Study: NCT03364491

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 5529 at risk

Adverse event: Heart failure/ Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 5529 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 5529 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 5529 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5529 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 5529 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 5529 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5529 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 5529 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 5529 at risk

Adverse event: neonatal drug withdrawal
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 5529 at risk

Adverse event: cholelithiasis/ cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 5529 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 5529 at risk

Adverse event: Myasthenia gravis
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 5529 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 5529 at risk

Adverse event: Necrotising soft tissue infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 5529 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 5529 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 5529 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 5529 at risk

Adverse event: Wound dehiscence, seroma, hematoma, or cellulitis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 5529 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 5529 at risk

Adverse event: Spinal headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 5529 at risk

Adverse event: Neonatal Seizure/stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 5529 at risk

Adverse event: Neonatal cerebral arterial or venous infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 5529 at risk

Adverse event: Preeclampsia and associated complications
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 28 affected / 5529 at risk

Adverse event: Mastitis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 5529 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 5529 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 5529 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5529 at risk

Adverse event: Air embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 5529 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 5529 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 5529 at risk

Adverse event: Neonatal thrombosis or occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 5529 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 363 affected / 5529 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 266 affected / 5529 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 157 affected / 5529 at risk

Adverse event: Urticaria or dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 63 affected / 5529 at risk

Adverse event: Cardiomegaly
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 5471 at risk

Adverse event: Heart failure/ Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 5471 at risk

Adverse event: Intra-abdominal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5471 at risk

Adverse event: Nausea/vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5471 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5471 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5471 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5471 at risk

Adverse event: cholelithiasis/ cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 5471 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 5471 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 5471 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 5471 at risk

Adverse event: Septic Thrombophlebitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 5471 at risk

Adverse event: other undefined infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 5471 at risk

Adverse event: Wound dehiscence, seroma, hematoma, or cellulitis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 5471 at risk

Adverse event: Neonatal vascular access complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 5471 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 5471 at risk

Adverse event: Bell's palsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 5471 at risk

Adverse event: Neonatal cerebral arterial or venous infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 5471 at risk

Adverse event: Neonatal hypotonia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 5471 at risk

Adverse event: Preeclampsia and associated complications
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 22 affected / 5471 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 5471 at risk

Adverse event: Pyschosis
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 5471 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 5471 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5471 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5471 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 5471 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 5471 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 5471 at risk

Adverse event: Neonatal thrombosis or occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 5471 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 5471 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 404 affected / 5471 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 273 affected / 5471 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 186 affected / 5471 at risk

Adverse event: Urticaria or dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 72 affected / 5471 at risk