| 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| S16073 R66702 |
Christensen (Phenobarbital) (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: No |
1.60 [1.07;2.40] C excluded (control group) |
29/183 920/8,756 | 949 | 183 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S16043 R66589 |
Christensen (Phenobarbital) (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 | 1.46 [0.97;2.20] | 29/183 446,267/4,467,848 | 446,296 | 183 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9160 R31486 |
Coste (Phenobarbital) (Controls exposed to Lamotrigine, sick), 2020 | Small for gestational age (weight) | during pregnancy (anytime or not specified) | retrospective cohort (claims database) | exposed to other treatment, sick excluded | Adjustment: No Controls: mixed indications |
2.26 [1.31;3.90] C excluded (control group) |
17/84 284/2,813 | 301 | 84 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9161 R31504 |
Coste (Phenobarbital) (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 | 2.34 [1.37;3.98] C | 17/84 167,376/1,710,441 | 167,393 | 84 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9159 R31478 |
Hernández-Díaz (Phenobarbital), 2017 | Small for gestational age (<10th percentile) | throughout pregnancy | prospective cohort | exposed to other treatment, sick | Adjustment: Yes | 2.40 [1.60;3.60] | -/178 -/1,799 | - | 178 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9099 R31167 |
Burja (Phenobarbital) (Controls unexposed, disease free), 2006 | Small for date (NOS) | during pregnancy (anytime or not specified) | retrospective cohort (registry) | unexposed, disease free excluded | Adjustment: No |
7.98 [0.15;411.65] C excluded (control group) |
0/1 23/211 | 23 | 1 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9100 R31172 |
Burja (Phenobarbital) (Controls unexposed, sick), 2006 | Small for date (NOS) | during pregnancy (anytime or not specified) | retrospective cohort (registry) | unexposed, sick | Adjustment: No | 20.33 [0.29;1423.95] C | 0/1 1/32 | 1 | 1 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9104 R31252 |
Endo (Phenobarbital) (Controls unexposed, disease free), 2004 | Intrauterine growth retardation (NOS) | throughout pregnancy | retrospective cohort | unexposed, disease free excluded | Adjustment: No |
0.95 [0.05;16.63] C excluded (control group) |
0/10 34/656 | 34 | 10 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9105 R31267 |
Endo (Phenobarbital) (Controls unexposed, sick), 2004 | Intrauterine growth retardation (NOS) | throughout pregnancy | retrospective cohort | unexposed, sick | Adjustment: No | 0.05 [0.00;6.68] C | 0/10 0/1 | 0 | 10 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Total | 5 studies | 1.99 [1.35;2.93] | 613,690 | 456 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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) (All indications) (Controls unexposed, general population; 2: Phenobarbital) (Controls unexposed, NOS; 3: Phenobarbital; 4: Phenobarbital) (Controls unexposed, sick; 5: Phenobarbital) (Controls unexposed, sick;
Asymetry test p-value = 0.9115 (by Egger's regression)
slope=0.7105 (0.3322); intercept=-0.1393 (1.1530); t=0.1208; p=0.9115
excluded 9104, 9099, 9160, 16073