TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03552536

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 5 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 5 at risk

Adverse event: Injury, poisoning and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Due to the nature of this Adverse Event and the small sample size for this study, the specific Adverse Event term for this Adverse Event is not disclosed due to patient confidentiality concerns.
Frequency: 1 affected / 5 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 5 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 5 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 5 at risk
Study: NCT03552575

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 47 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 47 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 47 at risk

Adverse event: Procedural hypotension
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 47 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 47 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 47 at risk

Adverse event: Worsening renal function or acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 47 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 47 at risk

Adverse event: Symptomatic hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 47 at risk

Adverse event: Symptomatic hypotension with systolic blood pressure <90mmHg
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 47 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 46 at risk

Adverse event: Worsening renal function or acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 46 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 46 at risk

Adverse event: Symptomatic hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 46 at risk
Study: NCT03553498

Adverse event: Oxygen Desaturation
Serious: no
Organ System: General disorders
Notes: Oxygen saturation less than 95%
Frequency: 3 affected / 80 at risk

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Notes: Systolic blood pressure less than 100 mm Hg
Frequency: 1 affected / 80 at risk

Adverse event: Nausea and/or Vomiting
Serious: no
Organ System: General disorders
Frequency: 6 affected / 80 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Frequency: 11 affected / 80 at risk

Adverse event: Oxygen Desaturation
Serious: no
Organ System: General disorders
Notes: Oxygen saturation less than 95%
Frequency: 1 affected / 79 at risk

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Notes: Systolic blood pressure less than 100 mm Hg
Frequency: 1 affected / 79 at risk

Adverse event: Bradycardia
Serious: no
Organ System: General disorders
Notes: Heart rate less than 50 beats per minute
Frequency: 1 affected / 79 at risk

Adverse event: Nausea and/or Vomiting
Serious: no
Organ System: General disorders
Frequency: 8 affected / 79 at risk

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Frequency: 12 affected / 79 at risk
Study: NCT03553823

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Dacryostenosis acquired
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 20 at risk

Adverse event: Erysipelas
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 20 at risk

Adverse event: Postoperative wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 20 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 20 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 20 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Balanoposthitis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 20 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dyshidrotic eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk
Study: NCT03554018

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 60 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 60 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk
Study: NCT03554486

Adverse event: Infusion set failure
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Irritation/Inflammation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk
Study: NCT03554603

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 51 at risk

Adverse event: Abnormal Temperature
Serious: no
Organ System: Investigations
Frequency: 8 affected / 51 at risk

Adverse event: Oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 51 at risk

Adverse event: Elevated White Blood Cell Count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 51 at risk

Adverse event: Altered Mental Status
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 51 at risk

Adverse event: Tachypnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 51 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Notes: Positive blood culture during study period
Frequency: 1 affected / 49 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 49 at risk

Adverse event: Abnormal Temperature
Serious: no
Organ System: Investigations
Frequency: 5 affected / 49 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 49 at risk

Adverse event: Elevated White Blood Cell Count
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 49 at risk

Adverse event: Altered Mental Status
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 49 at risk

Adverse event: Tachypnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 49 at risk
Study: NCT03554629

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Low Oxygenation with SpO2 \< 90% via finger pulse Oximeter Supplemental O2 at 5lpm Occurred with Open Mouth Breathing at RR = 24
Frequency: 1 affected / 29 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Low Oxygenation with SpO2 \< 90% via finger pulse Oximeter Supplemental O2 at 5lpm Occurred with Closed Mouth Breathing at RR = 6
Frequency: 1 affected / 29 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Low Oxygenation with SpO2 \< 90% via finger pulse Oximeter Supplemental O2 at 5lpm Occurred with Open Mouth Breathing at RR = 24
Frequency: 1 affected / 29 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Low Oxygenation with SpO2 \< 90% via finger pulse Oximeter Supplemental O2 at 5lpm Occurred with Closed Mouth Breathing at RR = 6
Frequency: 1 affected / 29 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Low Oxygenation with SpO2 \< 90% via finger pulse Oximeter Supplemental O2 at 5lpm Occurred with Open Mouth Breathing at RR = 6
Frequency: 1 affected / 29 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Low Oxygenation with SpO2 \< 90% via finger pulse Oximeter Supplemental O2 at 5lpm Occurred with Open Mouth Breathing at RR = 24
Frequency: 1 affected / 29 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Low Oxygenation with SpO2 \< 90% via finger pulse Oximeter Supplemental O2 at 5lpm Occurred with Open Mouth Breathing at RR = 24
Frequency: 1 affected / 29 at risk
Study: NCT03554772

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 30 at risk

Adverse event: Glomerular filtration rate decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 30 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Alveolar osteitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 30 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 30 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Investigations
Frequency: 1 affected / 30 at risk

Adverse event: Cardiac murmur
Serious: no
Organ System: Investigations
Frequency: 1 affected / 30 at risk

Adverse event: Haematocrit decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 30 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 30 at risk

Adverse event: International Normalized Ratio increaed
Serious: no
Organ System: Investigations
Frequency: 1 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 29 at risk

Adverse event: Alveolar osteitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 29 at risk

Adverse event: Wolff-Parkinson-White syndrome
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 29 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 31 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Coagulopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 31 at risk
Study: NCT03554850

Adverse event: Nervous system disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 201 at risk

Adverse event: Infections and Infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 201 at risk

Adverse event: General disorders and administration site conditions
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 201 at risk

Adverse event: Cardiac disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 201 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 201 at risk
Study: NCT03555266

Adverse event: Bowel complications
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Surgical complications
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 26 at risk

Adverse event: Organ morbidity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Bowel complications
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Organ morbidity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Device dislocation
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 27 at risk
Study: NCT03555396

Adverse event: Hospitalisation
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 64 at risk

Adverse event: Jailed
Serious: no
Organ System: Social circumstances
Frequency: 3 affected / 64 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 68 at risk
Study: NCT03555448

Adverse event: AKI
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 23 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 23 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Nausea and vomiting/abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 23 at risk

Adverse event: Transplant renal artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 23 at risk

Adverse event: Dialysis access issue (clotting/bleeding)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 23 at risk

Adverse event: AKI
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 24 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 24 at risk

Adverse event: Urine leak
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 24 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Nausea and vomiting/abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 24 at risk

Adverse event: Transplant renal artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 24 at risk

Adverse event: Dialysis access issue (clotting/bleeding)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 24 at risk
Study: NCT03555565

Adverse event: Hepatocellular carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1011 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1011 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1011 at risk

Adverse event: Large intestine polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1011 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1011 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1011 at risk

Adverse event: Bundle branch block right
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1011 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1011 at risk

Adverse event: Chronic gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1011 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1011 at risk

Adverse event: Cold sweat
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1011 at risk

Adverse event: Drug eruption
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1011 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1011 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1011 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1011 at risk

Adverse event: Renal disorder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1011 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1011 at risk
Study: NCT03555695

Adverse event: Appendicitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not deemed related to study
Frequency: 1 affected / 19 at risk

Adverse event: Exacerbation of pre-existing sciatica
Serious: no
Organ System: Nervous system disorders
Notes: One participant reported exacerbation of pre-existing sciatica that occurred during study time frame but outside of class
Frequency: 1 affected / 19 at risk
Study: NCT03555890

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 48 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 48 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 48 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 48 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 48 at risk
Study: NCT03555981

Adverse event: Life threatening event
Serious: yes
Organ System: General disorders
Notes: Defined as either apnoea needing resuscitation, severe instability as per protocol definitions or any other life threatening event as assessed by a clinician
Frequency: 13 affected / 138 at risk

Adverse event: Risk of disability
Serious: yes
Organ System: Nervous system disorders
Notes: Any condition placing the neonate at increased risk of permanent or temporary disability, such as suspected meningitis, severe jaundice or acquired hydrocephalus
Frequency: 6 affected / 138 at risk

Adverse event: Hospital re-admission
Serious: yes
Organ System: General disorders
Notes: Re-admission within 28 postnatal days
Frequency: 4 affected / 138 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: Hospitalised for \>28 days
Frequency: 7 affected / 138 at risk

Adverse event: Life threatening event
Serious: yes
Organ System: General disorders
Notes: Defined as either apnoea needing resuscitation, severe instability as per protocol definitions or any other life threatening event as assessed by a clinician
Frequency: 11 affected / 141 at risk

Adverse event: Risk of disability
Serious: yes
Organ System: Nervous system disorders
Notes: Any condition placing the neonate at increased risk of permanent or temporary disability, such as suspected meningitis, severe jaundice or acquired hydrocephalus
Frequency: 7 affected / 141 at risk

Adverse event: Hospital re-admission
Serious: yes
Organ System: General disorders
Notes: Re-admission within 28 postnatal days
Frequency: 5 affected / 141 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: Hospitalised for \>28 days
Frequency: 5 affected / 141 at risk