Study: NCT02059135

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: HELLP syndrome
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 60 at risk

Adverse event: Intrapartum haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 60 at risk

Adverse event: Postpartum haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 60 at risk

Adverse event: Premature separation of placenta
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 60 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 60 at risk

Adverse event: Foetal growth restriction
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 60 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 32 affected / 60 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 24 affected / 60 at risk

Adverse event: Pre-eclampsia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 20 affected / 60 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 60 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 9 affected / 60 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 60 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 60 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 60 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 60 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 60 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 60 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 60 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 60 at risk

Adverse event: Infusion site extravasation
Serious: no
Organ System: General disorders
Frequency: 4 affected / 60 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 60 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 60 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 4 affected / 60 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 60 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 60 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 60 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 60 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 60 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 60 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 60 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 60 at risk

Adverse event: Perinatal depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 60 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 60 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Abdominal wall haematoma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 54 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 54 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 54 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 54 at risk

Adverse event: Venous thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 54 at risk

Adverse event: Nonreassuring foetal heart rate pattern
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 54 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 25 affected / 54 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 19 affected / 54 at risk

Adverse event: Pre-eclampsia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 12 affected / 54 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 54 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 54 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 54 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 54 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 54 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 54 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 54 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 54 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 54 at risk

Adverse event: Infusion site extravasation
Serious: no
Organ System: General disorders
Frequency: 15 affected / 54 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 54 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 54 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 2 affected / 54 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 54 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 54 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 54 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 54 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 54 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 54 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 54 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 54 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 54 at risk

Adverse event: Perinatal depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 54 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 54 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 54 at risk

Adverse event: Hypospadias
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 60 at risk

Adverse event: Persistent foetal circulation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 60 at risk

Adverse event: Neonatal intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Sepsis neonatal
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 60 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 60 at risk

Adverse event: Intraventricular haemorrhage neonatal
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 60 at risk

Adverse event: Periventricular leukomalacia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 60 at risk

Adverse event: Small for dates baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 60 at risk

Adverse event: Bronchopulmonary dysplasia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 60 at risk

Adverse event: Hypercapnia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Neonatal respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 60 at risk

Adverse event: Neonatal respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Necrotising enterocolitis neonatal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 54 at risk

Adverse event: Meningitis neonatal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 54 at risk

Adverse event: Sepsis neonatal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 54 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 54 at risk

Adverse event: Intraventricular haemorrhage neonatal
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 54 at risk

Adverse event: Periventricular leukomalacia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 54 at risk

Adverse event: Premature baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 54 at risk

Adverse event: Small for dates baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 54 at risk

Adverse event: Bronchopulmonary dysplasia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 54 at risk

Adverse event: Neonatal respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 54 at risk

Adverse event: Neonatal respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 54 at risk

Adverse event: Respiratory tract haemorrhage neonatal
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 54 at risk