TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00278200

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Pain - abdomen
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Acute lung injury
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Ascites
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 12 at risk

Adverse event: Contusion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Diplopia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hypertension
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 12 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 12 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Pain - unspecified
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Pain - abdomen
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Pain - axilla
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 12 at risk

Adverse event: Umbilical hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 12 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk
Study: NCT00278343

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 74 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 74 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 74 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 74 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 74 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 74 at risk

Adverse event: Small intestinal obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 74 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 74 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 18 affected / 74 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 13 affected / 74 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 74 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 47 affected / 74 at risk
Study: NCT00278395

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 14 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 14 at risk

Adverse event: Fatigue
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 14 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 14 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 14 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 14 at risk
Study: NCT00278512

Adverse event: CMV Hepatitis
Serious: yes
Organ System: Infections and infestations
Notes: One participant died of CMV hepatitis.
Frequency: 1 affected / 7 at risk

Adverse event: Swine flu
Serious: no
Organ System: Infections and infestations
Notes: One patient diagnosed with swine flu, requiring transient face mask oxygen and recovered.
Frequency: 1 affected / 7 at risk

Adverse event: Aspergillus
Serious: no
Organ System: Infections and infestations
Notes: One patient 4 years after transplant relapsed and was started on actemra. After 2 years of actemra ( a TNF inhibitor) patient developed aspergillus
Frequency: 1 affected / 7 at risk

Adverse event: Pseudomonas pneumonia
Serious: no
Organ System: Infections and infestations
Notes: One patient 4 years after transplant relapsed and was started on actemra. After 2 years of actemra ( a TNF inhibitor) patient developed pseudomonas pneumonia.
Frequency: 1 affected / 7 at risk

Adverse event: Intestinal obstruction
Serious: no
Organ System: Gastrointestinal disorders
Notes: Two years after transplant had bowel obstruction due to pre transplant surgical scars-
Frequency: 1 affected / 7 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 7 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 7 at risk
Study: NCT00278525

Adverse event: Positive stool culture for Clostridium difficile
Serious: no
Organ System: Infections and infestations
Notes: During hospitalisation for transplantation, 1 patient had a positive stool culture for Clostridium difficile
Frequency: 1 affected / 17 at risk

Adverse event: Positive blood culture for micrococcus
Serious: no
Organ System: Infections and infestations
Notes: During the hospitalisation for transplantation, 1 patient had a positive blood culture for micrococcus
Frequency: 1 affected / 17 at risk

Adverse event: Supraventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: During hospitalisation for transplantation, one patient developed Supraventricular tachycardia that was controlled with oral medication
Frequency: 1 affected / 17 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Notes: During hospitalisation for transplantation, 1 patient developed Atrial fibrillation that was controlled with oral medication
Frequency: 1 affected / 17 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: Cardiac disorders
Notes: During the hospitalization for transplantation, two patients developed volume overload that were controlled with diuretics
Frequency: 2 affected / 17 at risk

Adverse event: Cytomegalovirus reactivation on surveillance blood test
Serious: no
Organ System: Infections and infestations
Notes: The only one infectious event after hospitalisation for transplantation was a cytomegalovirus reactivation on surveillance blood test in one patent, which was treated with oral valganciclovir.
Frequency: 1 affected / 17 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Notes: One patient in the control group developed cellulitis that was treated with oral antibiotics.
Frequency: 1 affected / 9 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Two patients from the control group needed protracted outpatient treatment for gastroenteritis with nausea, vomiting and diarrhoea
Frequency: 2 affected / 9 at risk
Study: NCT00278538

Adverse event: Elevated Troponin
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 4 Toxicity During HSCT Hospitalization
Frequency: 1 affected / 30 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Grade 4 Toxicity During HSCT Hospitalization
Frequency: 3 affected / 30 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: General disorders
Notes: Grade 4 Toxicity During HSCT Hospitalization
Frequency: 1 affected / 30 at risk

Adverse event: Neutropenic Fevers
Serious: no
Organ System: Infections and infestations
Notes: Grade 3 Toxicity During HSCT Hospitalization
Frequency: 10 affected / 30 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 3 Toxicity During HSCT Hospitalization
Frequency: 8 affected / 30 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Notes: Grade 3 Toxicity During HSCT Hospitalization
Frequency: 7 affected / 30 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 3 Toxicity During HSCT Hospitalization
Frequency: 6 affected / 30 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 3 Toxicity During HSCT Hospitalization
Frequency: 5 affected / 30 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: General disorders
Notes: Grade 3 Toxicity During HSCT Hospitalization
Frequency: 5 affected / 30 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 3 Toxicity During HSCT Hospitalization
Frequency: 3 affected / 30 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Grade 3 Toxicity During HSCT Hospitalization
Frequency: 3 affected / 30 at risk

Adverse event: Elevated Transaminase
Serious: no
Organ System: General disorders
Notes: Grade 3 Toxicity During HSCT Hospitalization
Frequency: 2 affected / 30 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Notes: Grade 3 Toxicity During HSCT Hospitalization
Frequency: 2 affected / 30 at risk
Study: NCT00278564

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Two patients had sinusitis treated with oral antibiotics and IVIG and resolved with treatment.
Frequency: 2 affected / 7 at risk

Adverse event: Viral infection
Serious: no
Organ System: General disorders
Notes: one hospitalization for transient nausea, vomiting and diarrhea-- no documented etiology.
Frequency: 1 affected / 7 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: General disorders
Notes: One patient had transient asymptomatic grade 4 hypokalemia during transplant.
Frequency: 1 affected / 7 at risk
Study: NCT00278629

Adverse event: Total Parenteral Nutrition - due to vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 66 at risk

Adverse event: Transient Dyspnea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 66 at risk

Adverse event: Non Transplant Related Death
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 66 at risk

Adverse event: Non Transplant Related Death
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Gastric Cancer
Frequency: 1 affected / 66 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 29 affected / 66 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: General disorders
Frequency: 26 affected / 66 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 66 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 66 at risk

Adverse event: Infections
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 66 at risk

Adverse event: Clostridium Difficile Diarrhea
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 66 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 66 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 66 at risk
Study: NCT00278655

Adverse event: Transient neurological symptoms
Serious: no
Organ System: Nervous system disorders
Notes: One patient had Transient neurological symptoms that manifested as leftsided hypoaesthesia, which was attributed to a filgrastim-related flair. The neurological symptoms resolved when the drug was discontinued.
Frequency: 1 affected / 21 at risk

Adverse event: Blood culture with coagulase-negative staphylococcus
Serious: no
Organ System: Infections and infestations
Notes: One patient had a blood culture with coagulase-negative staphylococcus; this was isolated in one specimen of four sent concurrently, which suggests a probable contaminant.
Frequency: 1 affected / 21 at risk

Adverse event: Dermatomal zoster
Serious: no
Organ System: Infections and infestations
Notes: Two patients developed dermatomal zoster at 20 and 22 months post-transplantation and both resolved with oral antiviral therapy.
Frequency: 2 affected / 21 at risk

Adverse event: Diarrhoea due to Clostridium difficile
Serious: no
Organ System: Gastrointestinal disorders
Notes: One month after hospital discharge after the transplantation, one patient developed diarrhoea due to Clostridium difficile that resolved with oral metronidazole.
Frequency: 1 affected / 21 at risk

Adverse event: Grade IV thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Two patients treated with alemtuzumab developed grade IV thrombocytopenia 7 and 14 months after transplantation. The thrombocytopenia presented as easy bruising and petechiae, resolved with intravenous immunoglobulin, prednisone and rituximab
Frequency: 2 affected / 21 at risk
Study: NCT00278863

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 37 affected / 42 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 42 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 42 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 42 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 34 affected / 42 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 42 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 42 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 42 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 42 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 42 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 42 at risk

Adverse event: Hand-foot syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 42 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 13 affected / 42 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 39 affected / 44 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 44 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 13 affected / 44 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 44 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 34 affected / 44 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 44 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 44 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 44 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 44 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 44 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 44 at risk

Adverse event: Hand-foot syndrome
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 44 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 44 at risk
Study: NCT00278876

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 40 affected / 47 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 28 affected / 47 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 34 affected / 47 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 47 at risk

Adverse event: Oedema
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 42 affected / 47 at risk

Adverse event: Weight increased
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 47 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 47 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 47 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 47 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 47 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 47 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 47 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 47 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 25 affected / 47 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 47 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 47 at risk

Adverse event: Elevated aspartate aminotransferase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 12 affected / 47 at risk

Adverse event: Elevated alanine transferase
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 13 affected / 47 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 14 affected / 47 at risk

Adverse event: Azotaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 47 at risk
Study: NCT00279214

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 22 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 22 at risk

Adverse event: Right sided hemothorax
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 22 at risk

Adverse event: Hemorrage intraperitoneal
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 22 at risk

Adverse event: Atrial fibrilation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 22 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Gross hematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 22 at risk

Adverse event: Oropharynx blood and ecchymoses
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 21 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 21 at risk
Study: NCT00279812

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

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

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