Study: NCT00703014

Adverse event: Blood loss anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 274 at risk

Adverse event: Bradycardia foetal
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 274 at risk

Adverse event: Tachycardia foetal
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 274 at risk

Adverse event: Anaphylactic shock
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 274 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 274 at risk

Adverse event: Genital herpes
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 274 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 274 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 274 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 274 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 274 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 274 at risk

Adverse event: Amniotic fluid volume decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 274 at risk

Adverse event: Foetal heart rate abnormal
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 274 at risk

Adverse event: Foetal heart rate decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 274 at risk

Adverse event: Hepatic enzyme increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 274 at risk

Adverse event: Gestational diabetes
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 274 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 274 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 274 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 274 at risk

Adverse event: Superior sagittal sinus thrombosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 274 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 274 at risk

Adverse event: Haemorrhage in pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 274 at risk

Adverse event: Arrested labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 12 affected / 274 at risk

Adverse event: Breech presentation
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 26 affected / 274 at risk

Adverse event: Cephalo-pelvic disproportion
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 274 at risk

Adverse event: Cervical incompetence
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 274 at risk

Adverse event: Amniotic cavity infection
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 274 at risk

Adverse event: Face presentation
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 274 at risk

Adverse event: Failed induction of labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 274 at risk

Adverse event: Foetal distress syndrome
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 274 at risk

Adverse event: Foetal growth restriction
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 274 at risk

Adverse event: Foetal hypokinesia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 274 at risk

Adverse event: Foetal malpresentation
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 274 at risk

Adverse event: HELLP syndrome
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 274 at risk

Adverse event: Imminent abortion
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 274 at risk

Adverse event: Multiple pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 274 at risk

Adverse event: Oligohydramnios
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 274 at risk

Adverse event: Placenta praevia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 274 at risk

Adverse event: Postpartum haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 274 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 12 affected / 274 at risk

Adverse event: Gestational hypertension
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 274 at risk

Adverse event: Premature labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 37 affected / 274 at risk

Adverse event: Premature rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 8 affected / 274 at risk

Adverse event: Premature separation of placenta
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 274 at risk

Adverse event: Previous caesarean section
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 274 at risk

Adverse event: Prolonged labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 274 at risk

Adverse event: Stillbirth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 274 at risk

Adverse event: Threatened labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 10 affected / 274 at risk

Adverse event: Transverse presentation
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 274 at risk

Adverse event: Twin pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 16 affected / 274 at risk

Adverse event: Umbilical cord prolapse
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 274 at risk

Adverse event: Uterine contractions during pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 274 at risk

Adverse event: Post-traumatic stress disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 274 at risk

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 274 at risk

Adverse event: Ovarian enlargement
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 274 at risk

Adverse event: Ovarian hyperstimulation syndrome
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 274 at risk

Adverse event: Pelvic pain
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 274 at risk

Adverse event: Uterine atony
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 274 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 274 at risk

Adverse event: Pruritus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 274 at risk

Adverse event: Abortion induced
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 274 at risk

Adverse event: Evacuation of retained products of conception
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 274 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 274 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 274 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 274 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 274 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 274 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 17 affected / 274 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 21 affected / 274 at risk

Adverse event: Gestational diabetes
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 10 affected / 274 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 25 affected / 274 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 24 affected / 274 at risk

Adverse event: Haemorrhage in pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 19 affected / 274 at risk

Adverse event: Threatened labour
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 18 affected / 274 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 14 affected / 274 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 274 at risk

Adverse event: Placental transfusion syndrome
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 267 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 267 at risk

Adverse event: Bradycardia foetal
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 267 at risk

Adverse event: Tachycardia foetal
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 267 at risk

Adverse event: Eye disorder
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 267 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 267 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 267 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 267 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 267 at risk

Adverse event: Foetal heart rate abnormal
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 267 at risk

Adverse event: Foetal heart rate decreased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 267 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 267 at risk

Adverse event: Arrested labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 15 affected / 267 at risk

Adverse event: Breech presentation
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 23 affected / 267 at risk

Adverse event: Caput succedaneum
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 267 at risk

Adverse event: Cephalo-pelvic disproportion
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 267 at risk

Adverse event: Cervical incompetence
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 267 at risk

Adverse event: Amniotic cavity infection
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 267 at risk

Adverse event: Face presentation
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 267 at risk

Adverse event: Failed induction of labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 267 at risk

Adverse event: Foetal distress syndrome
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 13 affected / 267 at risk

Adverse event: Foetal growth restriction
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 267 at risk

Adverse event: Foetal macrosomia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 267 at risk

Adverse event: Foetal malposition
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 267 at risk

Adverse event: Foetal malpresentation
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 267 at risk

Adverse event: Hyperemesis gravidarum
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 267 at risk

Adverse event: Intrapartum haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 267 at risk

Adverse event: Meconium in amniotic fluid
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 267 at risk

Adverse event: Meconium in amniotic fluid
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 267 at risk

Adverse event: Oligohydramnios
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 267 at risk

Adverse event: Placenta accreta
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 267 at risk

Adverse event: Placenta praevia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 267 at risk

Adverse event: Polyhydramnios
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 267 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 10 affected / 267 at risk

Adverse event: Gestational hypertension
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 267 at risk

Adverse event: Premature labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 33 affected / 267 at risk

Adverse event: Premature rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 267 at risk

Adverse event: Premature separation of placenta
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 267 at risk

Adverse event: Previous caesarean section
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 267 at risk

Adverse event: Prolonged labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 267 at risk

Adverse event: Stillbirth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 267 at risk

Adverse event: Threatened labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 11 affected / 267 at risk

Adverse event: Transverse presentation
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 267 at risk

Adverse event: Twin pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 15 affected / 267 at risk

Adverse event: Umbilical cord abnormality
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 267 at risk

Adverse event: Umbilical cord prolapse
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 267 at risk

Adverse event: Uterine hypotonus
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 267 at risk

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 267 at risk

Adverse event: Cervix oedema
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 267 at risk

Adverse event: Haemorrhagic ovarian cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 267 at risk

Adverse event: Adnexal torsion
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 267 at risk

Adverse event: Shortened cervix
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 267 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 267 at risk

Adverse event: Abortion induced
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 267 at risk

Adverse event: Caesarean section
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 267 at risk

Adverse event: Labour induction
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 267 at risk

Adverse event: Selective abortion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 267 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 267 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 267 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 267 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 267 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 267 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 267 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 15 affected / 267 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 13 affected / 267 at risk

Adverse event: Gestational diabetes
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 267 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 20 affected / 267 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 31 affected / 267 at risk

Adverse event: Haemorrhage in pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 14 affected / 267 at risk

Adverse event: Threatened labour
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 15 affected / 267 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 10 affected / 267 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 267 at risk

Adverse event: Anaemia neonatal
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 352 at risk

Adverse event: Thrombocytopenia neonatal
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 352 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 352 at risk

Adverse event: Cardio-respiratory arrest neonatal
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 352 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 352 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 352 at risk

Adverse event: Abnormal palmar/planta creases
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 352 at risk

Adverse event: Accessory auricle
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 352 at risk

Adverse event: Tethered oral tissue
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 352 at risk

Adverse event: Atrial septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 5 affected / 352 at risk

Adverse event: Protuberant ear
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 352 at risk

Adverse event: Supernumerary rib
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 352 at risk

Adverse event: Cleft lip
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 352 at risk

Adverse event: Cleft palate
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 352 at risk

Adverse event: Clinodactyly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 352 at risk

Adverse event: Congenital anaemia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 352 at risk

Adverse event: Congenital aortic anomaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 352 at risk

Adverse event: Congenital aortic stenosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 352 at risk

Adverse event: Congenital aortic valve stenosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 352 at risk

Adverse event: Congenital central nervous system anomaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 3 affected / 352 at risk

Adverse event: Congenital cerebral cyst
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 352 at risk

Adverse event: Congenital eyelid malformation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 352 at risk

Adverse event: Congenital hearing disorder
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 352 at risk

Adverse event: Congenital hydrocephalus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 352 at risk

Adverse event: Congenital inguinal hernia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 352 at risk

Adverse event: Congenital mitral valve stenosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 352 at risk

Adverse event: Congenital optic nerve anomaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 352 at risk

Adverse event: Congenital spinal cord anomaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 352 at risk

Adverse event: Cryptorchism
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 352 at risk

Adverse event: Dacryostenosis congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 3 affected / 352 at risk

Adverse event: Exomphalos
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 7 affected / 352 at risk

Adverse event: Eyelid ptosis congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 352 at risk

Adverse event: Fallot's tetralogy
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 352 at risk

Adverse event: Haemangioma congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 4 affected / 352 at risk

Adverse event: Heart disease congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 352 at risk

Adverse event: Developmental hip dysplasia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 4 affected / 352 at risk

Adverse event: Hypertelorism
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 352 at risk

Adverse event: Hypospadias
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 352 at risk

Adverse event: Patent ductus arteriosus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 5 affected / 352 at risk

Adverse event: Phimosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 352 at risk

Adverse event: Pilonidal cyst congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 3 affected / 352 at risk

Adverse event: Plagiocephaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 352 at risk

Adverse event: Pulmonary artery stenosis congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 352 at risk

Adverse event: Pulmonary valve stenosis congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 352 at risk

Adverse event: Pyloric stenosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 352 at risk

Adverse event: Single umbilical artery
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 352 at risk

Adverse event: Congenital musculoskeletal disorder of skull
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 352 at risk

Adverse event: Supernumerary nipple
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 352 at risk

Adverse event: Syndactyly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 352 at risk

Adverse event: Talipes
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 352 at risk

Adverse event: Tracheo-oesophageal fistula
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 352 at risk

Adverse event: Hypoacusis
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 352 at risk

Adverse event: Secondary hypogonadism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 352 at risk

Adverse event: Dacryostenosis acquired
Serious: yes
Organ System: Eye disorders
Frequency: 5 affected / 352 at risk

Adverse event: Lacrimal cyst
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 352 at risk

Adverse event: Retinopathy of prematurity
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 352 at risk

Adverse event: Anal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 352 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 352 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 352 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 352 at risk

Adverse event: Intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 352 at risk

Adverse event: Fever neonatal
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 352 at risk

Adverse event: Inflammation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 352 at risk

Adverse event: Sudden infant death syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 352 at risk

Adverse event: Hyperbilirubinaemia neonatal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 9 affected / 352 at risk

Adverse event: Neonatal cholestasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 352 at risk

Adverse event: Bacterial sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 352 at risk

Adverse event: Klebsiella sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 352 at risk

Adverse event: Neonatal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 352 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 352 at risk

Adverse event: Sepsis neonatal
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 352 at risk

Adverse event: Blood sodium increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 352 at risk

Adverse event: Body temperature decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 352 at risk

Adverse event: C-reactive protein increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 352 at risk

Adverse event: Cardiac murmur
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 352 at risk

Adverse event: Foetal heart rate abnormal
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 352 at risk

Adverse event: Heart rate decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 352 at risk

Adverse event: Dairy intolerance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 352 at risk

Adverse event: Hypoglycaemia neonatal
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 352 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 352 at risk

Adverse event: Head deformity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 352 at risk

Adverse event: Joint range of motion decreased
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 352 at risk

Adverse event: Acquired plagiocephaly
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 352 at risk

Adverse event: Posture abnormal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 352 at risk

Adverse event: Cerebral haemorrhage neonatal
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 352 at risk

Adverse event: Neonatal seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 352 at risk

Adverse event: Encephalopathy neonatal
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 352 at risk

Adverse event: Neurological symptom
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 352 at risk

Adverse event: Discordant twin
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 352 at risk

Adverse event: Foetal distress syndrome
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 352 at risk

Adverse event: Jaundice neonatal
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 8 affected / 352 at risk

Adverse event: Premature baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 56 affected / 352 at risk

Adverse event: Small for dates baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 352 at risk

Adverse event: Agitation neonatal
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 352 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 352 at risk

Adverse event: Renal failure neonatal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 352 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 352 at risk

Adverse event: Brief resolved unexplained event
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 352 at risk

Adverse event: Atelectasis neonatal
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 352 at risk

Adverse event: Infantile apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 352 at risk

Adverse event: Neonatal hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 352 at risk

Adverse event: Neonatal respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 352 at risk

Adverse event: Neonatal respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 352 at risk

Adverse event: Respiratory disorder neonatal
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 352 at risk

Adverse event: Sleep apnoea syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 352 at risk

Adverse event: Hair growth abnormal
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 352 at risk

Adverse event: Hypertension neonatal
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 352 at risk

Adverse event: Neonatal hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 352 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 352 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 352 at risk

Adverse event: Jaundice neonatal
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 22 affected / 352 at risk

Adverse event: Anaemia neonatal
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 326 at risk

Adverse event: Splenomegaly
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 326 at risk

Adverse event: Thrombocytopenia neonatal
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 326 at risk

Adverse event: Bradycardia neonatal
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 326 at risk

Adverse event: Cardiac hypertrophy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 326 at risk

Adverse event: Nodal rhythm
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 326 at risk

Adverse event: Pulmonary valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 326 at risk

Adverse event: Accessory auricle
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 326 at risk

Adverse event: Tethered oral tissue
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 326 at risk

Adverse event: Atrial septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 11 affected / 326 at risk

Adverse event: Atrioventricular septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 326 at risk

Adverse event: Protuberant ear
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 326 at risk

Adverse event: Osteochondrodysplasia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 326 at risk

Adverse event: Cleft palate
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 326 at risk

Adverse event: Cleft uvula
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 326 at risk

Adverse event: Congenital choroid plexus cyst
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 3 affected / 326 at risk

Adverse event: Congenital coronary artery malformation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 326 at risk

Adverse event: Congenital cyst
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 326 at risk

Adverse event: Congenital eyelid malformation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 326 at risk

Adverse event: Congenital foot malformation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 326 at risk

Adverse event: Congenital hand malformation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 326 at risk

Adverse event: Developmental hip dysplasia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 3 affected / 326 at risk

Adverse event: Congenital hydrocephalus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 326 at risk

Adverse event: Congenital labia pudendi adhesions
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 326 at risk

Adverse event: Congenital naevus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 3 affected / 326 at risk

Adverse event: Congenital nose malformation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 326 at risk

Adverse event: Congenital ovarian anomaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 326 at risk

Adverse event: Congenital pyelocaliectasis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 326 at risk

Adverse event: Congenital torticollis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 326 at risk

Adverse event: Congenital tracheomalacia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 326 at risk

Adverse event: Craniotabes
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 326 at risk

Adverse event: Cryptorchism
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 326 at risk

Adverse event: Dacryostenosis congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 4 affected / 326 at risk

Adverse event: Duodenal atresia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 326 at risk

Adverse event: Exomphalos
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 3 affected / 326 at risk

Adverse event: Gastrointestinal malformation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 326 at risk

Adverse event: Haemangioma congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 3 affected / 326 at risk

Adverse event: Developmental hip dysplasia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 326 at risk

Adverse event: Hypospadias
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 326 at risk

Adverse event: Immunodeficiency congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 326 at risk

Adverse event: Patent ductus arteriosus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 6 affected / 326 at risk

Adverse event: Pilonidal cyst congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 326 at risk

Adverse event: Plagiocephaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 326 at risk

Adverse event: Pulmonary artery stenosis congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 326 at risk

Adverse event: Pulmonary valve stenosis congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 326 at risk

Adverse event: Pyloric stenosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 326 at risk

Adverse event: Rhesus haemolytic disease of newborn
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 326 at risk

Adverse event: Congenital musculoskeletal disorder of skull
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 326 at risk

Adverse event: Strabismus congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 326 at risk

Adverse event: Talipes
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 326 at risk

Adverse event: Trisomy 21
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 326 at risk

Adverse event: Ventricular septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 6 affected / 326 at risk

Adverse event: Hypoacusis
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 326 at risk

Adverse event: Dacryostenosis acquired
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 326 at risk

Adverse event: Retinopathy of prematurity
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 326 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 326 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 326 at risk

Adverse event: Necrotising enterocolitis neonatal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 326 at risk

Adverse event: Short-bowel syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 326 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 326 at risk

Adverse event: Drug withdrawal syndrome neonatal
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 326 at risk

Adverse event: Fever neonatal
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 326 at risk

Adverse event: Neonatal multi-organ faillure
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 326 at risk

Adverse event: Sudden infant death syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 326 at risk

Adverse event: Hyperbilirubinaemia neonatal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 326 at risk

Adverse event: Jaundice cholestatic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 326 at risk

Adverse event: Meningitis streptococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 326 at risk

Adverse event: Neonatal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 326 at risk

Adverse event: Neonatal pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 326 at risk

Adverse event: Oral candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 326 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 326 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 326 at risk

Adverse event: Sepsis neonatal
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 326 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 326 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 326 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 326 at risk

Adverse event: Acoustic stimulation tests abnormal
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 326 at risk

Adverse event: Blood glucose decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 326 at risk

Adverse event: Blood glucose fluctuation
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 326 at risk

Adverse event: Cardiac murmur
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 326 at risk

Adverse event: Cytomegalovirus test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 326 at risk

Adverse event: Haemoglobin Barts present
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 326 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 326 at risk

Adverse event: Fatty acid deficiency
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 326 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 326 at risk

Adverse event: Hypermagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 326 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 326 at risk

Adverse event: Hypoglycaemia neonatal
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 326 at risk

Adverse event: Loctose intolerance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 326 at risk

Adverse event: Neonatal hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 326 at risk

Adverse event: Hypotonia neonatal
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 326 at risk

Adverse event: Osteopenia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 326 at risk

Adverse event: Haemangioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 326 at risk

Adverse event: Haemangioma of skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 326 at risk

Adverse event: Lymphangioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 326 at risk

Adverse event: Brain oedema
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 326 at risk

Adverse event: Cerebral ventricle dilatation
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 326 at risk

Adverse event: Intraventricular haemorrhage neonatal
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 326 at risk

Adverse event: Discordant twin
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 326 at risk

Adverse event: Foetal distress syndrome
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 326 at risk

Adverse event: Hydrops foetalis
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 326 at risk

Adverse event: Jaundice neonatal
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 8 affected / 326 at risk

Adverse event: Premature baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 48 affected / 326 at risk

Adverse event: Small for dates baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 326 at risk

Adverse event: Umbilical cord around neck
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 326 at risk

Adverse event: Renal failure neonatal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 326 at risk

Adverse event: Renal tubular necrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 326 at risk

Adverse event: Chordee
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 326 at risk

Adverse event: Bronchopulmonary dysplasia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 326 at risk

Adverse event: Infantile apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 326 at risk

Adverse event: Neonatal hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 326 at risk

Adverse event: Neonatal respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 326 at risk

Adverse event: Neonatal respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 326 at risk

Adverse event: Neonatal tachypnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 326 at risk

Adverse event: Pneumomediastinum
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 326 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 326 at risk

Adverse event: Transient tachypnoea of the newborn
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 326 at risk

Adverse event: Appendicectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 326 at risk

Adverse event: Hypoperfusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 326 at risk

Adverse event: Lymphocele
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 326 at risk

Adverse event: Neonatal hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 326 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 326 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 326 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 326 at risk

Adverse event: Jaundice neonatal
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 20 affected / 326 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 326 at risk