Trial Outcomes & Findings for Defibrotide for Patients With Hepatic Veno-occlusive Disease: A Treatment IND Study (NCT NCT00628498)
NCT ID: NCT00628498
Last Updated: 2017-11-30
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1206 participants
Primary outcome timeframe
Day +100 from HSCT or 100 days from start of chemotherapy
Results posted on
2017-11-30
Participant Flow
Participant milestones
| Measure |
Defibrotide
Defibrotide 25 mg/kg day given in 4 divided doses approximately every 6 hours
|
|---|---|
|
Overall Study
STARTED
|
1206
|
|
Overall Study
COMPLETED
|
1154
|
|
Overall Study
NOT COMPLETED
|
52
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Defibrotide for Patients With Hepatic Veno-occlusive Disease: A Treatment IND Study
Baseline characteristics by cohort
| Measure |
Defibrotide
n=1154 Participants
Defibrotide 25 mg/kg day given in 4 divided doses approximately every 6 hours
|
|---|---|
|
Age, Continuous
|
19.32 years
STANDARD_DEVIATION 20.004 • n=5 Participants
|
|
Sex: Female, Male
Female
|
503 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
651 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day +100 from HSCT or 100 days from start of chemotherapyPopulation: ITT Efficacy Population
Outcome measures
| Measure |
Defibrotide
n=571 Participants
Defibrotide 25 mg/kg day given in 4 divided doses approximately every 6 hours
|
|---|---|
|
Survival by Day+100 Post Stem Cell Transplant or Chemotherapy
|
49.9 Percentage of participants alive
Interval 45.8 to 54.0
|
Adverse Events
Defibrotide
Serious events: 598 serious events
Other events: 166 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Defibrotide
n=1154 participants at risk
Defibrotide 25 mg/kg day given in 4 divided doses approximately every 6 hours
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.52%
6/1154
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.43%
5/1154
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.43%
5/1154
|
|
Blood and lymphatic system disorders
Anaemia
|
0.17%
2/1154
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.17%
2/1154
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.09%
1/1154
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.09%
1/1154
|
|
Blood and lymphatic system disorders
Histiocytosis haematophagic
|
0.09%
1/1154
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.09%
1/1154
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.09%
1/1154
|
|
Cardiac disorders
Cardiac arrest
|
1.1%
13/1154
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.78%
9/1154
|
|
Cardiac disorders
Atrial flutter
|
0.69%
8/1154
|
|
Cardiac disorders
Pericardial effusion
|
0.69%
8/1154
|
|
Cardiac disorders
Bradycardia
|
0.52%
6/1154
|
|
Cardiac disorders
Atrial fibrillation
|
0.43%
5/1154
|
|
Cardiac disorders
Cardiac failure
|
0.35%
4/1154
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.26%
3/1154
|
|
Cardiac disorders
Sinus bradycardia
|
0.26%
3/1154
|
|
Cardiac disorders
Cardiac tamponade
|
0.17%
2/1154
|
|
Cardiac disorders
Cardiomyopathy
|
0.17%
2/1154
|
|
Cardiac disorders
Acute myocardial infarction
|
0.09%
1/1154
|
|
Cardiac disorders
Atrial thrombosis
|
0.09%
1/1154
|
|
Cardiac disorders
Atrioventricular block complete
|
0.09%
1/1154
|
|
Cardiac disorders
Cardiac failure congestive
|
0.09%
1/1154
|
|
Cardiac disorders
Right ventricular failure
|
0.09%
1/1154
|
|
Cardiac disorders
Torsade de pointes
|
0.09%
1/1154
|
|
Cardiac disorders
Ventricular fibrillation
|
0.09%
1/1154
|
|
Eye disorders
Retinal haemorrhage
|
0.09%
1/1154
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.9%
33/1154
|
|
Gastrointestinal disorders
Diarrhoea
|
0.78%
9/1154
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.69%
8/1154
|
|
Gastrointestinal disorders
Ascites
|
0.61%
7/1154
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.43%
5/1154
|
|
Gastrointestinal disorders
Abdominal pain
|
0.35%
4/1154
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.35%
4/1154
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.35%
4/1154
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.26%
3/1154
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.26%
3/1154
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
0.26%
3/1154
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.26%
3/1154
|
|
Gastrointestinal disorders
Colitis
|
0.17%
2/1154
|
|
Gastrointestinal disorders
Haematemesis
|
0.17%
2/1154
|
|
Gastrointestinal disorders
Abdominal compartment syndrome
|
0.09%
1/1154
|
|
Gastrointestinal disorders
Abdominal distension
|
0.09%
1/1154
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.09%
1/1154
|
|
Gastrointestinal disorders
Enterocolitis
|
0.09%
1/1154
|
|
Gastrointestinal disorders
Haematochezia
|
0.09%
1/1154
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.09%
1/1154
|
|
Gastrointestinal disorders
Malabsorption
|
0.09%
1/1154
|
|
Gastrointestinal disorders
Nausea
|
0.09%
1/1154
|
|
Gastrointestinal disorders
Oesophageal ulcer haemorrhage
|
0.09%
1/1154
|
|
Gastrointestinal disorders
Pancreatitis
|
0.09%
1/1154
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.09%
1/1154
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.09%
1/1154
|
|
Gastrointestinal disorders
Vomiting
|
0.09%
1/1154
|
|
General disorders
Multi-organ failure
|
12.0%
139/1154
|
|
General disorders
Pyrexia
|
0.95%
11/1154
|
|
General disorders
Disease progression
|
0.17%
2/1154
|
|
General disorders
Asthenia
|
0.09%
1/1154
|
|
General disorders
Catheter site haemorrhage
|
0.09%
1/1154
|
|
General disorders
Mucosal haemorrhage
|
0.09%
1/1154
|
|
General disorders
Multi-organ disorder
|
0.09%
1/1154
|
|
General disorders
Oedema
|
0.09%
1/1154
|
|
General disorders
Oedema peripheral
|
0.09%
1/1154
|
|
General disorders
Pneumatosis
|
0.09%
1/1154
|
|
Hepatobiliary disorders
Venoocclusive liver disease
|
7.5%
87/1154
|
|
Hepatobiliary disorders
Hepatic failure
|
1.6%
19/1154
|
|
Hepatobiliary disorders
Cholecystitis
|
0.35%
4/1154
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.26%
3/1154
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.17%
2/1154
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.09%
1/1154
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.09%
1/1154
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.09%
1/1154
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.09%
1/1154
|
|
Hepatobiliary disorders
Hepatorenal failure
|
0.09%
1/1154
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.09%
1/1154
|
|
Hepatobiliary disorders
Liver disorder
|
0.09%
1/1154
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.09%
1/1154
|
|
Immune system disorders
Graft versus host disease
|
1.3%
15/1154
|
|
Immune system disorders
Acute graft versus host disease
|
0.52%
6/1154
|
|
Immune system disorders
Graft versus host disease in intestine
|
0.52%
6/1154
|
|
Immune system disorders
Graft versus host disease in liver
|
0.43%
5/1154
|
|
Immune system disorders
Graft versus host disease in skin
|
0.26%
3/1154
|
|
Immune system disorders
Acute graft versus host disease in intestine
|
0.09%
1/1154
|
|
Immune system disorders
Acute graft versus host disease in liver
|
0.09%
1/1154
|
|
Immune system disorders
Acute graft versus host disease in skin
|
0.09%
1/1154
|
|
Immune system disorders
Engraftment syndrome
|
0.09%
1/1154
|
|
Injury, poisoning and procedural complications
Sepsis
|
2.8%
32/1154
|
|
Infections and infestations
Infection
|
1.5%
17/1154
|
|
Infections and infestations
Pneumonia
|
1.2%
14/1154
|
|
Infections and infestations
Septic shock
|
0.69%
8/1154
|
|
Infections and infestations
Lung infection
|
0.61%
7/1154
|
|
Infections and infestations
Cytomegalovirus infection
|
0.43%
5/1154
|
|
Infections and infestations
Bacteraemia
|
0.35%
4/1154
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.35%
4/1154
|
|
Infections and infestations
BK virus infection
|
0.26%
3/1154
|
|
Infections and infestations
Bacterial sepsis
|
0.26%
3/1154
|
|
Infections and infestations
Device related infection
|
0.26%
3/1154
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.26%
3/1154
|
|
Infections and infestations
Sepsis syndrome
|
0.17%
2/1154
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.17%
2/1154
|
|
Infections and infestations
Staphylococcal infection
|
0.17%
2/1154
|
|
Infections and infestations
Urinary tract infection
|
0.17%
2/1154
|
|
Infections and infestations
Abdominal abscess
|
0.09%
1/1154
|
|
Infections and infestations
Abscess
|
0.09%
1/1154
|
|
Infections and infestations
Acid fast bacilli infection
|
0.09%
1/1154
|
|
Infections and infestations
Adenovirus infection
|
0.09%
1/1154
|
|
Infections and infestations
Appendicitis
|
0.09%
1/1154
|
|
Infections and infestations
Aspergillosis
|
0.09%
1/1154
|
|
Infections and infestations
Burkholderia cepacia complex infection
|
0.09%
1/1154
|
|
Infections and infestations
Candida sepsis
|
0.09%
1/1154
|
|
Infections and infestations
Cerebral fungal infection
|
0.09%
1/1154
|
|
Infections and infestations
Citrobacter sepsis
|
0.09%
1/1154
|
|
Infections and infestations
Clostridium difficile infection
|
0.09%
1/1154
|
|
Infections and infestations
Corona virus infection
|
0.09%
1/1154
|
|
Infections and infestations
Enterobacter bacteraemia
|
0.09%
1/1154
|
|
Infections and infestations
Enterobacter infection
|
0.09%
1/1154
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.09%
1/1154
|
|
Infections and infestations
Enterococcal infection
|
0.09%
1/1154
|
|
Infections and infestations
Enterococcal sepsis
|
0.09%
1/1154
|
|
Infections and infestations
Enterocolitis infectious
|
0.09%
1/1154
|
|
Infections and infestations
Fungal infection
|
0.09%
1/1154
|
|
Infections and infestations
Fungal sepsis
|
0.09%
1/1154
|
|
Infections and infestations
Hepatitis viral
|
0.09%
1/1154
|
|
Infections and infestations
Human herpesvirus 6 infection
|
0.09%
1/1154
|
|
Infections and infestations
Lobar pneumonia
|
0.09%
1/1154
|
|
Infections and infestations
Neutropenic infection
|
0.09%
1/1154
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.09%
1/1154
|
|
Infections and infestations
Pneumonia parainfluenzae viral
|
0.09%
1/1154
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.09%
1/1154
|
|
Infections and infestations
Pseudomonal sepsis
|
0.09%
1/1154
|
|
Infections and infestations
Pseudomonas infection
|
0.09%
1/1154
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.09%
1/1154
|
|
Infections and infestations
Septic embolus
|
0.09%
1/1154
|
|
Infections and infestations
Stenotrophomonas sepsis
|
0.09%
1/1154
|
|
Infections and infestations
Systemic candida
|
0.09%
1/1154
|
|
Infections and infestations
Toxoplasmosis
|
0.09%
1/1154
|
|
Infections and infestations
Varicella
|
0.09%
1/1154
|
|
Infections and infestations
Zygomycosis
|
0.09%
1/1154
|
|
Injury, poisoning and procedural complications
Transplant failure
|
0.43%
5/1154
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.26%
3/1154
|
|
Injury, poisoning and procedural complications
Brain herniation
|
0.17%
2/1154
|
|
Injury, poisoning and procedural complications
Engraft failure
|
0.17%
2/1154
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.17%
2/1154
|
|
Injury, poisoning and procedural complications
Endotracheal intubation complication
|
0.09%
1/1154
|
|
Injury, poisoning and procedural complications
Feeding tube complication
|
0.09%
1/1154
|
|
Injury, poisoning and procedural complications
Hepatic haematoma
|
0.09%
1/1154
|
|
Injury, poisoning and procedural complications
Overdose
|
0.09%
1/1154
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.09%
1/1154
|
|
Injury, poisoning and procedural complications
Postoperative thoracic procedure complication
|
0.09%
1/1154
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.09%
1/1154
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.09%
1/1154
|
|
Injury, poisoning and procedural complications
Tracheal haemorrhage
|
0.09%
1/1154
|
|
Injury, poisoning and procedural complications
Transfusion-related acute lung injury
|
0.09%
1/1154
|
|
Investigations
Urine output decreased
|
0.26%
3/1154
|
|
Investigations
Alanine aminotransferase increased
|
0.17%
2/1154
|
|
Investigations
Aspartate aminotransferase increased
|
0.17%
2/1154
|
|
Investigations
Blood bilirubin increased
|
0.17%
2/1154
|
|
Investigations
Transaminases increased
|
0.17%
2/1154
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.09%
1/1154
|
|
Investigations
Blood creatinine increased
|
0.09%
1/1154
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.09%
1/1154
|
|
Investigations
Human herpes virus 6 serology positive
|
0.09%
1/1154
|
|
Investigations
International normalised ratio increased
|
0.09%
1/1154
|
|
Investigations
Oxygen saturation decreased
|
0.09%
1/1154
|
|
Investigations
Pulse absent
|
0.09%
1/1154
|
|
Investigations
Weight increased
|
0.09%
1/1154
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.52%
6/1154
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.43%
5/1154
|
|
Metabolism and nutrition disorders
Acidosis
|
0.26%
3/1154
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.26%
3/1154
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.26%
3/1154
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.17%
2/1154
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.17%
2/1154
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.17%
2/1154
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.09%
1/1154
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.09%
1/1154
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.09%
1/1154
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.17%
2/1154
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.09%
1/1154
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia recurrent
|
0.35%
4/1154
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Post transplant lymphoproliferative disorder
|
0.17%
2/1154
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.09%
1/1154
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia recurrent
|
0.09%
1/1154
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.09%
1/1154
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Burkitt's lymphoma
|
0.09%
1/1154
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Burkitt's lymphoma recurrent
|
0.09%
1/1154
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia recurrent
|
0.09%
1/1154
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma
|
0.09%
1/1154
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloid leukaemia
|
0.09%
1/1154
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroblastoma recurrent
|
0.09%
1/1154
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Recurrent cancer
|
0.09%
1/1154
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rhabdomyosarcoma
|
0.09%
1/1154
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma
|
0.09%
1/1154
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell lymphoma recurrent
|
0.09%
1/1154
|
|
Nervous system disorders
Encephalopathy
|
0.78%
9/1154
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.52%
6/1154
|
|
Nervous system disorders
Convulsion
|
0.43%
5/1154
|
|
Nervous system disorders
Cerebral ischaemia
|
0.26%
3/1154
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.26%
3/1154
|
|
Nervous system disorders
Hydrocephalus
|
0.26%
3/1154
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.26%
3/1154
|
|
Nervous system disorders
Central nervous system haemorrhage
|
0.17%
2/1154
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.17%
2/1154
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.17%
2/1154
|
|
Nervous system disorders
Autonomic neuropathy
|
0.09%
1/1154
|
|
Nervous system disorders
Brain hypoxia
|
0.09%
1/1154
|
|
Nervous system disorders
Brain injury
|
0.09%
1/1154
|
|
Nervous system disorders
Brain oedema
|
0.09%
1/1154
|
|
Nervous system disorders
Cerebellar haematoma
|
0.09%
1/1154
|
|
Nervous system disorders
Cerebral infarction
|
0.09%
1/1154
|
|
Nervous system disorders
Cerebrovascular accident
|
0.09%
1/1154
|
|
Nervous system disorders
Depressed level of consciousness
|
0.09%
1/1154
|
|
Nervous system disorders
Facial nerve disorder
|
0.09%
1/1154
|
|
Nervous system disorders
Hypertonia
|
0.09%
1/1154
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.09%
1/1154
|
|
Nervous system disorders
Neuropathy peripheral
|
0.09%
1/1154
|
|
Nervous system disorders
Syncope
|
0.09%
1/1154
|
|
Psychiatric disorders
Confusional state
|
0.09%
1/1154
|
|
Psychiatric disorders
Mental status changes
|
0.09%
1/1154
|
|
Psychiatric disorders
Psychotic disorder
|
0.09%
1/1154
|
|
Renal and urinary disorders
Renal failure
|
3.9%
45/1154
|
|
Renal and urinary disorders
Renal failure acute
|
1.9%
22/1154
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.52%
6/1154
|
|
Renal and urinary disorders
Renal impairment
|
0.17%
2/1154
|
|
Renal and urinary disorders
Azotaemia
|
0.09%
1/1154
|
|
Renal and urinary disorders
Haematuria
|
0.09%
1/1154
|
|
Renal and urinary disorders
Urinary retention
|
0.09%
1/1154
|
|
Renal and urinary disorders
Urogenital haemorrhage
|
0.09%
1/1154
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.9%
80/1154
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
4.9%
57/1154
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.7%
31/1154
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.9%
22/1154
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
1.4%
16/1154
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
1.1%
13/1154
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.61%
7/1154
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pneumonia syndrome
|
0.52%
6/1154
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.52%
6/1154
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.43%
5/1154
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.43%
5/1154
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.35%
4/1154
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.35%
4/1154
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.26%
3/1154
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.26%
3/1154
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.17%
2/1154
|
|
Respiratory, thoracic and mediastinal disorders
Diffuse alveolar damage
|
0.17%
2/1154
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.17%
2/1154
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.17%
2/1154
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.17%
2/1154
|
|
Respiratory, thoracic and mediastinal disorders
Alveolar proteinosis
|
0.09%
1/1154
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial haemorrhage
|
0.09%
1/1154
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.09%
1/1154
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.09%
1/1154
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
0.09%
1/1154
|
|
Respiratory, thoracic and mediastinal disorders
Pleural haemorrhage
|
0.09%
1/1154
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.09%
1/1154
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.09%
1/1154
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.09%
1/1154
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.09%
1/1154
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary veno-occlusive disease
|
0.09%
1/1154
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.09%
1/1154
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.09%
1/1154
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.09%
1/1154
|
|
Vascular disorders
Hypotension
|
4.0%
46/1154
|
|
Vascular disorders
Venoocclusive disease
|
0.78%
9/1154
|
|
Vascular disorders
Haemorrhage
|
0.61%
7/1154
|
|
Vascular disorders
Hypertension
|
0.35%
4/1154
|
|
Vascular disorders
Circulatory collapse
|
0.17%
2/1154
|
|
Vascular disorders
Haematoma
|
0.17%
2/1154
|
|
Vascular disorders
Hypovolaemic shock
|
0.17%
2/1154
|
|
Vascular disorders
Capillary leak syndrome
|
0.09%
1/1154
|
|
Vascular disorders
Catheter site haemorrhage
|
0.09%
1/1154
|
|
Vascular disorders
Embolism
|
0.09%
1/1154
|
|
Vascular disorders
Haemorrhagic infarction
|
0.09%
1/1154
|
|
Vascular disorders
Hypertensive crisis
|
0.09%
1/1154
|
|
Vascular disorders
Microangiopathy
|
0.09%
1/1154
|
|
Vascular disorders
Shock
|
0.09%
1/1154
|
Other adverse events
| Measure |
Defibrotide
n=1154 participants at risk
Defibrotide 25 mg/kg day given in 4 divided doses approximately every 6 hours
|
|---|---|
|
Vascular disorders
Hypotension
|
8.1%
93/1154
|
|
Gastrointestinal disorders
Diarrhoea
|
6.1%
70/1154
|
|
Gastrointestinal disorders
Vomiting
|
5.5%
63/1154
|
Additional Information
Associate Director, Clinical Trial Disclosure & Transparency
Jazz Pharmaceuticals
Phone: (215) 832-3750
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place