TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01910441

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 48 at risk

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

Adverse event: Restlessness
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 47 at risk

Adverse event: Hyperhidrosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 47 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 47 at risk
Study: NCT01910519

Adverse event: Missed abortion (unrelated to study vaccine)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Missed abortion
Frequency: 1 affected / 35 at risk

Adverse event: Body ache
Serious: no
Organ System: General disorders
Frequency: 13 affected / 35 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 35 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 35 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 35 at risk

Adverse event: Upper Respiratory Infections
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 35 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 35 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 3 affected / 35 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Body ache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 15 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 15 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 15 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 3 affected / 15 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk
Study: NCT01910636

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 153 at risk

Adverse event: Allergy to arthropod sting
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 153 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 153 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 11 affected / 153 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 45 affected / 153 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 153 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 153 at risk
Study: NCT01910688

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 25 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 25 at risk

Adverse event: Mucosal haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 25 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 25 at risk

Adverse event: Vomiting, Nausea
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 25 at risk

Adverse event: Abdominal tenderness. Oesophageal pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 25 at risk

Adverse event: Fatigue
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 25 at risk
Study: NCT01911065

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Resolved without sequelae
Frequency: 2 affected / 45 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Herpes zoster developed 1 day following immunization; lesion isolate sent to CDC and was wild-type (not vaccine strain), resolved after prolonged PHN despite prompt antiviral treatment. VAERS report filed.
Frequency: 1 affected / 45 at risk
Study: NCT01911169

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Notes: one subject who had repletion of vitamin D developed hypotension on her regular anti-hypertensive medication and had to be taken off of anti-hypertensive therapy.
Frequency: 1 affected / 6 at risk
Study: NCT01911221

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 13 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 13 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 10 affected / 13 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 5 affected / 13 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 13 affected / 13 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 5 affected / 13 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 13 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 13 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 13 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 13 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 13 at risk
Study: NCT01911260

Adverse event: Gastrointestinal event
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 50 at risk

Adverse event: Gastrointestinal event
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 49 at risk
Study: NCT01911273

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

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1 at risk
Study: NCT01911351

Adverse event: Hallucination
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 43 at risk

Adverse event: Vomiting
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 43 at risk
Study: NCT01911546

Adverse event: Oedema
Serious: yes
Organ System: Renal and urinary disorders
Notes: Swelling was seen in patient one month post transplant
Frequency: 1 affected / 20 at risk

Adverse event: Urine Leak
Serious: yes
Organ System: Renal and urinary disorders
Notes: Urine leak occurred 2 weeks and 1 month post transplant
Frequency: 2 affected / 20 at risk

Adverse event: Antibody Mediated Rejection and Thrombotic Microangiopathy
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

Adverse event: Antibody Mediated Rejection / FSGS /Small Bowel Obstruction/Dehydration
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: Shortness of Breath and Atrial Fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 20 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 20 at risk

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

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 20 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 20 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 20 at risk

Adverse event: General pain
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 20 at risk
Study: NCT01911780

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 68 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 68 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 64 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 65 at risk

Adverse event: Spinal fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 65 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 65 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 65 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 65 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 65 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 65 at risk

Adverse event: Large intestine polyp
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 61 at risk

Adverse event: Lacunar infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 61 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 61 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 61 at risk
Study: NCT01911819

Adverse event: Maxillary sinus infection
Serious: no
Organ System: Infections and infestations
Notes: An acute sinus infection was noted in one sinus in the group of sinus augmentation using Bio-Oss. The graft materials were removed. maxillary sinus compartment was cleaned, irrigated and the area was sutured after the sinus graft procedure.
Frequency: 1 affected / 11 at risk
Study: NCT01911897

Adverse event: Hypertensive emergency
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 30 at risk

Adverse event: Hypotension - chronic
Serious: yes
Organ System: Cardiac disorders
Notes: Chronic = more than 30 days post procedure
Frequency: 2 affected / 30 at risk

Adverse event: Relative hypotension - acute
Serious: yes
Organ System: Cardiac disorders
Notes: Acute = 1-7 days post procedure
Frequency: 1 affected / 30 at risk

Adverse event: Stroke with permanent symptoms
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 30 at risk

Adverse event: Access site complications
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Access site complications
Serious: no
Organ System: General disorders
Frequency: 5 affected / 30 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 6 affected / 30 at risk

Adverse event: Hypotension - acute
Serious: no
Organ System: Cardiac disorders
Notes: Acute = 1-7 days post procedure
Frequency: 2 affected / 30 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 8 affected / 30 at risk

Adverse event: Relative hypotension - acute
Serious: no
Organ System: Cardiac disorders
Notes: Acute = 1-7 days post procedure
Frequency: 2 affected / 30 at risk

Adverse event: Skin sensation disturbance
Serious: no
Organ System: General disorders
Frequency: 3 affected / 30 at risk

Adverse event: Transient ischaemic attack
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk
Study: NCT01912352

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 83 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 83 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 83 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 83 at risk

Adverse event: Fatigue
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 83 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 83 at risk

Adverse event: Trouble sleeping
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 83 at risk

Adverse event: Onychophagia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 83 at risk

Adverse event: Proness to crying
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 83 at risk

Adverse event: Tic
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 83 at risk

Adverse event: Depressive mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 83 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 83 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 83 at risk
Study: NCT01912495

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: One myocardial infarction in a patient with a high-grade left anterior descending artery stenosis that was stented uneventfully (hemoglobin (Hb) 8∙7 mmol/L at the time of the infarction).
Frequency: 1 affected / 57 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Vascular disorders
Notes: One suspected transient ischemic attack that resolved spontaneously and with normal MRI findings (Hb 6∙6 mmol/L)
Frequency: 1 affected / 57 at risk

Adverse event: Anaemia
Serious: yes
Organ System: General disorders
Notes: One anemia (Hb 5·1 mmol/L) for which a transfusion was given and the ribavirin dose was decreased.
Frequency: 1 affected / 57 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Grade 1 anemia was observed in 83%
Frequency: 47 affected / 57 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: grade 2 anemia was observed in 12%
Frequency: 7 affected / 57 at risk
Study: NCT01912599

Adverse event: Corneal Changes
Serious: no
Organ System: Eye disorders
Notes: Includes Epithelial Disruption, corneal edema, and Descemet's folds.
Frequency: 6 affected / 20 at risk

Adverse event: Conjunctival Changes
Serious: no
Organ System: Eye disorders
Notes: Chemosis and conjunctival disruption.
Frequency: 1 affected / 20 at risk

Adverse event: Corneal Changes
Serious: no
Organ System: Eye disorders
Notes: Includes Epithelial Disruption, corneal edema, and Descemet's folds.
Frequency: 3 affected / 16 at risk

Adverse event: Conjunctival Changes
Serious: no
Organ System: Eye disorders
Notes: Chemosis and conjunctival disruption.
Frequency: 3 affected / 16 at risk

Adverse event: Cuff Abrasion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Arm had an abrasion due to blood pressure cuff.
Frequency: 1 affected / 16 at risk
Study: NCT01912612

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 35 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 35 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 35 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 35 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 35 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 35 at risk
Study: NCT01912716

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: requiring hospitalization. Definition of post-ERCP pancreatitis was according to established consensus criteria (Cotton et al., Gastrointestinal Endoscopy 1991;37:383-93).
Frequency: 76 affected / 515 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: as per consensus criteria (as noted for pancreatitis definition)
Frequency: 6 affected / 515 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 515 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: requiring hospitalization. Definition of post-ERCP pancreatitis was according to established consensus criteria (Cotton et al., Gastrointestinal Endoscopy 1991;37:383-93).
Frequency: 65 affected / 522 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: as per consensus criteria (as noted for pancreatitis definition)
Frequency: 8 affected / 522 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: increase in baseline serum creatinine, to greater than 1.4
Frequency: 3 affected / 522 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 522 at risk
Study: NCT01912768

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 238 at risk
Study: NCT01912950

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 11 at risk

Adverse event: Oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk
Study: NCT01913314

Adverse event: Vessel puncture site haematoma
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Vessel puncture site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Vessel puncture site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 6 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Choking
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk
Study: NCT01913340

Adverse event: Cardiopulmonary collapse within 2h of drug
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Thrombosis of major vessel
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Death during birth hospitalization
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 24 at risk

Adverse event: Liver dysfunction (ALT >100 IU/L)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 10 affected / 24 at risk

Adverse event: Hypotension (requiring inotrope or vasopressor)
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 24 at risk

Adverse event: Thrombocytopenia (platelet < 100,000 per uL)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 24 at risk

Adverse event: Persistent pulmonary hypertension
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 24 at risk

Adverse event: Disseminated intravascular coagulation
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 24 at risk

Adverse event: Renal dysfunction (creatinine >1.5)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 24 at risk

Adverse event: Hypertension (requiring anti-hypertensive)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 24 at risk

Adverse event: Thrombosis of major vessel
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Death during birth hospitalization
Serious: yes
Organ System: General disorders
Frequency: 5 affected / 26 at risk

Adverse event: Liver dysfunction (ALT >100 IU/L)
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 6 affected / 26 at risk

Adverse event: Hypotension (requiring inotrope or vasopressor)
Serious: no
Organ System: Vascular disorders
Frequency: 12 affected / 26 at risk

Adverse event: Thrombocytopenia (platelet < 100,000 per uL)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 26 at risk

Adverse event: Persistent pulmonary hypertension
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 26 at risk

Adverse event: Disseminated intravascular coagulation
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 26 at risk

Adverse event: Sepsis (positive blood culture and antibiotics >=7)
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 26 at risk

Adverse event: Renal dysfunction (creatinine >1.5)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 26 at risk