Study: NCT00201643

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 512 at risk

Adverse event: Congenital Defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: to include: Congenital heart defects, hypospadias, inguinal hernia, hydrocele, dysmorphology, Cleft Lip, VATERS.
Frequency: 8 affected / 289 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 289 at risk

Adverse event: Cardiac dysfunction
Serious: yes
Organ System: Cardiac disorders
Notes: Arrhythmias, cardiomyopathy, hypoperfusion
Frequency: 5 affected / 289 at risk

Adverse event: NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 289 at risk

Adverse event: Hyperbilirubenemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 289 at risk

Adverse event: Wound infections
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 223 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 289 at risk

Adverse event: Post delivery/C/S hemorrage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 223 at risk

Adverse event: Spinal Headache
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 223 at risk

Adverse event: PVL
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 289 at risk

Adverse event: Intraventicular Hemorrage (Grade III, IV)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 289 at risk

Adverse event: Perinatal fetal demise
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 289 at risk

Adverse event: D & C for retained products
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 223 at risk

Adverse event: Apnea/respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 289 at risk

Adverse event: Pulmonary Disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Bronchiolitis, Pulmonary Interstitial Glycogenesis
Frequency: 2 affected / 289 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 502 at risk

Adverse event: Congenital Defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: to include: Congenital heart defects, hypospadias, inguinal hernia, hydrocele, dysmorphology, Cleft Lip, VATERS.
Frequency: 12 affected / 288 at risk

Adverse event: Disseminated intravascular coagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 502 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 288 at risk

Adverse event: Cardiac dysfunction
Serious: yes
Organ System: Cardiac disorders
Notes: Arrhythmias, cardiomyopathy, hypoperfusion
Frequency: 2 affected / 288 at risk

Adverse event: NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 288 at risk

Adverse event: Small Bowel Rotation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 288 at risk

Adverse event: Hyperbilirubenemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 288 at risk

Adverse event: Hepatosplenomegally
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 288 at risk

Adverse event: Wound infections
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 214 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 288 at risk

Adverse event: Mastitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 214 at risk

Adverse event: Post delivery/C/S hemorrage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 214 at risk

Adverse event: soft tissue rectal mass
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 288 at risk

Adverse event: Intraoperative Bladder Tear
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 214 at risk

Adverse event: Intraventicular Hemorrage (Grade III, IV)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 288 at risk

Adverse event: Perinatal fetal demise
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 288 at risk

Adverse event: D & C for retained products
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 214 at risk

Adverse event: Abruption
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 214 at risk

Adverse event: Apnea/respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 288 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 214 at risk

Adverse event: Appendicitis perforated
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 214 at risk

Adverse event: Crohn's disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 502 at risk