Study: NCT00135707

Adverse event: Peripartum cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Notes: Peripartum Cardiomyopathy resulting in death.
Frequency: 1 affected / 5087 at risk

Adverse event: Foetal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Miscarriage, stillbirth, abortion
Frequency: 45 affected / 5087 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Placental abruption, vaginal bleeding
Frequency: 9 affected / 5087 at risk

Adverse event: Renal and Urinary disorders
Serious: yes
Organ System: Renal and urinary disorders
Notes: Pyelonephritis and Urinary Tract Infection
Frequency: 4 affected / 5087 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Postpartum hemorrhage, blood transfusion, hysterectomy
Frequency: 4 affected / 5087 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Group A strep sepsis, bacterial/ viral meningitis, cellulitis, sepsis, bacterial infection
Frequency: 5 affected / 5087 at risk

Adverse event: Respiratory distress/pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5087 at risk

Adverse event: DVT/PE
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Deep vein thrombosis, pulmonary embolism
Frequency: 2 affected / 5087 at risk

Adverse event: Colon resection
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 5087 at risk

Adverse event: Hodgkin's disease
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 5087 at risk

Adverse event: Fetal birth defects
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 6 affected / 5087 at risk

Adverse event: Fetal atrial flutter/arrythmia/bradycardia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 5087 at risk

Adverse event: Neonatal death
Serious: yes
Organ System: General disorders
Frequency: 20 affected / 5087 at risk

Adverse event: Infant Seizures
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 5087 at risk

Adverse event: Birth injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 5087 at risk

Adverse event: Infant low platelet count
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 5087 at risk

Adverse event: Infant - Soft Tissue Mass
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 5087 at risk

Adverse event: Hypoxic Events
Serious: yes
Organ System: Nervous system disorders
Notes: Hypoxic birth injury, hypoxic ischemic encephalopathy, ischemic stroke
Frequency: 2 affected / 5087 at risk

Adverse event: Peripartum cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Notes: Peripartum Cardiomyopathy resulting in death.
Frequency: 1 affected / 5065 at risk

Adverse event: Foetal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Miscarriage, stillbirth, abortion
Frequency: 95 affected / 5065 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Placental abruption, vaginal bleeding
Frequency: 7 affected / 5065 at risk

Adverse event: Renal and Urinary disorders
Serious: yes
Organ System: Renal and urinary disorders
Notes: Pyelonephritis and Urinary Tract Infection
Frequency: 9 affected / 5065 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Postpartum hemorrhage, blood transfusion, hysterectomy
Frequency: 5 affected / 5065 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Group A strep sepsis, bacterial/ viral meningitis, cellulitis, sepsis, bacterial infection
Frequency: 2 affected / 5065 at risk

Adverse event: Respiratory distress/pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5065 at risk

Adverse event: DVT/PE
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Deep vein thrombosis, pulmonary embolism
Frequency: 1 affected / 5065 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 5065 at risk

Adverse event: Fetal birth defects
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 21 affected / 5065 at risk

Adverse event: Fetal atrial flutter/arrythmia/bradycardia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 5065 at risk

Adverse event: Neonatal death
Serious: yes
Organ System: General disorders
Frequency: 27 affected / 5065 at risk

Adverse event: Birth injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 5065 at risk

Adverse event: Umbilical hernia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5065 at risk