Trial Outcomes & Findings for Defibrotide for the Treatment of Severe Hepatic Veno-Occlusive Disease in Hematopoetic Stem Cell Transplant Patients (NCT NCT00358501)
NCT ID: NCT00358501
Last Updated: 2017-01-30
Results Overview
The 95.1% CI instead of 95% CI is used for the final analysis to provide a small adjustment for the fact that an interim analysis was performed.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
134 participants
Primary outcome timeframe
Day+100 post hematopoietic stem cell transplant
Results posted on
2017-01-30
Participant Flow
Participant milestones
| Measure |
Defibrotide
Defibrotide treatment
Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days.
|
Historical Control
The control group was selected from the historical medical charts of patients undergoing HSCT.
|
|---|---|---|
|
Overall Study
STARTED
|
102
|
32
|
|
Overall Study
COMPLETED
|
102
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Defibrotide for the Treatment of Severe Hepatic Veno-Occlusive Disease in Hematopoetic Stem Cell Transplant Patients
Baseline characteristics by cohort
| Measure |
Defibrotide
n=102 Participants
Defibrotide treatment
Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days.
|
Historical Control
n=32 Participants
The control group was selected from the historical medical charts of patients undergoing hematopoietic stem cell transplant (HSCT).
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.0 years
STANDARD_DEVIATION 21.37 • n=5 Participants
|
25.1 years
STANDARD_DEVIATION 20.23 • n=7 Participants
|
25.7 years
STANDARD_DEVIATION 21.03 • n=5 Participants
|
|
Age, Customized
≤16 years old
|
44 participants
n=5 Participants
|
14 participants
n=7 Participants
|
58 participants
n=5 Participants
|
|
Age, Customized
>16 years old
|
58 participants
n=5 Participants
|
18 participants
n=7 Participants
|
76 participants
n=5 Participants
|
|
Gender
Female
|
38 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Gender
Male
|
64 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
77 participants
n=5 Participants
|
23 participants
n=7 Participants
|
100 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latino/Latina
|
10 participants
n=5 Participants
|
1 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
6 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
93 participants
n=5 Participants
|
27 participants
n=7 Participants
|
120 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Weight
|
53.7 kg
STANDARD_DEVIATION 33.73 • n=5 Participants
|
52.6 kg
STANDARD_DEVIATION 30.55 • n=7 Participants
|
53.4 kg
STANDARD_DEVIATION 32.89 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day+100 post hematopoietic stem cell transplantPopulation: Intent-to-Treat
The 95.1% CI instead of 95% CI is used for the final analysis to provide a small adjustment for the fact that an interim analysis was performed.
Outcome measures
| Measure |
Defibrotide
n=102 Participants
Defibrotide treatment
Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days.
|
Historical Control
n=32 Participants
The control group was selected from the historical medical charts of patients undergoing HSCT.
|
|---|---|---|
|
Survival at Day+100 Following Hematopoietic Stem Cell Transplant
|
38.2 percentage of participants
Interval 28.8 to 47.7
|
25.0 percentage of participants
Interval 9.9 to 40.1
|
PRIMARY outcome
Timeframe: Day+100 post hematopoietic stem cell transplantPopulation: Intent-to-Treat
The 95.1% CI instead of 95% CI is used for the final analysis to provide a small adjustment for the fact that an interim analysis was performed.
Outcome measures
| Measure |
Defibrotide
n=102 Participants
Defibrotide treatment
Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days.
|
Historical Control
n=32 Participants
The control group was selected from the historical medical charts of patients undergoing HSCT.
|
|---|---|---|
|
Complete Response by Day+100 Post Hematopoietic Stem Cell Transplant
|
25.5 percentage of participants
Interval 17.0 to 34.0
|
12.5 percentage of participants
Interval 1.0 to 24.0
|
SECONDARY outcome
Timeframe: 180 days post hematopoietic stem cell transplantPopulation: Intent-to-Treat
The 95.1% CI instead of 95% CI is used for the final analysis to provide a small adjustment for the fact that an interim analysis was performed.
Outcome measures
| Measure |
Defibrotide
n=102 Participants
Defibrotide treatment
Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days.
|
Historical Control
n=32 Participants
The control group was selected from the historical medical charts of patients undergoing HSCT.
|
|---|---|---|
|
Survival at Day+180 Post Hematopoietic Stem Cell Transplantation
|
32.4 percentage of participants
Interval 23.2 to 41.5
|
25.0 percentage of participants
Interval 9.9 to 40.1
|
SECONDARY outcome
Timeframe: Through 30 days from the last dose of DefibrotidePopulation: Safety population
Outcome measures
| Measure |
Defibrotide
n=102 Participants
Defibrotide treatment
Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days.
|
Historical Control
n=32 Participants
The control group was selected from the historical medical charts of patients undergoing HSCT.
|
|---|---|---|
|
Percentage of Participants With Treatment-Emergent Adverse Events
Overall TEAEs
|
97 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With Treatment-Emergent Adverse Events
TEAEs that led to death
|
64 percentage of participants
|
69 percentage of participants
|
|
Percentage of Participants With Treatment-Emergent Adverse Events
Treatment-emergent hemorrhage event
|
64 percentage of participants
|
75 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Through 30 days from the last dose of DefibrotideHistorical Control group was not assessed for severity
Outcome measures
| Measure |
Defibrotide
n=32 Participants
Defibrotide treatment
Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days.
|
Historical Control
The control group was selected from the historical medical charts of patients undergoing HSCT.
|
|---|---|---|
|
Historical Control Group Adverse Event Information
Ischaemia
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Pallor
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Systolic dysfunction
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Tachyarrhythmia
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Nasopharyngitis
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Ventricular hypokinesia
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Adrenal haemorrhage
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Osteomyelitis chronic
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Pneumonia fungal
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Streptococcal bacteraemia
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Urinary tract infection enterococcal
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Vaginal infection
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Post procedural haemorrhage
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Contusion
|
2 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Laceration
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Periorbital haemorrhage
|
2 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Toxicity to various agents
|
2 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Periorbital contusion
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Endotracheal intubation complication
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Eschar
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Eye contusion
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Scratch
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Wound haemorrhage
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Wound secretion
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Blood urine present
|
2 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Haematocrit decreased
|
2 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Heart rate increased
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Activated partial thromboplastin time prolonged
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Ammonia increased
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Blood urea increased
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Blood urine
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Breath sounds abnormal
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Cardiac murmur
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Haemoglobin decreased
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Occult blood positive
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Prothrombin time prolonged
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Transaminases increased
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Urine output decreased
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Hyperglycaemia
|
4 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Fluid overload
|
5 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Metabolic acidosis
|
4 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Hypovolaemia
|
2 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Acidosis
|
2 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Decreased appetite
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Hypercalcaemia
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Hypernatraemia
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Fluid retention
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Hypervolaemia
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Hypoalbuminaemia
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Lactic acidosis
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Type 2 diabetes mellitus
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Back pain
|
3 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Muscle spasms
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Myalgia
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Groin pain
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Limb discomfort
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Pain in extremity
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Pain in jaw
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Convulsion
|
3 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Tremor
|
4 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Cerebral haemorrhage
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Somnolence
|
2 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Asterixis
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Lethargy
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Mental impairment
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Brain oedema
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Paralysis
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Intercranial pressure increased
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Peripheral nerve palsy
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Agitation
|
9 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Confusional state
|
5 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Anxiety
|
4 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Mental status change
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Insomnia
|
4 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Depression
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Disorientation
|
4 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Paranoia
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Haematuria
|
5 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Cystitis haemorrhagic
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Renal failure
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Bladder spasm
|
3 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Incontinence
|
2 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Anuria
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Azotaemia
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Bladder outlet obstruction
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Chromaturia
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Pollakiuria
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Urinary retention
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Scrotal oedema
|
2 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Oedema genital
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Perineal pain
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Vaginal haemorrhage
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Vulvovaginal erythema
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Epistaxis
|
5 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Pulmonary alveolar haemorrhage
|
5 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Respiratory failure
|
4 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Pleural effusion
|
6 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Cough
|
3 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Rales
|
6 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Dyspnoea
|
5 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Tachypnoea
|
2 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Apnoea
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Atelectasis
|
2 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Nasal flaring
|
3 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Oropharyngeal pain
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Acute respiratory distress syndrome
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Haemothorax
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Pneumonia aspiration
|
2 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Respiratory distress
|
2 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Sputum discoloured
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Wheezing
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Bronchial haemorrhage
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Bronchial secretion retention
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Haemoptysis
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Hyperventilation
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Idiopathic pneumonia syndrome
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Pneumomediastinum
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Pneumonitis
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Pulmonary embolism
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Respiratory acidosis
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Respiratory disorder
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Respiratory tract oedema
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Upper respiratory tract congestion
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Use of accessory respiratory muscles
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Petechiae
|
9 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Rash
|
7 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Blister
|
8 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Decubitus ulcer
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Erythema
|
3 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Pruritus
|
3 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Skin disorder
|
5 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Alopecia
|
5 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Rash erythematous
|
2 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Ecchymosis
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Skin ulcer
|
2 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Blood blister
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Skin exfoliation
|
2 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Dermatitis bullous
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Purpura
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Rash macular
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Generalised erythema
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Hyperhidrosis
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Rash maculo-papular
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Skin discolouration
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Skin hypopigmentation
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Skin necrosis
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Hypotension
|
16 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Capillary leak syndrome
|
2 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Circulatory collapse
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Hypertension
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Hypovolaemic shock
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Shock
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Euthyroid sick syndrome
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Conjunctival haemorrhage
|
3 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Ocular icterus
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Scleral haemorrhage
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Conjunctival hyperaemia
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Dry eye
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Eye discharge
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Eye haemorrhage
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Eye irritation
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Lid sulcus deepened
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Pupils unequal
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Diarrhoea
|
12 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Vomiting
|
8 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Nausea
|
10 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Abdominal pain
|
7 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Constipation
|
5 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Gastrointestinal haemorrhage
|
3 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Haematemesis
|
3 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Lip haemorrhage
|
4 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Mouth haemorrhage
|
3 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Dyspepsia
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Haematochezia
|
3 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Melaena
|
2 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Retching
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Abdominal distension
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Chapped lips
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Gastrointestinal hypomotility
|
2 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Gastrointestinal sounds abnormal
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Upper gastrointestinal haemorrhage
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Abdominal discomfort
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Abdominal tenderness
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Duodenal perforation
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Duodenal ulcer
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Dysphagia
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Epigastric discomfort
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Gastritis
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Lip swelling
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Lower gastrointestinal haemorrhage
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Oesophagitis
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Oral disorder
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Pancreatitis
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Umbilical hernia
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Pyrexia
|
9 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Multi-organ failure
|
3 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Oedema peripheral
|
4 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Generalised oedema
|
8 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Hypothermia
|
5 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Oedema
|
7 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Pain
|
3 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Face oedema
|
3 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Asthenia
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Chills
|
2 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Catheter site erythema
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Irritability
|
2 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Catheter site swelling
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Systemic inflammatory response syndrome
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Thrombosis in device
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Catheter site related reaction
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Extravasation
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Polyserositis
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Venoocclusive liver disease
|
2 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Hepatic failure
|
3 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Jaundice
|
3 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Hepatorenal syndrome
|
2 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Acute hepatic failure
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Cholelithiasis
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Gallbladder disorder
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Hepatomegaly
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Portal vein thrombosis
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Graft versus host disease in skin
|
5 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Graft versus host disease
|
2 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Graft versus host disease in intestine
|
2 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Graft versus host disease in liver
|
3 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Engraftment syndrome
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Hypogammaglobulinaemia
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Sepsis
|
2 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Septic shock
|
2 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Bacteraemia
|
3 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Cytomegalovirus infection
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Pneumonia
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Candida sepsis
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Candidiasis
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Enterococcal infection
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Catheter site infection
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Enterococcal sepsis
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Oral candidiasis
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Sinusitis
|
2 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Staphylococcal bacteraemia
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Bacterial infection
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Clostridium difficile colitis
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Herpes simplex
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Total Number of Participants Affected
|
32 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Coagulopathy
|
5 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Anaemia
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Disseminated intravascular coagulation
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Thrombocytopenia
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Haemorrhagic anaemia
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Tachycardia
|
14 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Bradycardia
|
6 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Cardiac arrest
|
2 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Atrial fibrillation
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Cardiac failure congestive
|
2 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Sinus tachycardia
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Cardio-respiratory arrest
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Ventricular tachycardia
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Acute myocardial infarction
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Cardiac failure
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Cardiac tamponade
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Dilatation ventricular
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Pericarditis uraemic
|
1 Number of patients
|
—
|
|
Historical Control Group Adverse Event Information
Supraventricular tachycardia
|
1 Number of patients
|
—
|
Adverse Events
Defibrotide
Serious events: 80 serious events
Other events: 91 other events
Deaths: 0 deaths
Historical Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Defibrotide
n=102 participants at risk
Defibrotide treatment
Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days.
|
Historical Control
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
2.0%
2/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Infections and infestations
Adenovirus infection
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Infections and infestations
Cellulitis
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Infections and infestations
Enterobacter sepsis
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenia purpura
|
2.9%
3/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
3.9%
4/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
General disorders
Multi-organ failure
|
14.7%
15/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Hepatobiliary disorders
Venoocclusive liver disease
|
9.8%
10/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Hepatobiliary disorders
Hepatic failure
|
2.9%
3/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Infections and infestations
Sepsis
|
5.9%
6/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Infections and infestations
Septic shock
|
2.9%
3/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Nervous system disorders
Intracranial hemorrhage
|
3.9%
4/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Nervous system disorders
Cerebral hemorrhage
|
2.9%
3/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Renal and urinary disorders
Renal failure
|
3.9%
4/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
10.8%
11/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar hemorrhage
|
9.8%
10/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hemorrhage
|
4.9%
5/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Vascular disorders
Hypotension
|
13.7%
14/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
2.0%
2/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Cardiac disorders
Cardiac arrest
|
2.0%
2/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Cardiac disorders
Arrhythmia
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Cardiac disorders
Bradycardia
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Cardiac disorders
Myocardial infarction
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Cardiac disorders
Pericardial effusion
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Congenital, familial and genetic disorders
Tay-Sachs disease
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Gastrointestinal disorders
Colitis
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Gastrointestinal disorders
Haematochezia
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Gastrointestinal disorders
Melaena
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
General disorders
Catheter site haemorrhage
|
2.0%
2/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
General disorders
Puncture site haemorrhage
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
General disorders
Pyrexia
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
General disorders
Systematic inflammatory response syndrome
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Hepatobiliary disorders
Hepatorenal failure
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Hepatobiliary disorders
Liver disease
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Immune system disorders
Graft versus host disease
|
2.0%
2/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Immune system disorders
Graft versus host disease in skin
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Infections and infestations
Candida sepsis
|
2.0%
2/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Infections and infestations
Enterococcal infection
|
2.0%
2/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Infections and infestations
Infection
|
2.0%
2/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Infections and infestations
Enterococcal sepsis
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Infections and infestations
Peritonitis
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Infections and infestations
Staphylococcal infection
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Investigations
Human herpes virus 6 serology
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Investigations
Oxygen saturation decreased
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia recurrent
|
2.0%
2/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia recurrent
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia recurrent
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Nervous system disorders
Convulsion
|
2.0%
2/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Nervous system disorders
Encephalopathy
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Nervous system disorders
Nervous system disorder
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Nervous system disorders
Somnolence
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Nervous system disorders
Syncope
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Psychiatric disorders
Psychotic disorder
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Renal and urinary disorders
Renal impairment
|
2.0%
2/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Reproductive system and breast disorders
Pelvic haemorrhage
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
2.0%
2/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Thoracic haemorrhage
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Vascular disorders
Haemorrhage
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Vascular disorders
Ischaemia
|
0.98%
1/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
Other adverse events
| Measure |
Defibrotide
n=102 participants at risk
Defibrotide treatment
Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days.
|
Historical Control
|
|---|---|---|
|
Vascular disorders
Hypotension
|
30.4%
31/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Gastrointestinal disorders
Diarrhea
|
23.5%
24/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Gastrointestinal disorders
Vomiting
|
19.6%
20/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.7%
13/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Gastrointestinal disorders
Nausea
|
12.7%
13/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
General disorders
Pyrexia
|
13.7%
14/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Cardiac disorders
Bradycardia
|
8.8%
9/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
9.8%
10/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Renal and urinary disorders
Haematuria
|
9.8%
10/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Cardiac disorders
Tachycardia
|
9.8%
10/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
General disorders
Catheter site hemorrhage
|
6.9%
7/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Eye disorders
Conjunctival hemorrhage
|
7.8%
8/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.9%
7/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
General disorders
Generalized edema
|
7.8%
8/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.8%
8/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Psychiatric disorders
Mental status change
|
6.9%
7/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Injury, poisoning and procedural complications
Post-procedural hemorrhage
|
5.9%
6/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Blister
|
5.9%
6/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Gastrointestinal disorders
Constipation
|
5.9%
6/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Nervous system disorders
Headache
|
5.9%
6/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
5.9%
6/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
General disorders
Oedema peripheral
|
12.7%
13/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
|
Psychiatric disorders
Agitation
|
10.8%
11/102
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
—
0/0
All adverse events data for Historical Control is provided as an Outcome Measure. Historical Control group summary adverse event information is only available without severity and therefore indicated as 0 at risk in the adverse event tables.
|
Additional Information
Head of Clinical Development
Jazz Pharmaceuticals
Phone: 650.496.3777
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place