unexposed, sick), 2020 | Preterm delivery (before 37 weeks of gestation) | throughout pregnancy | retrospective cohort | unexposed, sick | Adjustment: No | 1.54 [0.19;12.32] C | 2/15 2/22 | 4 | 15 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9776 R34957 |
Coste (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 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 |
0.79 [0.51;1.21] C excluded (control group) |
25/502 182/2,916 | 207 | 502 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9777 R34975 |
Coste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 2020 | Gestational age at birth (< 37 WA) | during pregnancy (anytime or not specified) | retrospective cohort (claims database) | unexposed (general population or NOS) | Adjustment: No | 0.88 [0.57;1.34] C | 22/468 90,991/1,707,707 | 91,013 | 468 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9761 R34853 |
Cohen (Carbamazepine) (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 |
1.16 [0.88;1.52] excluded (control group) |
186/1,232 392/2,682 | 578 | 1,232 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9762 R34860 |
Cohen (Carbamazepine) (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 | 0.90 [0.75;1.09] | 186/1,232 160,604/1,440,631 | 160,790 | 1,232 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9760 R34842 |
Bank (Carbamazepine) (Mixed indications), 2017 | Premature (<37 weeks gestation) | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick | Adjustment: No | 11.67 [0.91;149.71] C | 2/8 1/36 | 3 | 8 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9597 R33985 |
Arkilo (Carbamazepine), 2015 | Premature delivery | during pregnancy (anytime or not specified) | retrospective cohort | exposed to other treatment, sick | Adjustment: No | 3.52 [0.68;18.07] C | 5/14 3/22 | 8 | 14 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9772 R34945 |
Kilic (Carbamazepine) (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 |
0.84 [0.54;1.32] C excluded (control group) |
28/347 83/880 | 111 | 347 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9773 R34948 |
Kilic (Carbamazepine) (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: Yes |
1.60 [1.00;2.30] excluded (control group) |
28/347 33,974/676,834 | 34,002 | 347 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9774 R34951 |
Kilic (Carbamazepine) (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 | 1.13 [0.75;1.68] C | 28/347 383/5,296 | 411 | 347 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9598 R33998 |
Artama (Carbamazepine) (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 |
1.17 [0.55;2.50] C excluded (control group) |
58/1,077 8/173 | 66 | 1,077 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9599 R34010 |
Artama (Carbamazepine) (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 |
1.32 [1.01;1.72] excluded (control group) |
58/1,077 30,027/719,509 | 30,085 | 1,077 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9600 R34022 |
Artama (Carbamazepine) (Controls unexposed, sick), 2013 | Preterm birth (<37 gestational weeks) | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed, sick | Adjustment: Yes | 1.13 [0.80;1.60] | 58/1,077 85/1,793 | 143 | 1,077 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9743 R34760 |
Veiby (Carbamazepine) (Controls exposed to Lamotrigine, sick) b, 2013 | Preterm delivery (< 37 weeks) | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
0.87 [0.24;3.10] C excluded (control group) |
4/67 7/103 | 11 | 67 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9745 R34779 |
Veiby (Carbamazepine) (Controls unexposed, disease free) b, 2013 | Preterm delivery (< 37 weeks) | during pregnancy (anytime or not specified) | prospective cohort | unexposed, disease free excluded | Adjustment: No |
0.80 [0.30;2.30] excluded (control group) |
4/67 7,269/106,899 | 7,273 | 67 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9746 R34793 |
Veiby (Carbamazepine) (Controls unexposed, sick) b, 2013 | Preterm delivery (< 37 weeks) | during pregnancy (anytime or not specified) | prospective cohort | unexposed, sick | Adjustment: No | 0.75 [0.26;2.21] C | 4/67 30/386 | 34 | 67 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9640 R34293 |
Pennell (Carbamazepine), 2012 | Preterm Birth (< 37 weeks GA) | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick | Adjustment: No | 1.85 [0.64;5.30] C | 10/93 6/98 | 16 | 93 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9712 R34568 |
Cummings (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2011 | Preterm (35-37 weeks) | throughout pregnancy | retrospective cohort (registry) | exposed to other treatment, sick excluded | Adjustment: No |
0.53 [0.13;2.15] C excluded (control group) |
4/49 5/35 | 9 | 49 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9713 R34571 |
Cummings (Carbamazepine) (Controls unexposed, disease free), 2011 | Preterm (35-37 weeks) | throughout pregnancy | retrospective cohort (registry) | unexposed, disease free | Adjustment: No | 8.80 [0.46;168.35] C | 4/49 0/44 | 4 | 49 |
|
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| S9733 R34663 |
Nadebaum (Carbamazepine), 2011 | Born premature (<37 wk) | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick | Adjustment: No | 0.78 [0.03;21.03] C | 1/34 0/9 | 1 | 34 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9729 R34644 |
McVearry (Carbamazepine), 2009 | Premature birth | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick | Adjustment: No | 6.11 [0.27;138.46] C | 2/16 0/17 | 2 | 16 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9615 R34169 |
Endo (Carbamazepine) (Controls unexposed, disease free), 2004 | Preterm delivery (< week 37) | throughout pregnancy | retrospective cohort | unexposed, disease free excluded | Adjustment: No |
2.12 [0.41;11.09] C excluded (control group) |
2/7 104/656 | 106 | 7 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9616 R34184 |
Endo (Carbamazepine) (Controls unexposed, sick), 2004 | Preterm delivery (< week 37) | throughout pregnancy | retrospective cohort | unexposed, sick | Adjustment: No | 0.56 [0.01;37.57] C | 2/7 0/1 | 2 | 7 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9662 R34401 |
Diav-Citrin (Carbamazepine), 2001 | Premature infants (week < 37) | at least 1st trimester | prospective cohort | unexposed (general population or NOS) | Adjustment: No Matched | 2.41 [0.90;6.48] C | 9/91 8/184 | 17 | 91 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9740 R34706 |
Van der Pol (Carbamazepine) (Controls unexposed, disease free), 1991 | Gestational age (≤ 37 wk) | throughout pregnancy | prospective cohort | unexposed, disease free excluded | Adjustment: No Matched |
0.53 [0.03;10.70] C excluded (control group) |
0/11 4/55 | 4 | 11 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9741 R34731 |
Van der Pol (Carbamazepine) (Controls unexposed, sick), 1991 | Gestational age (≤ 37 wk) | throughout pregnancy | prospective cohort | unexposed, sick | Adjustment: No | 0.37 [0.02;8.48] C | 0/11 2/22 | 2 | 11 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Total | 16 studies | 1.06 [0.88;1.27] | 252,464 | 3,556 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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) (Epilepsy) (Controls unexposed, sick; 2: Carbamazepine) (Controls unexposed, sick; 3: Carbamazepine) (Controls unexposed, NOS) (Mixed indications; 4: Carbamazepine) (Controls unexposed NOS) (Mixed indications; 5: Carbamazepine) (Mixed indications; 6: Carbamazepine; 7: Carbamazepine) (Controls unexposed, sick) (Mixed indications; 8: Carbamazepine) (Controls unexposed, sick; 9: Carbamazepine) (Controls unexposed, sick) ; 10: Carbamazepine; 11: Carbamazepine) (Controls unexposed, disease free; 12: Carbamazepine; 13: Carbamazepine; 14: Carbamazepine) (Controls unexposed, sick; 15: Carbamazepine; 16: Carbamazepine) (Controls unexposed, sick;
Asymetry test p-value = 0.0273 (by Egger's regression)
slope=-0.1390 (0.0873); intercept=0.7686 (0.3119); t=2.4645; p=0.0273
excluded 9740, 9615, 9712, 9598, 9599, 9743, 9745, 9772, 9773, 9761, 9602, 9776, 15367