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Table 3 All observed major and minor birth defects (per MACDP criteria [25]) by organ system

From: Evaluation of pregnancy outcomes from the Tysabri® (natalizumab) pregnancy exposure registry: a global, observational, follow-up study

Organ system, birth defect

Major or minor birth defect

Number of events (n = 57)

Musculoskeletal (n = 11)

 Plagiocephalya

Minor

4

 Torticollisa

Major

4

 Hip dysplasia

Major

1

 Polydactyly

Major

1

 Absent right femur

Major

1

Cardiovascular (n = 10)

 Ventricular septal defectb

Major

3

 Patent foramen ovalec

Minor

2

 Atrial shunt

Major

1

 Patent ductus arteriosusc

Minor

1

 Supraventricular tachycardia

Minor

1

 Tetralogy of Fallot

Major

1

 Tricuspid valve atresia

Major

1

Skin (n = 9)

 Hemangioma

Minor

2

 Café-au-lait spot

Minor

1

 Irregular tragus

Minor

1

 Mongolian spot

Minor

1

 Small anterior fontanelle

Minor

1

 Subcutaneous cyst

Minor

1

 Unspecified anomaly of nose

Major

1

 Unspecified anomaly of toes

Minor

1

Genital disorders (n = 8)

 Chordee

Minor

2

 Hydrocele

Minor

2

 Undescended testicle

Minor

2

 Chordee with hypospadias

Major

1

 Penile concealment

Major

1

Neurologic (n = 6)

 Colpocephaly

Major

1

 Holoprosencephaly

Major

1

 Hydrocephalus

Major

1

 Myelomeningocele

Major

1

 Sacral dimple

Minor

1

 Unspecified agenesis of corpus callosum

Major

1

Renal (n = 5)

 Hydronephrosis

Major

2

 Cystic dysplasia

Major

1

 Renal dilation

Minor

1

 Vesicoureteral reflux

Major

1

Gastrointestinal (n = 4)

 Umbilical hernia

Minor

2

 Inguinal hernia

Minor

1

 Tight frenulum

Minor

1

Chromosome (n = 1)

 Partial trisomy 9d

Major

1

Endocrine (n = 1)

 Congenital hypothyroidism

Minor

1

Metabolic (n = 1)

 Phenylketonuria

Major

1

Ocular (n = 1)

 Disconjugate gaze

Major

1

  1. aThree cases of plagiocephaly and 2 cases of torticollis occurred in 2 sets of twins
  2. bNo cases occurred in a premature birth (i.e., <37 weeks)
  3. cOne case occurred in a premature birth (35 weeks 4 days’ gestation)
  4. dMaternal age was 46 years at enrollment