Study: NCT04296396

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Notes: includes cardiac arrest and coarctation of aorta
Frequency: 1 affected / 2748 at risk

Adverse event: Angiodysplasia of duodenum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2748 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2748 at risk

Adverse event: Mastitis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 2748 at risk

Adverse event: Abdominal adhesions
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2748 at risk

Adverse event: Heavy vaginal bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2748 at risk

Adverse event: Intra-abdominal fluid collection
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2748 at risk

Adverse event: Postpartum endometritis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 8 affected / 2748 at risk

Adverse event: Thrombophlebitis septic
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2748 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2748 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2748 at risk

Adverse event: Intraparenchymal hemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 2748 at risk

Adverse event: Embolism venous
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2748 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2748 at risk

Adverse event: Cholecystectomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 2748 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 2748 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2748 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 2748 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2748 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 2748 at risk

Adverse event: Glioblastoma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2748 at risk

Adverse event: Postpartum preeclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 62 affected / 2748 at risk

Adverse event: Bipolar disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2748 at risk

Adverse event: Panic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2748 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2748 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 2748 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2748 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2748 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2748 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2748 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 2748 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 2748 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2748 at risk

Adverse event: Abscess
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 2748 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2748 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 2748 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2748 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 166 affected / 2748 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2772 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 2772 at risk

Adverse event: Mastitis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2772 at risk

Adverse event: Postpartum endometritis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 9 affected / 2772 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 2772 at risk

Adverse event: Myocardial infarction type 2
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2772 at risk

Adverse event: New onset diastolic heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2772 at risk

Adverse event: Lower extremity swelling
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2772 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2772 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2772 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 2772 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2772 at risk

Adverse event: Postpartum preeclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 54 affected / 2772 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2772 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 2772 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2772 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2772 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 2772 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2772 at risk

Adverse event: Abscess
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 2772 at risk

Adverse event: Incisional bleeding
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2772 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 2772 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2772 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 186 affected / 2772 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 2856 at risk

Adverse event: Neonatal death
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 2856 at risk

Adverse event: Polydactyly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 2856 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2856 at risk

Adverse event: Distal bowel stricture
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2856 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2856 at risk

Adverse event: Meconium pseudocyst and volvulous
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2856 at risk

Adverse event: Feeding disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 2856 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2856 at risk

Adverse event: Suspected congenital adrenal hyperplasia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 2856 at risk

Adverse event: Trisomy 18
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 2856 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2856 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 2856 at risk

Adverse event: Encephalomalacia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2856 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2856 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 2856 at risk

Adverse event: Cystitis escherichia
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2856 at risk

Adverse event: Hypothermia
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 2856 at risk

Adverse event: Neonatal death
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 2889 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 2889 at risk

Adverse event: Mastitis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2889 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2889 at risk

Adverse event: Intrauterine bowel perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2889 at risk

Adverse event: Weight gain poor
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2889 at risk

Adverse event: Pale/Stiff
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 2889 at risk

Adverse event: Coarctation of the aorta
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 2889 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 2889 at risk

Adverse event: Hypospadias
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 2889 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 2889 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 2889 at risk

Adverse event: Hypothermia
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 2889 at risk