TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01195662

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 224 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 224 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 225 at risk

Adverse event: Hepatitis E
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 225 at risk

Adverse event: Avulsion fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 225 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 225 at risk

Adverse event: Diverticular perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 225 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 225 at risk

Adverse event: Dyspnoea exertional
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 225 at risk

Adverse event: Lumbar vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 133 at risk
Study: NCT01195675

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 29 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 29 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 28 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 28 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 30 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 29 at risk
Study: NCT01195779

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

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

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

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

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

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

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1 at risk
Study: NCT01195831

Adverse event: Limb crushing injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 118 at risk

Adverse event: Ovarian neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 118 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 118 at risk

Adverse event: Application site warmth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 118 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 118 at risk

Adverse event: Application site pain
Serious: no
Organ System: General disorders
Frequency: 14 affected / 124 at risk

Adverse event: Application site warmth
Serious: no
Organ System: General disorders
Frequency: 13 affected / 124 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 124 at risk
Study: NCT01195922

Adverse event: Injury, procedural complications/post-operative wound complication
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Subject had an active bleed from the original tonsillectomy site intraoperative which necessitated extended intubation to postoperative Day 2 when the subject was successfully extubated without further bleeding or complications.
Frequency: 1 affected / 16 at risk

Adverse event: Injury, procedural complications/postoperative wound complication
Serious: yes
Organ System: Infections and infestations
Notes: Orocutaneous fistula with left leg epidermolysis. Jaw hardware candida infection, surgical flap necrosis/failure.
Frequency: 1 affected / 16 at risk

Adverse event: Cardiac disorder
Serious: yes
Organ System: Cardiac disorders
Notes: Left Bundle Branch Block diagnosed on routine stress test. Subject had left heart catheterization with stent placement.
Frequency: 1 affected / 16 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Thrombocytopenia Neutropenia Anemia Leukopenia
Frequency: 8 affected / 16 at risk

Adverse event: Investigations
Serious: no
Organ System: Investigations
Notes: Combined decreased: neutrophil count, phosphorous, potassium, white blood cell, platelet.

Combined increased: ALT, AST. BUN, glucose, BUN, hepatic enzymes, monocyte count
Frequency: 7 affected / 16 at risk

Adverse event: Gastrointestinal disorders
Serious: no
Organ System: Gastrointestinal disorders
Notes: Combined events reported: vomiting, dysphagia, nausea, oral pain
Frequency: 3 affected / 16 at risk

Adverse event: Nervous system disorders
Serious: no
Organ System: Nervous system disorders
Notes: Combined headache, dizziness, hypogeusia
Frequency: 3 affected / 16 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Combined: oropharyngeal pain, nasal congestion
Frequency: 3 affected / 16 at risk

Adverse event: General Disorders and administration site conditions
Serious: no
Organ System: General disorders
Notes: Combined: mucosal inflammation, pain, pyrexia
Frequency: 2 affected / 16 at risk

Adverse event: Injury, poisoning, and procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Combined: postoperative wound complications and post procedural hemorrhage
Frequency: 2 affected / 16 at risk

Adverse event: Metabolism and nutrition disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Combined: dehydration, hyperglycemia, hypoalbuminaemia
Frequency: 2 affected / 16 at risk

Adverse event: Skin and subcutaneous tissue disorders
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Combined: photosensitivity and rash
Frequency: 2 affected / 16 at risk

Adverse event: Cardiac disorders
Serious: no
Organ System: Cardiac disorders
Notes: Coronary artery disease
Frequency: 1 affected / 16 at risk
Study: NCT01196442

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Notes: Unrelated (Grade 2)
Frequency: 1 affected / 39 at risk
Study: NCT01196819

Adverse event: Death
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 225 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 9 affected / 225 at risk

Adverse event: Coronary revascularisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 28 affected / 225 at risk

Adverse event: Definite/probable in-stent thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 225 at risk

Adverse event: Death
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 227 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 227 at risk

Adverse event: Coronary revascularisation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 16 affected / 227 at risk
Study: NCT01196923

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk
Study: NCT01197495

Adverse event: Development Hip Dysplasia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 208 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 208 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 208 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 208 at risk

Adverse event: Injection site mass
Serious: no
Organ System: General disorders
Frequency: 33 affected / 208 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 21 affected / 208 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 9 affected / 208 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 114 at risk

Adverse event: Premature baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 114 at risk

Adverse event: Injection site mass
Serious: no
Organ System: General disorders
Frequency: 11 affected / 114 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 11 affected / 114 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 114 at risk
Study: NCT01197547

Adverse event: Thermal burn
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 992 at risk

Adverse event: Clinically Non-Significant Burn
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 992 at risk
Study: NCT01197573

Adverse event: Primary non -function
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 33 at risk

Adverse event: Delayed graft function
Serious: no
Organ System: Surgical and medical procedures
Frequency: 12 affected / 33 at risk

Adverse event: Primary non -function
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 46 at risk

Adverse event: Delayed graft function
Serious: no
Organ System: Surgical and medical procedures
Frequency: 8 affected / 46 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 12 at risk

Adverse event: Urinary Leak
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 12 at risk

Adverse event: Delayed graft function
Serious: no
Organ System: Surgical and medical procedures
Frequency: 5 affected / 12 at risk

Adverse event: Necrosis
Serious: yes
Organ System: Surgical and medical procedures
Notes: Necrotic Right Colon
Frequency: 1 affected / 12 at risk

Adverse event: Urinary Leak
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 12 at risk

Adverse event: Delayed graft function
Serious: no
Organ System: Surgical and medical procedures
Frequency: 7 affected / 12 at risk
Study: NCT01197898

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Notes: SAE judged to be not related to test article by the Investigator
Frequency: 1 affected / 5 at risk
Study: NCT01197911

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Nasal decongestion therapy
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 18 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk
Study: NCT01198028

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 39 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 39 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Anemia (grade 3)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 39 at risk

Adverse event: Nausea (grade 3)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Diarrhea (grade 3)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Vomitting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Acneiform rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 39 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 14 affected / 39 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 39 at risk

Adverse event: Oral Mucositis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 39 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 39 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 39 at risk

Adverse event: Watery eyes
Serious: no
Organ System: Eye disorders
Frequency: 10 affected / 39 at risk
Study: NCT01198509

Adverse event: stomach pain/loose stools
Serious: no
Organ System: Gastrointestinal disorders
Notes: Resolved within 24 hours. Possibly related to study treatment. Participant continued treatment and completed study.
Frequency: 1 affected / 10 at risk
Study: NCT01198587

Adverse event: Hospitalization after starting the study protocol within 14 days
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Patients will be assess to identify if the admission is related (for example a motor vehicle accident would be unrelated) and if the reason for admission could be related to the study medication
Frequency: 1 affected / 23 at risk

Adverse event: discontinued due to vomiting/tast
Serious: no
Organ System: Gastrointestinal disorders
Notes: Drug stopped by parent/guardian due to taste or vomiting (difficult to distinguish between the two in young children)
Frequency: 2 affected / 23 at risk

Adverse event: discontinued due to vomiting/tast
Serious: no
Organ System: Gastrointestinal disorders
Notes: Drug stopped by parent/guardian due to taste or vomiting (difficult to distinguish between the two in young children)
Frequency: 2 affected / 21 at risk
Study: NCT01198769

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 15 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 6 affected / 15 at risk

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

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 11 affected / 15 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 10 affected / 15 at risk

Adverse event: Temperature
Serious: no
Organ System: General disorders
Frequency: 5 affected / 15 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 2 affected / 15 at risk
Study: NCT01198795

Adverse event: Mania
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 118 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 118 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 118 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 118 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 6 affected / 118 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 7 affected / 118 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 118 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 118 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 118 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 118 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 10 affected / 118 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 118 at risk
Study: NCT01198873

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 41 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 41 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 41 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 2 affected / 41 at risk

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

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Pancreatic cyst
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Gouty arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 35 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 35 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 35 at risk

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

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

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

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 35 at risk

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

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

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

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 4 affected / 35 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 2 affected / 35 at risk
Study: NCT01199198

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 17 affected / 17 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 17 at risk

Adverse event: Oedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 17 at risk

Adverse event: Infections (any type)
Serious: yes
Organ System: Infections and infestations
Frequency: 13 affected / 17 at risk

Adverse event: Hypotension
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 17 at risk

Adverse event: Worsening of Edema
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 17 at risk