Study: NCT01064297

Adverse event: Anencephaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 3 affected / 1776 at risk

Adverse event: Club foot
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 3 affected / 1776 at risk

Adverse event: Congenital atresia of anus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1776 at risk

Adverse event: Cortical dysplasis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1776 at risk

Adverse event: Diaphragmatic hernia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 1776 at risk

Adverse event: Epidermolysis bullosa
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1776 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1776 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 1776 at risk

Adverse event: Hypoplastic left heart/left ventricle hypoplasia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 1776 at risk

Adverse event: Hypospadias
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 1776 at risk

Adverse event: Light spot across entire abdomen
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1776 at risk

Adverse event: Minor heart defect, unspecified
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1776 at risk

Adverse event: Orofacial clefts
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 1776 at risk

Adverse event: Polydactyly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 1776 at risk

Adverse event: Pulmonary valve stenosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1776 at risk

Adverse event: Pyloric stenosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 1776 at risk

Adverse event: Renal defect (absent, polysystic, fluid on kidney)
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 3 affected / 1776 at risk

Adverse event: Transposition of the great vessels
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 1776 at risk

Adverse event: Ventricular septal defects
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 3 affected / 1776 at risk

Adverse event: Cardiac septal defect/murmur
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 171 at risk

Adverse event: Club foot
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 171 at risk

Adverse event: Gastroschisis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 171 at risk

Adverse event: Hydrocephalus/spina bifida
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 171 at risk

Adverse event: Meningomyelocele
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 171 at risk

Adverse event: Microcephaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 171 at risk

Adverse event: Orofacial clefts
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 3 affected / 171 at risk

Adverse event: Polydactyly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 171 at risk

Adverse event: Pulmonary valve stenosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 171 at risk

Adverse event: Pyloric stenosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 171 at risk

Adverse event: Transposition of the great vessels
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 171 at risk

Adverse event: Ventricular hypoplasia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 171 at risk

Adverse event: Cardiac septal defect/murmur
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 497 at risk

Adverse event: Coarctation of the aorta
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 497 at risk

Adverse event: Esophageal defects
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 497 at risk

Adverse event: Hydroencephalopathy
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 497 at risk

Adverse event: Hypospadias
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 497 at risk

Adverse event: Neural tube defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 497 at risk

Adverse event: Exomphalos
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 497 at risk

Adverse event: Polydactyly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 497 at risk

Adverse event: Skin tags on ear
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 497 at risk

Adverse event: Fallot's tetralogy
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 497 at risk