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Lamotrigine Pregnancy Registry (LAM05)

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ClinicalTrials.gov Identifier: NCT01064297
Recruitment Status : Completed
First Posted : February 8, 2010
Results First Posted : October 11, 2010
Last Update Posted : February 25, 2013
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Epilepsy
Bipolar Disorder
Interventions Drug: Lamotrigine monotherapy
Drug: Lamotrigine polytherapy including valproate
Drug: Lamotrigine polytherapy without valproate
Enrollment 3416
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lamotrigine Monotherapy Pregnancy Exposures Lamotrigine Polytherapy With Valproate Pregnancy Exposures Lamotrigine Polytherapy Without Valproate Pregnancy Exposures
Hide Arm/Group Description Prospectively enrolled pregnancies exposed to lamotrigine monotherapy at doses between 0-1200 mg/day Prospectively enrolled pregnancies exposed to lamotrigine polytherapy with valproate, all dose ranges Prospectively enrolled pregnancies exposed to lamotrigine polytherapy without valproate, all dose ranges
Period Title: Overall Study
Started 2567 219 630
Completed 1776 171 497
Not Completed 791 48 133
Reason Not Completed
Lost to Follow-up             791             48             133
Arm/Group Title Lamotrigine Monotherapy Pregnancy Exposures Lamotrigine Polytherapy With Valproate Pregnancy Exposures Lamotrigine Polytherapy Without Valproate Pregnancy Exposures Total
Hide Arm/Group Description Prospectively enrolled pregnancies exposed to lamotrigine monotherapy at doses between 0-1200 mg/day Prospectively enrolled pregnancies exposed to lamotrigine polytherapy with valproate, all dose ranges Prospectively enrolled pregnancies exposed to lamotrigine polytherapy without valproate, all dose ranges Total of all reporting groups
Overall Number of Baseline Participants 2567 219 630 3416
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2567 participants 219 participants 630 participants 3416 participants
27.9  (5.84) 25.8  (5.49) 28.1  (6.08) 27.8  (5.89)
[1]
Measure Description: Prospectively enrolled pregnancies with pregnancy outcome known or lost to follow-up.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2567 participants 219 participants 630 participants 3416 participants
Female
2567
 100.0%
219
 100.0%
630
 100.0%
3416
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: Prospectively enrolled pregnancies with pregnancy outcome known or lost to follow-up.
1.Primary Outcome
Title Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy
Hide Description The number of live births, fetal deaths, induced abortions, and spontaneous pregnancy losses were recorded according to the time at which women were first exposed to lamotrigine monotherapy. Due to inconsistent identification of major congenital malformations (MCMs) among spontaneous losses, no comment is made concerning the presence or absence of MCMs.
Time Frame Although reports and diagnoses of major congenital malformations are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth
Hide Outcome Measure Data
Hide Analysis Population Description
Prospectively enrolled pregnancies exposed to lamotrigine monotherapy.
Arm/Group Title First Exposure During First Trimester First Exposure During Second Trimester First Exposure During Third Trimester Unspecified Trimester of Exposure
Hide Arm/Group Description:
The first trimester begins at conception
The second trimester begins at 14 weeks gestation
The third trimester begins at 28 weeks gestation
The earliest trimester of exposure was not specified
Overall Number of Participants Analyzed 1699 95 18 5
Measure Type: Number
Unit of Measure: infants
Live Birth (Birth Defects Reported) 31 4 1 0
Fetal Death (Birth Defects Reported) 1 0 0 0
Induced Abortion (Birth Defects Reported) 3 0 0 0
Live Birth (No Birth Defects Reported) 1523 91 17 5
Fetal Death (No Birth Defects Reported) 10 0 0 0
Induced Abortion (No Birth Defects Reported) 33 0 0 0
Spontaneous Pregnancy Loss 98 0 0 0
2.Primary Outcome
Title Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy With Valproate
Hide Description The number of live births, fetal deaths, induced abortions, and spontaneous pregnancy losses were recorded according to the time at which women were first exposed to lamotrigine polytherapy with valproate. Due to inconsistent identification of major congenital malformations (MCMs) among spontaneous losses, no comment is made concerning the presence or absence of MCMs.
Time Frame Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported following assessments made in the delivery room or shortly after birth
Hide Outcome Measure Data
Hide Analysis Population Description
Prospectively enrolled pregnancies exposed to lamotrigine polytherapy with valproate.
Arm/Group Title First Exposure During First Trimester First Exposure During Second Trimester First Exposure During Third Trimester Unspecified Trimester of Exposure
Hide Arm/Group Description:
The first trimester begins at conception
The second trimester begins at 14 weeks gestation
The third trimester begins at 28 weeks gestation
The earliest trimester of exposure was not specified
Overall Number of Participants Analyzed 161 8 3 1
Measure Type: Number
Unit of Measure: infants
Live Birth (Birth Defects Reported) 14 1 0 0
Fetal Death (Birth Defects Reported) 0 0 0 0
Induced Abortion (Birth Defects Reported) 2 0 0 0
Live Birth (No Birth Defects Reported) 134 6 3 1
Fetal Death (No Birth Defects Reported) 1 1 0 0
Induced Abortion (No Birth Defects Reported) 4 0 0 0
Spontaneous Pregnancy Loss 6 0 0 0
3.Primary Outcome
Title Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy Without Valproate
Hide Description The number of live births, fetal deaths with pregnancy loss occurring >=20 weeks gestation, induced abortions, and spontaneous pregnancy losses were recorded according to the time at which women were first exposed to lamotrigine polytherapy without valproate. Due to inconsistent identification of major congenital malformations (MCMs) among spontaneous losses, no comment is made concerning the presence or absence of MCMs. Although birth defects may not have been reported, they cannot be ruled out.
Time Frame Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported following assessments made in the delivery room or shortly after birth
Hide Outcome Measure Data
Hide Analysis Population Description
Prospectively enrolled pregnancies exposed to the lamotrigine polytherapy without valproate
Arm/Group Title First Exposure During First Trimester First Exposure During Second Trimester First Exposure During Third Trimester Unspecified Trimester of Exposure
Hide Arm/Group Description:
The first trimester begins at conception
The second trimester begins at 14 weeks gestation
The third trimester begins at 28 weeks gestation
The earliest trimester of exposure was not specified
Overall Number of Participants Analyzed 474 25 3 0
Measure Type: Number
Unit of Measure: infants
Live Birth (Birth Defects Reported) 11 0 1
Fetal Death (Birth Defects Reported) 0 0 0
Induced Abortion (Birth Defects Reported) 1 0 0
Live Birth (No Birth Defects Reported) 418 25 2
Fetal Death (No Birth Defects Reported) 3 0 0
Induced Abortion (No Birth Defects Reported) 19 0 0
Spontaneous Pregnancy Loss 22 0 0
4.Primary Outcome
Title Number of Infants With Major Congenital Malformations by Earliest Trimester of Exposure to Lamotrigine Monotherapy
Hide Description Among lamotrigine monotherapy exposures: live births, fetal deaths, induced abortions with birth defects, and live births without defects. Due to the likelihood of inconsistent identification of birth defects among spontaneous losses, fetal deaths, and induced abortions without reported birth defects, these offspring were not included in analyses.
Time Frame Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth
Hide Outcome Measure Data
Hide Analysis Population Description
Among lamotrigine monotherapy exposures: live births, fetal deaths, induced abortions with birth defects, and live births without defects. Due to the likelihood of inconsistent identification of birth defects among spontaneous losses, fetal deaths, and induced abortions without reported birth defects, these offspring were not included in analyses.
Arm/Group Title First Exposure During First Trimester First Exposure During Second Trimester First Exposure During Third Trimester Unspecified Trimester of Exposure All Trimesters
Hide Arm/Group Description:
The first trimester begins at conception
The second trimester begins at 14 weeks gestation
The third trimester begins at 28 weeks gestation
The earliest trimester of exposure was not specified
Exposure during any trimester of pregnancy
Overall Number of Participants Analyzed 1558 95 18 5 1676
Measure Type: Number
Unit of Measure: infants
35 4 1 0 40
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection First Exposure During First Trimester
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Wilson Score with Continuity Correction
Estimated Value 2.2
Confidence Interval 95%
1.6 to 3.1
Estimation Comments The percentage of infants with MBDs was calculated as: the number of outcomes with MBDs divided by (the number of outcomes with MBDs + the number of live births without defects).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection First Exposure During Second Trimester
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Wilson Score with Continuity Correction
Estimated Value 4.2
Confidence Interval 95%
1.4 to 11.0
Estimation Comments The percentage of infants with MBDs was calculated as: the number of outcomes with MBDs divided by (the number of outcomes with MBDs + the number of live births without defects).
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection All Trimesters
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Wilson Score with Continuity Correction
Estimated Value 2.4
Confidence Interval 95%
1.7 to 3.3
Estimation Comments The percentage of infants with MBDs was calculated as: the number of outcomes with MBDs divided by (the number of outcomes with MBDs + the number of live births without defects).
5.Primary Outcome
Title Number of Infants With Major Congenital Malformations (MCMs) by Earliest Trimester of Exposure to Lamotrigine Polytherapy With Valproate
Hide Description The number of infants with major congenital malformations were counted and are presented by earliest trimester of exposure to lamotrigine polytherapy with valproate.
Time Frame Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported following assessments made in the delivery room or shortly after birth
Hide Outcome Measure Data
Hide Analysis Population Description
Among lamotrigine polytherapy with valproate exposures: live births, fetal deaths, induced abortions with defects, and live births without defects. Due to the likelihood of inconsistent identification of defects among spontaneous losses, fetal deaths, and induced abortions without reported defects, these offspring were not included in analyses.
Arm/Group Title First Exposure During First Trimester First Exposure During Second Trimester First Exposure During Third Trimester Unspecified Trimester of Exposure All Trimesters
Hide Arm/Group Description:
The first trimester begins at conception
The second trimester begins at 14 weeks gestation
The third trimester begins at 28 weeks gestation
The earliest trimester of exposure was not specified
Exposure during any trimester of pregnancy
Overall Number of Participants Analyzed 150 7 3 1 161
Measure Type: Number
Unit of Measure: infants
14 1 0 0 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection First Exposure During First Trimester
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Wilson Score with Continuity Correction
Estimated Value 10.7
Confidence Interval 95%
6.4 to 17.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection All Trimesters
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Wilson Score with Continuity Correction
Estimated Value 9.3
Confidence Interval 95%
5.5 to 15.2
Estimation Comments The percentage of infants with MBDs was calculated as: the number of outcomes with MBDs divided by (the number of outcomes with MBDs + the number of live births without defects).
6.Primary Outcome
Title Number of Infants With Major Congenital Malformations (MCMs) by Earliest Trimester of Exposure to Lamotrigine Polytherapy Without Valproate
Hide Description The number of infants with major congenital malformations were counted and are presented by earliest trimester of exposure to lamotrigine polytherapy without valproate.
Time Frame Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported following assessments made in the delivery room or shortly after birth
Hide Outcome Measure Data
Hide Analysis Population Description
Among lamotrigine polytherapy without valproate exposures: live births, fetal deaths, induced abortions with defects, and live births without defects. Due to the likelihood of inconsistent identification of defects among spontaneous losses, fetal deaths, and induced abortions without reported defects, these offspring were not included in analyses.
Arm/Group Title First Exposure During First Trimester First Exposure During Second Trimester First Exposure During Third Trimester Unspecified Trimester of Exposure All Trimesters
Hide Arm/Group Description:
The first trimester begins at conception
The second trimester begins at 14 weeks gestation
The third trimester begins at 28 weeks gestation
The earliest trimester of exposure was not specified
Exposure during any trimester of pregnancy
Overall Number of Participants Analyzed 430 25 3 0 458
Measure Type: Number
Unit of Measure: infants
12 0 1 13
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection First Exposure During First Trimester
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Wilson Score with Continuity Correction
Estimated Value 2.8
Confidence Interval 95%
1.5 to 5.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection All Trimesters
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Wilson Score with Continuity Correction
Estimated Value 2.8
Confidence Interval 95%
1.6 to 4.9
Estimation Comments The percentage of infants with MBDs was calculated as: the number of outcomes with MBDs divided by (the number of outcomes with MBDs + the number of live births without defects).
7.Primary Outcome
Title Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received
Hide Description The number of infants with the reported MCM following first trimester lamotrigine monotherapy exposure were counted. Registry personnel contacted the enrolling physician to obtain information on the pregnancy outcome, lamotrigine dosing and duration of exposure, and use of concomitant antiepileptic drugs during pregnancy.
Time Frame Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth
Hide Outcome Measure Data
Hide Analysis Population Description
Among lamotrigine monotherapy exposures in the first trimester: live births, fetal deaths, induced abortions with defects, and live births without defects. Due to the likely inconsistent identification of defects among spontaneous losses, fetal deaths, and induced abortions without reported defects, these offspring were not included in analyses.
Arm/Group Title Doses Lower Than Prescribed Prescribed Doses Dose Higher Than Prescribed Unknown Maximal Dose in Exposed Trimester
Hide Arm/Group Description:
>0 to 200 mg/day maximal dose in first trimester
201-400 mg/day maximal dose in first trimester
>400 mg/day maximal dose in first trimester
[Not Specified]
Overall Number of Participants Analyzed 15 12 6 2
Measure Type: Number
Unit of Measure: infants
Anencephaly 2 0 1 0
Orofacial clefts 2 0 0 0
Hypoplastic left heart/left ventricle hypoplasia 1 0 1 0
Transposition of great vessels 2 0 0 0
Ventricular septal defects 0 3 0 0
Minor heart defect, unspecified 0 1 0 0
Pulmonary stenosis 0 1 0 0
Hydronephrosis 1 1 0 0
Renal defect (absent, polysystic, fluid on kidney) 1 0 2 0
Cortical dysplasis 0 1 0 0
Hypospadias 1 1 0 0
Pyloric stenosis 0 1 0 1
Diaphragmatic hernia 1 0 1 0
Congenital atresia of anus 1 0 0 0
Hip dislocation 1 0 0 0
Club feet 0 1 1 1
Polydactyly 1 1 0 0
Epidermolysis bullosa 1 0 0 0
Light spot across entire abdomen 0 1 0 0
8.Primary Outcome
Title Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy With Valproate According to Dose of Lamotrigine Received
Hide Description The number of infants with the reported MCM following first trimester exposure to lamotrigine polytherapy with valproate were counted.
Time Frame Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth
Hide Outcome Measure Data
Hide Analysis Population Description
Among lamotrigine polytherapy with valproate exposures in the first trimester: live births, fetal deaths, induced abortions with defects, and live births without defects. Due to the likely inconsistent identification of defects among spontaneous losses, fetal deaths, and induced abortions without reported defects, those offspring were excluded.
Arm/Group Title Doses Lower Than Prescribed Prescribed Doses Doses Higher Than Prescribed Unknown Maximal Dose in Exposed Trimester
Hide Arm/Group Description:
>0 to 200 mg/day maximal dose in first trimester
201-400 mg/day maximal dose in first trimester
>400 mg/day maximal dose in first trimester
[Not Specified]
Overall Number of Participants Analyzed 13 3 0 0
Measure Type: Number
Unit of Measure: infants
Hydrocephalus/spina bifida 1 0
Meningomyelocele 1 0
Microcephaly 1 0
Orofacial clefts 2 1
Cardiac septal defects 0 2
Transposition of great vessels 1 0
Ventricular hypoplasia 1 0
Pulmonary stenosis 1 0
Pyloric stenosis 1 0
Gastroschisis 1 0
Club foot 2 0
Polydactyly 1 0
9.Primary Outcome
Title Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received
Hide Description The number of infants with the reported MCM following first trimester exposure to lamotrigine polytherapy without valproate were counted.
Time Frame Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth
Hide Outcome Measure Data
Hide Analysis Population Description
Among lamotrigine polytherapy without valproate exposures in the first trimester: live births, fetal deaths, induced abortions with defects, and live births without defects. Due to the likely inconsistent identification of defects among spontaneous losses, fetal deaths, and induced abortions without reported defects, those offspring were excluded.
Arm/Group Title Doses Lower Than Prescribed Prescribed Doses Doses Higher Than Prescribed Unknown Maximal Dose in Exposed Trimester
Hide Arm/Group Description:
>0 to 200 mg/day maximal dose in first trimester
201-400 mg/day maximal dose in first trimester
>400 mg/day maximal dose in first trimester
[Not Specified]
Overall Number of Participants Analyzed 2 4 6 0
Measure Type: Number
Unit of Measure: infants
Neural tube defect 0 0 1
Cardiac septal defect/murmur 0 1 1
Coarctation of aorta 0 1 0
Tetralogy of Fallot 0 0 1
Esophageal defects 0 1 1
Hypospadias 1 0 0
Hydroencephalopathy 1 0 0
Omphalocele 0 1 0
Extra digit 0 0 1
Skin tags on ear 0 0 1
Time Frame [Not Specified]
Adverse Event Reporting Description This was a prospective enrollment/follow-up study based on exposure/outcome data collected using structured enrollment and birth outcome report forms completed by healthcare providers of pregnant women. This observational study was designed to investigate birth defects, a specific group of serious adverse events (SAEs); no other SAEs were measured.
 
Arm/Group Title Lamotrigine Monotherapy Pregnancy Exposures Lamotrigine Polytherapy With Valproate Pregnancy Exposures Lamotrigine Polytherapy Without Valproate Pregnancy Exposures
Hide Arm/Group Description Prospectively enrolled pregnancies exposed to lamotrigine monotherapy with completed pregnancy outcome (does not include those lost to follow up where outcome information could not be obtained) Prospectively enrolled pregnancies exposed to lamotrigine polytherapy with valproate exposures with completed pregnancy outcome (does not include those lost to follow up where outcome information could not be obtained) Prospectively enrolled pregnancies exposed to lamotrigine polytherapy without valproate exposures with completed pregnancy outcome (does not include those lost to follow up where outcome information could not be obtained)
All-Cause Mortality
Lamotrigine Monotherapy Pregnancy Exposures Lamotrigine Polytherapy With Valproate Pregnancy Exposures Lamotrigine Polytherapy Without Valproate Pregnancy Exposures
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lamotrigine Monotherapy Pregnancy Exposures Lamotrigine Polytherapy With Valproate Pregnancy Exposures Lamotrigine Polytherapy Without Valproate Pregnancy Exposures
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   35/1776 (1.97%)   16/171 (9.36%)   12/497 (2.41%) 
Congenital, familial and genetic disorders       
Anencephaly  3/1776 (0.17%)  0/171 (0.00%)  0/497 (0.00%) 
Cardiac septal defect/murmur  0/1776 (0.00%)  2/171 (1.17%)  2/497 (0.40%) 
Club foot  3/1776 (0.17%)  2/171 (1.17%)  0/497 (0.00%) 
Coarctation of aorta  0/1776 (0.00%)  0/171 (0.00%)  1/497 (0.20%) 
Congenital atresia of anus  1/1776 (0.06%)  0/171 (0.00%)  0/497 (0.00%) 
Cortical dysplasis  1/1776 (0.06%)  0/171 (0.00%)  0/497 (0.00%) 
Diaphragmatic hernia  2/1776 (0.11%)  0/171 (0.00%)  0/497 (0.00%) 
Epidermolysis bullosa  1/1776 (0.06%)  0/171 (0.00%)  0/497 (0.00%) 
Esophageal defects  0/1776 (0.00%)  0/171 (0.00%)  2/497 (0.40%) 
Gastroschisis  0/1776 (0.00%)  1/171 (0.58%)  0/497 (0.00%) 
Hip dislocation  1/1776 (0.06%)  0/171 (0.00%)  0/497 (0.00%) 
Hydrocephalus/spina bifida  0/1776 (0.00%)  1/171 (0.58%)  0/497 (0.00%) 
Hydroencephalopathy  0/1776 (0.00%)  0/171 (0.00%)  1/497 (0.20%) 
Hydronephrosis  2/1776 (0.11%)  0/171 (0.00%)  0/497 (0.00%) 
Hypoplastic left heart/left ventricle hypoplasia  2/1776 (0.11%)  0/171 (0.00%)  0/497 (0.00%) 
Hypospadias  2/1776 (0.11%)  0/171 (0.00%)  1/497 (0.20%) 
Light spot across entire abdomen  1/1776 (0.06%)  0/171 (0.00%)  0/497 (0.00%) 
Meningomyelocele  0/1776 (0.00%)  1/171 (0.58%)  0/497 (0.00%) 
Microcephaly  0/1776 (0.00%)  1/171 (0.58%)  0/497 (0.00%) 
Minor heart defect, unspecified  1/1776 (0.06%)  0/171 (0.00%)  0/497 (0.00%) 
Neural tube defect  0/1776 (0.00%)  0/171 (0.00%)  1/497 (0.20%) 
Omphalocele  0/1776 (0.00%)  0/171 (0.00%)  1/497 (0.20%) 
Orofacial clefts  2/1776 (0.11%)  3/171 (1.75%)  0/497 (0.00%) 
Polydactyly  2/1776 (0.11%)  1/171 (0.58%)  1/497 (0.20%) 
Pulmonary stenosis  1/1776 (0.06%)  1/171 (0.58%)  0/497 (0.00%) 
Pyloric stenosis  2/1776 (0.11%)  1/171 (0.58%)  0/497 (0.00%) 
Renal defect (absent, polysystic, fluid on kidney)  3/1776 (0.17%)  0/171 (0.00%)  0/497 (0.00%) 
Skin tags on ear  0/1776 (0.00%)  0/171 (0.00%)  1/497 (0.20%) 
Tetralogy of Fallot  0/1776 (0.00%)  0/171 (0.00%)  1/497 (0.20%) 
Transposition of great vessels  2/1776 (0.11%)  1/171 (0.58%)  0/497 (0.00%) 
Ventricular hypoplasia  0/1776 (0.00%)  1/171 (0.58%)  0/497 (0.00%) 
Ventricular septal defects  3/1776 (0.17%)  0/171 (0.00%)  0/497 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lamotrigine Monotherapy Pregnancy Exposures Lamotrigine Polytherapy With Valproate Pregnancy Exposures Lamotrigine Polytherapy Without Valproate Pregnancy Exposures
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01064297     History of Changes
Other Study ID Numbers: 112913
105905 ( Other Identifier: GSK )
EPI40048 ( Other Identifier: GSK )
First Submitted: January 28, 2010
First Posted: February 8, 2010
Results First Submitted: June 14, 2010
Results First Posted: October 11, 2010
Last Update Posted: February 25, 2013