Study: NCT01378273

Adverse event: Polycythaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Hematocrit \> 65
Frequency: 1 affected / 460 at risk

Adverse event: Major Thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 460 at risk

Adverse event: Severe pulmonary hemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 460 at risk

Adverse event: Necrotising colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 460 at risk

Adverse event: Severe sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Culture positive and symptomatic
Frequency: 38 affected / 460 at risk

Adverse event: Severe intracranial hemorrhage
Serious: yes
Organ System: Nervous system disorders
Notes: Grade III or IV
Frequency: 64 affected / 460 at risk

Adverse event: Severe retinopathy of prematurity
Serious: yes
Organ System: Eye disorders
Notes: Requiring treatment
Frequency: 30 affected / 460 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Notes: Requiring treatment
Frequency: 10 affected / 460 at risk

Adverse event: Nonfatal cardiac arrest
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 460 at risk

Adverse event: Other unexpected life-threatening events
Serious: yes
Organ System: General disorders
Frequency: 31 affected / 460 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 45 affected / 460 at risk

Adverse event: Bronchopulmonary dysplasia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 161 affected / 460 at risk

Adverse event: Treated patent ductus arteriosus
Serious: no
Organ System: Cardiac disorders
Frequency: 172 affected / 460 at risk

Adverse event: Necrotising colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 53 affected / 460 at risk

Adverse event: Intracranial hemorrhage (all grades)
Serious: no
Organ System: Nervous system disorders
Frequency: 181 affected / 460 at risk

Adverse event: Periventricular leukomalasia
Serious: no
Organ System: Nervous system disorders
Frequency: 43 affected / 460 at risk

Adverse event: Cerebellar haemorrhage
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 460 at risk

Adverse event: Retinopathy of Prematurity (all grades)
Serious: no
Organ System: Eye disorders
Frequency: 258 affected / 460 at risk

Adverse event: Transfusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 401 affected / 460 at risk

Adverse event: Polycythaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Hematocrit \> 65
Frequency: 2 affected / 476 at risk

Adverse event: Major Thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 476 at risk

Adverse event: Severe pulmonary hemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 30 affected / 476 at risk

Adverse event: Necrotising colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 476 at risk

Adverse event: Severe sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Culture positive and symptomatic
Frequency: 35 affected / 476 at risk

Adverse event: Severe intracranial hemorrhage
Serious: yes
Organ System: Nervous system disorders
Notes: Grade III or IV
Frequency: 57 affected / 476 at risk

Adverse event: Severe retinopathy of prematurity
Serious: yes
Organ System: Eye disorders
Notes: Requiring treatment
Frequency: 30 affected / 476 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Notes: Requiring treatment
Frequency: 6 affected / 476 at risk

Adverse event: Nonfatal cardiac arrest
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 476 at risk

Adverse event: Other unexpected life-threatening events
Serious: yes
Organ System: General disorders
Frequency: 27 affected / 476 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 53 affected / 476 at risk

Adverse event: Bronchopulmonary dysplasia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 172 affected / 476 at risk

Adverse event: Treated patent ductus arteriosus
Serious: no
Organ System: Cardiac disorders
Frequency: 178 affected / 476 at risk

Adverse event: Necrotising colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 46 affected / 476 at risk

Adverse event: Intracranial hemorrhage (all grades)
Serious: no
Organ System: Nervous system disorders
Frequency: 168 affected / 476 at risk

Adverse event: Periventricular leukomalasia
Serious: no
Organ System: Nervous system disorders
Frequency: 41 affected / 476 at risk

Adverse event: Cerebellar haemorrhage
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 476 at risk

Adverse event: Retinopathy of Prematurity (all grades)
Serious: no
Organ System: Eye disorders
Frequency: 244 affected / 476 at risk

Adverse event: Transfusion
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 341 affected / 476 at risk