TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00505934

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 19 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 19 at risk

Adverse event: Abdominal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 19 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 19 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk

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

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 19 at risk

Adverse event: Eye swelling
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 19 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 19 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Puncture site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 19 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 19 at risk

Adverse event: Electroencephalogram
Serious: no
Organ System: Investigations
Frequency: 1 affected / 19 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Drooling
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Myoclonic epilepsy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 19 at risk

Adverse event: Restlessness
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 19 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 19 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Neurodermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 19 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 19 at risk
Study: NCT00506155

Adverse event: Neutropenia/neutropenic fever
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 60 at risk

Adverse event: Neutropenia/neutropenic fever
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 60 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 7 affected / 60 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 60 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 60 at risk

Adverse event: Thrombosis/pulmonary embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 60 at risk

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

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 60 at risk

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

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hypertransaminasaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 60 at risk

Adverse event: Myocardial ischaemia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk
Study: NCT00506285

Adverse event: insomnia/sleep
Serious: no
Organ System: General disorders
Frequency: 19 affected / 61 at risk

Adverse event: dry eyes, nose, mouth
Serious: no
Organ System: General disorders
Frequency: 8 affected / 61 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 8 affected / 61 at risk

Adverse event: Anxiety
Serious: no
Organ System: General disorders
Frequency: 7 affected / 61 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 61 at risk

Adverse event: anger/irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 61 at risk

Adverse event: insomnia/sleep
Serious: no
Organ System: General disorders
Frequency: 4 affected / 58 at risk

Adverse event: dry eyes, nose, mouth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 58 at risk

Adverse event: Anxiety
Serious: no
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 58 at risk

Adverse event: anger/irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 58 at risk
Study: NCT00506389

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 139 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 139 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 138 at risk

Adverse event: Pneumonia streptococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 138 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 138 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 138 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 138 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 136 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 136 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 139 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 138 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 136 at risk
Study: NCT00506597

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 33 at risk

Adverse event: White Blood Count Decreased
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Cardiopulmonary failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 33 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 33 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Fever/Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 33 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Parathesia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Facial paresis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 33 at risk

Adverse event: Prothrombin time (PTT) increased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Pancreatitis
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 33 at risk

Adverse event: Pancytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 33 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 33 at risk
Study: NCT00506662

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 38 at risk

Adverse event: Barrett's oesophagus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Hiatus hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 38 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 38 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 38 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 38 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 38 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 38 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 48 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 48 at risk

Adverse event: Campylobacter gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Streptococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 48 at risk

Adverse event: Brain neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 48 at risk

Adverse event: Breast cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 48 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 48 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 48 at risk

Adverse event: Disorientation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 48 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 48 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 48 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 48 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 48 at risk
Study: NCT00506675

Adverse event: Light sensitivity
Serious: no
Organ System: General disorders
Frequency: 6 affected / 27 at risk
Study: NCT00506831

Adverse event: Death
Serious: yes
Organ System: Infections and infestations
Notes: Patient experienced pneumonia, was found to be neutropenic, and died of sepsis prior to week 8 assessment.
Frequency: 1 affected / 9 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: 7 patients (78%) experienced infections throughout study:
Frequency: 7 affected / 9 at risk

Adverse event: Oedema
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 9 at risk

Adverse event: gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 9 at risk

Adverse event: new digital ulcers
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 9 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 9 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 9 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: oral ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 9 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 9 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Keratitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 9 at risk
Study: NCT00506857

Adverse event: Transplant failure
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 80 at risk

Adverse event: Infections
Serious: yes
Organ System: Infections and infestations
Frequency: 12 affected / 80 at risk

Adverse event: Pulmonary alveolar haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 80 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 80 at risk

Adverse event: Chronic graft versus host disease
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 73 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 80 at risk

Adverse event: Acute graft versus host disease
Serious: yes
Organ System: General disorders
Frequency: 26 affected / 73 at risk

Adverse event: Elevated alanine aminotransferase
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 80 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 80 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 80 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 39 affected / 80 at risk

Adverse event: Elevated Creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 32 affected / 80 at risk

Adverse event: Cystitis haemorrhagic
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 80 at risk

Adverse event: Elevated alkaline phosphate
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 80 at risk

Adverse event: Altered mental status
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 80 at risk

Adverse event: Occular
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 80 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 80 at risk

Adverse event: Lethargy
Serious: no
Organ System: General disorders
Frequency: 3 affected / 80 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 80 at risk

Adverse event: Stomatitis/Esophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 80 at risk

Adverse event: Hepatotoxicity
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 15 affected / 80 at risk

Adverse event: Elevated alanine aminotransferase
Serious: no
Organ System: Hepatobiliary disorders
Notes: Diarrhea
Frequency: 27 affected / 80 at risk
Study: NCT00506948

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Two deaths related to cases of veno-occlusive disease of the liver.
Frequency: 4 affected / 10 at risk

Adverse event: Veno-occlusive disease of the liver
Serious: yes
Organ System: Renal and urinary disorders
Notes: Two of the four cases were fatal.
Frequency: 4 affected / 10 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 2 affected / 10 at risk

Adverse event: Cystitis haemorrhagic
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Veno-occlusive disease of the liver (Moderate)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 10 at risk

Adverse event: Skin GVHD
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 10 at risk

Adverse event: Gastrointestinal GVHD
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 10 at risk

Adverse event: Acute GVHD
Serious: no
Organ System: General disorders
Notes: Liver, skin (rash), mucosa, and gastrointestinal tract.
Frequency: 2 affected / 10 at risk
Study: NCT00507208

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

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

Adverse event: upper GI bleed
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: facial cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 27 at risk

Adverse event: Arterial injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 27 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 27 at risk

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

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

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

Adverse event: debulking of scar tissue
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 27 at risk

Adverse event: mandibular debridement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 27 at risk

Adverse event: disease recurrence resulting in death
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 27 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 27 at risk

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

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: disease recurrence resulting in death
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 26 at risk

Adverse event: planned procedures prior to radiation tx
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 26 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 26 at risk