Trial Outcomes & Findings for Pentostatin in Treating Patients With Refractory Chronic Graft-Versus-Host Disease (NCT NCT00074035)
NCT ID: NCT00074035
Last Updated: 2021-11-03
Results Overview
Percentage of participants who had a complete or partial response defined by the Hopkins scoring system. A complete response is defined as the disappearance of signs and symptoms of chronic GVHD in all involved systems that is sustained for at lest 4 weeks. A partial response is an improvement by 2 or more points in at least one system score, which is sustained for at least 4 weeks, with no signs of worsening in others.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
3 months
Results posted on
2021-11-03
Participant Flow
Between December 2003 and March 2008, 39 participants were recruited to this study.
1 participant cancelled prior to receiving treatment and is excluded from all analyses.
Participant milestones
| Measure |
Pentostatin
pentostatin: 4 mg/m\^2 IV infusion over 20-30 min q 2 weeks
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pentostatin in Treating Patients With Refractory Chronic Graft-Versus-Host Disease
Baseline characteristics by cohort
| Measure |
Pentostatin
n=38 Participants
pentostatin: 4 mg/m\^2 IV infusion over 20-30 min q 2 weeks
|
|---|---|
|
Age, Continuous
|
48 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 count of participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 3 patients died before the 3 month evaluation and were not evaluated for the primary endpoint
Percentage of participants who had a complete or partial response defined by the Hopkins scoring system. A complete response is defined as the disappearance of signs and symptoms of chronic GVHD in all involved systems that is sustained for at lest 4 weeks. A partial response is an improvement by 2 or more points in at least one system score, which is sustained for at least 4 weeks, with no signs of worsening in others.
Outcome measures
| Measure |
Pentostatin
n=35 Participants
pentostatin: 4 mg/m\^2 IV infusion over 20-30 min q 2 weeks
|
|---|---|
|
Response Rate
|
20 percentage of participants
|
SECONDARY outcome
Timeframe: Duration of treatment (up to 5 years)Number of participants experiencing a grade 3, 4 or 5 clinically significant non-hematologic adverse events, at least possibly related to treatment.
Outcome measures
| Measure |
Pentostatin
n=38 Participants
pentostatin: 4 mg/m\^2 IV infusion over 20-30 min q 2 weeks
|
|---|---|
|
Grade 3 or Higher Non-hematologic Adverse Events
Fatigue
|
3 count of participants
|
|
Grade 3 or Higher Non-hematologic Adverse Events
Renal failure
|
4 count of participants
|
|
Grade 3 or Higher Non-hematologic Adverse Events
Anorexia
|
2 count of participants
|
|
Grade 3 or Higher Non-hematologic Adverse Events
Infection
|
10 count of participants
|
|
Grade 3 or Higher Non-hematologic Adverse Events
CNS hemmorrhage
|
1 count of participants
|
|
Grade 3 or Higher Non-hematologic Adverse Events
Rash
|
1 count of participants
|
|
Grade 3 or Higher Non-hematologic Adverse Events
Personality/behavioral
|
1 count of participants
|
|
Grade 3 or Higher Non-hematologic Adverse Events
Pneumonitis
|
1 count of participants
|
SECONDARY outcome
Timeframe: 1 yearPercentage of patients who were alive at 1 year.
Outcome measures
| Measure |
Pentostatin
n=38 Participants
pentostatin: 4 mg/m\^2 IV infusion over 20-30 min q 2 weeks
|
|---|---|
|
Overall Survival At 1 Year
|
53 percentage of participants
|
SECONDARY outcome
Timeframe: 2 yearPercentage of patients who were alive at 2 years.
Outcome measures
| Measure |
Pentostatin
n=38 Participants
pentostatin: 4 mg/m\^2 IV infusion over 20-30 min q 2 weeks
|
|---|---|
|
Overall Survival At 2 Years
|
50 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsThe individual PK parameters will be derived by using a noncompartmental analysis of the plasma-concentration-time data
Outcome measures
Outcome data not reported
Adverse Events
Pentostatin
Serious events: 14 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pentostatin
n=34 participants at risk
pentostatin: 4 mg/m\^2 IV infusion over 20-30 min q 2 weeks
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
32.4%
11/34 • Number of events 16
34 participants were evaluable for adverse events
|
|
Cardiac disorders
Atrial tachycardia
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Cardiac disorders
Cardiac disorder
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Cardiac disorders
Edema
|
2.9%
1/34 • Number of events 2
34 participants were evaluable for adverse events
|
|
Cardiac disorders
Sinus tachycardia
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Eye disorders
Dry eye syndrome
|
11.8%
4/34 • Number of events 8
34 participants were evaluable for adverse events
|
|
Eye disorders
Eye disorder
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Eye disorders
Eye pain
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Eye disorders
Photophobia
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Gastrointestinal disorders
Constipation
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Gastrointestinal disorders
Diarrhea
|
17.6%
6/34 • Number of events 8
34 participants were evaluable for adverse events
|
|
Gastrointestinal disorders
Dry mouth
|
11.8%
4/34 • Number of events 5
34 participants were evaluable for adverse events
|
|
Gastrointestinal disorders
Dysphagia
|
2.9%
1/34 • Number of events 2
34 participants were evaluable for adverse events
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
5.9%
2/34 • Number of events 2
34 participants were evaluable for adverse events
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Gastrointestinal disorders
Nausea
|
8.8%
3/34 • Number of events 3
34 participants were evaluable for adverse events
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
2/34 • Number of events 2
34 participants were evaluable for adverse events
|
|
General disorders
Chills
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
General disorders
Edema limbs
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
General disorders
Fatigue
|
8.8%
3/34 • Number of events 4
34 participants were evaluable for adverse events
|
|
General disorders
Fever
|
5.9%
2/34 • Number of events 2
34 participants were evaluable for adverse events
|
|
General disorders
General symptom
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
General disorders
Injection site reaction
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
General disorders
Localized edema
|
5.9%
2/34 • Number of events 2
34 participants were evaluable for adverse events
|
|
General disorders
Pain
|
8.8%
3/34 • Number of events 3
34 participants were evaluable for adverse events
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
2.9%
1/34 • Number of events 4
34 participants were evaluable for adverse events
|
|
Immune system disorders
Immune system disorder
|
2.9%
1/34 • Number of events 2
34 participants were evaluable for adverse events
|
|
Infections and infestations
Catheter related infection
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Infections and infestations
Infection without neutropenia
|
8.8%
3/34 • Number of events 4
34 participants were evaluable for adverse events
|
|
Infections and infestations
Opportunistic infection
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Infections and infestations
Phlebitis infective
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Infections and infestations
Sinusitis
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Investigations
Alanine aminotransferase increased
|
26.5%
9/34 • Number of events 15
34 participants were evaluable for adverse events
|
|
Investigations
Alkaline phosphatase
|
11.8%
4/34 • Number of events 8
34 participants were evaluable for adverse events
|
|
Investigations
Alkaline phosphatase increased
|
14.7%
5/34 • Number of events 7
34 participants were evaluable for adverse events
|
|
Investigations
Aspartate aminotransferase increased
|
32.4%
11/34 • Number of events 17
34 participants were evaluable for adverse events
|
|
Investigations
Blood bilirubin increased
|
20.6%
7/34 • Number of events 11
34 participants were evaluable for adverse events
|
|
Investigations
Coagulopathy
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Investigations
Creatinine increased
|
23.5%
8/34 • Number of events 12
34 participants were evaluable for adverse events
|
|
Investigations
Laboratory test abnormal
|
11.8%
4/34 • Number of events 7
34 participants were evaluable for adverse events
|
|
Investigations
Leukocyte count decreased
|
20.6%
7/34 • Number of events 11
34 participants were evaluable for adverse events
|
|
Investigations
Lymphocyte count decreased
|
5.9%
2/34 • Number of events 3
34 participants were evaluable for adverse events
|
|
Investigations
Neutrophil count decreased
|
14.7%
5/34 • Number of events 5
34 participants were evaluable for adverse events
|
|
Investigations
Platelet count decreased
|
23.5%
8/34 • Number of events 11
34 participants were evaluable for adverse events
|
|
Investigations
Serum cholesterol increased
|
5.9%
2/34 • Number of events 2
34 participants were evaluable for adverse events
|
|
Investigations
Weight loss
|
5.9%
2/34 • Number of events 5
34 participants were evaluable for adverse events
|
|
Metabolism and nutrition disorders
Anorexia
|
11.8%
4/34 • Number of events 5
34 participants were evaluable for adverse events
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
8.8%
3/34 • Number of events 6
34 participants were evaluable for adverse events
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
20.6%
7/34 • Number of events 8
34 participants were evaluable for adverse events
|
|
Metabolism and nutrition disorders
Dehydration
|
14.7%
5/34 • Number of events 7
34 participants were evaluable for adverse events
|
|
Metabolism and nutrition disorders
Iron overload
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
20.6%
7/34 • Number of events 9
34 participants were evaluable for adverse events
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
20.6%
7/34 • Number of events 9
34 participants were evaluable for adverse events
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
11.8%
4/34 • Number of events 7
34 participants were evaluable for adverse events
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
5.9%
2/34 • Number of events 3
34 participants were evaluable for adverse events
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
5.9%
2/34 • Number of events 4
34 participants were evaluable for adverse events
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
8.8%
3/34 • Number of events 3
34 participants were evaluable for adverse events
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
17.6%
6/34 • Number of events 10
34 participants were evaluable for adverse events
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
5.9%
2/34 • Number of events 4
34 participants were evaluable for adverse events
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
5.9%
2/34 • Number of events 4
34 participants were evaluable for adverse events
|
|
Nervous system disorders
Dizziness
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Nervous system disorders
Headache
|
8.8%
3/34 • Number of events 3
34 participants were evaluable for adverse events
|
|
Nervous system disorders
Intracranial hemorrhage
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Nervous system disorders
Tremor
|
5.9%
2/34 • Number of events 2
34 participants were evaluable for adverse events
|
|
Psychiatric disorders
Anxiety
|
5.9%
2/34 • Number of events 2
34 participants were evaluable for adverse events
|
|
Psychiatric disorders
Confusion
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Psychiatric disorders
Insomnia
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Psychiatric disorders
Personality change
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Renal and urinary disorders
Renal failure
|
11.8%
4/34 • Number of events 4
34 participants were evaluable for adverse events
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.8%
3/34 • Number of events 4
34 participants were evaluable for adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.8%
3/34 • Number of events 3
34 participants were evaluable for adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.9%
1/34 • Number of events 2
34 participants were evaluable for adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.9%
2/34 • Number of events 3
34 participants were evaluable for adverse events
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
5.9%
2/34 • Number of events 3
34 participants were evaluable for adverse events
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Vascular disorders
Hypertension
|
2.9%
1/34 • Number of events 3
34 participants were evaluable for adverse events
|
|
Vascular disorders
Hypotension
|
8.8%
3/34 • Number of events 3
34 participants were evaluable for adverse events
|
|
Vascular disorders
Thrombosis
|
5.9%
2/34 • Number of events 2
34 participants were evaluable for adverse events
|
Other adverse events
| Measure |
Pentostatin
n=34 participants at risk
pentostatin: 4 mg/m\^2 IV infusion over 20-30 min q 2 weeks
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
44.1%
15/34 • Number of events 67
34 participants were evaluable for adverse events
|
|
Cardiac disorders
Arrhythmia supraventricular
|
2.9%
1/34 • Number of events 2
34 participants were evaluable for adverse events
|
|
Cardiac disorders
Atrial fibrillation
|
2.9%
1/34 • Number of events 2
34 participants were evaluable for adverse events
|
|
Cardiac disorders
Cardiac disorder
|
8.8%
3/34 • Number of events 6
34 participants were evaluable for adverse events
|
|
Cardiac disorders
Edema
|
8.8%
3/34 • Number of events 13
34 participants were evaluable for adverse events
|
|
Cardiac disorders
Myocardial ischemia
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Cardiac disorders
Sinus tachycardia
|
11.8%
4/34 • Number of events 15
34 participants were evaluable for adverse events
|
|
Endocrine disorders
Cushingoid
|
2.9%
1/34 • Number of events 8
34 participants were evaluable for adverse events
|
|
Eye disorders
Cataract
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Eye disorders
Dry eye syndrome
|
14.7%
5/34 • Number of events 19
34 participants were evaluable for adverse events
|
|
Eye disorders
Extraocular muscle paresis
|
2.9%
1/34 • Number of events 2
34 participants were evaluable for adverse events
|
|
Eye disorders
Eye disorder
|
5.9%
2/34 • Number of events 4
34 participants were evaluable for adverse events
|
|
Eye disorders
Eye pain
|
2.9%
1/34 • Number of events 2
34 participants were evaluable for adverse events
|
|
Eye disorders
Glaucoma
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Eye disorders
Photophobia
|
8.8%
3/34 • Number of events 10
34 participants were evaluable for adverse events
|
|
Eye disorders
Vision blurred
|
11.8%
4/34 • Number of events 5
34 participants were evaluable for adverse events
|
|
Gastrointestinal disorders
Abdominal distension
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
1/34 • Number of events 2
34 participants were evaluable for adverse events
|
|
Gastrointestinal disorders
Constipation
|
17.6%
6/34 • Number of events 20
34 participants were evaluable for adverse events
|
|
Gastrointestinal disorders
Diarrhea
|
26.5%
9/34 • Number of events 13
34 participants were evaluable for adverse events
|
|
Gastrointestinal disorders
Dry mouth
|
14.7%
5/34 • Number of events 10
34 participants were evaluable for adverse events
|
|
Gastrointestinal disorders
Dyspepsia
|
2.9%
1/34 • Number of events 4
34 participants were evaluable for adverse events
|
|
Gastrointestinal disorders
Dysphagia
|
8.8%
3/34 • Number of events 5
34 participants were evaluable for adverse events
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
8.8%
3/34 • Number of events 7
34 participants were evaluable for adverse events
|
|
Gastrointestinal disorders
Esophageal stenosis
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Gastrointestinal disorders
Esophagitis
|
8.8%
3/34 • Number of events 6
34 participants were evaluable for adverse events
|
|
Gastrointestinal disorders
Mucositis oral
|
2.9%
1/34 • Number of events 3
34 participants were evaluable for adverse events
|
|
Gastrointestinal disorders
Nausea
|
32.4%
11/34 • Number of events 22
34 participants were evaluable for adverse events
|
|
Gastrointestinal disorders
Oral pain
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Gastrointestinal disorders
Vomiting
|
11.8%
4/34 • Number of events 9
34 participants were evaluable for adverse events
|
|
General disorders
Chest pain
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
General disorders
Chills
|
5.9%
2/34 • Number of events 2
34 participants were evaluable for adverse events
|
|
General disorders
Edema limbs
|
8.8%
3/34 • Number of events 6
34 participants were evaluable for adverse events
|
|
General disorders
Fatigue
|
35.3%
12/34 • Number of events 33
34 participants were evaluable for adverse events
|
|
General disorders
Fever
|
8.8%
3/34 • Number of events 4
34 participants were evaluable for adverse events
|
|
General disorders
Gait abnormal
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
General disorders
General symptom
|
5.9%
2/34 • Number of events 3
34 participants were evaluable for adverse events
|
|
General disorders
Ill-defined disorder
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
General disorders
Pain
|
20.6%
7/34 • Number of events 23
34 participants were evaluable for adverse events
|
|
Hepatobiliary disorders
Hepatic failure
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
5.9%
2/34 • Number of events 3
34 participants were evaluable for adverse events
|
|
Immune system disorders
Hypersensitivity
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Immune system disorders
Immune system disorder
|
2.9%
1/34 • Number of events 5
34 participants were evaluable for adverse events
|
|
Infections and infestations
Bladder infection
|
5.9%
2/34 • Number of events 2
34 participants were evaluable for adverse events
|
|
Infections and infestations
Infection
|
5.9%
2/34 • Number of events 2
34 participants were evaluable for adverse events
|
|
Infections and infestations
Infection without neutropenia
|
11.8%
4/34 • Number of events 6
34 participants were evaluable for adverse events
|
|
Infections and infestations
Opportunistic infection
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Infections and infestations
Otitis media
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Infections and infestations
Pneumonia
|
8.8%
3/34 • Number of events 3
34 participants were evaluable for adverse events
|
|
Infections and infestations
Skin infection
|
2.9%
1/34 • Number of events 3
34 participants were evaluable for adverse events
|
|
Infections and infestations
Tooth infection
|
2.9%
1/34 • Number of events 2
34 participants were evaluable for adverse events
|
|
Infections and infestations
Upper respiratory infection
|
8.8%
3/34 • Number of events 7
34 participants were evaluable for adverse events
|
|
Infections and infestations
Ureteritis
|
2.9%
1/34 • Number of events 2
34 participants were evaluable for adverse events
|
|
Infections and infestations
Urinary tract infection
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Infections and infestations
Wound infection
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Injury, poisoning and procedural complications
Bruising
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Investigations
Activated partial thromboplastin time prolonged
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Investigations
Alanine aminotransferase increased
|
58.8%
20/34 • Number of events 61
34 participants were evaluable for adverse events
|
|
Investigations
Alkaline phosphatase
|
20.6%
7/34 • Number of events 27
34 participants were evaluable for adverse events
|
|
Investigations
Alkaline phosphatase increased
|
20.6%
7/34 • Number of events 16
34 participants were evaluable for adverse events
|
|
Investigations
Aspartate aminotransferase increased
|
58.8%
20/34 • Number of events 72
34 participants were evaluable for adverse events
|
|
Investigations
Bilirubin associated with graft versus host disease (GVHD) for BMT studies
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Investigations
Blood bilirubin increased
|
17.6%
6/34 • Number of events 10
34 participants were evaluable for adverse events
|
|
Investigations
Creatinine increased
|
29.4%
10/34 • Number of events 23
34 participants were evaluable for adverse events
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.9%
1/34 • Number of events 4
34 participants were evaluable for adverse events
|
|
Investigations
INR increased
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Investigations
Laboratory test abnormal
|
17.6%
6/34 • Number of events 27
34 participants were evaluable for adverse events
|
|
Investigations
Leukocyte count decreased
|
32.4%
11/34 • Number of events 28
34 participants were evaluable for adverse events
|
|
Investigations
Lymphocyte count decreased
|
14.7%
5/34 • Number of events 27
34 participants were evaluable for adverse events
|
|
Investigations
Neutrophil count decreased
|
20.6%
7/34 • Number of events 15
34 participants were evaluable for adverse events
|
|
Investigations
Platelet count decreased
|
44.1%
15/34 • Number of events 46
34 participants were evaluable for adverse events
|
|
Investigations
Serum cholesterol increased
|
11.8%
4/34 • Number of events 4
34 participants were evaluable for adverse events
|
|
Investigations
Weight loss
|
8.8%
3/34 • Number of events 6
34 participants were evaluable for adverse events
|
|
Metabolism and nutrition disorders
Acidosis
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Metabolism and nutrition disorders
Alkalosis
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Metabolism and nutrition disorders
Anorexia
|
8.8%
3/34 • Number of events 6
34 participants were evaluable for adverse events
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
8.8%
3/34 • Number of events 5
34 participants were evaluable for adverse events
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
44.1%
15/34 • Number of events 71
34 participants were evaluable for adverse events
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
2/34 • Number of events 3
34 participants were evaluable for adverse events
|
|
Metabolism and nutrition disorders
Iron overload
|
2.9%
1/34 • Number of events 3
34 participants were evaluable for adverse events
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
17.6%
6/34 • Number of events 11
34 participants were evaluable for adverse events
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
29.4%
10/34 • Number of events 13
34 participants were evaluable for adverse events
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
5.9%
2/34 • Number of events 5
34 participants were evaluable for adverse events
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
11.8%
4/34 • Number of events 6
34 participants were evaluable for adverse events
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
11.8%
4/34 • Number of events 8
34 participants were evaluable for adverse events
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
5.9%
2/34 • Number of events 4
34 participants were evaluable for adverse events
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
8.8%
3/34 • Number of events 7
34 participants were evaluable for adverse events
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
14.7%
5/34 • Number of events 6
34 participants were evaluable for adverse events
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
14.7%
5/34 • Number of events 13
34 participants were evaluable for adverse events
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
32.4%
11/34 • Number of events 18
34 participants were evaluable for adverse events
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
2/34 • Number of events 5
34 participants were evaluable for adverse events
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
2/34 • Number of events 3
34 participants were evaluable for adverse events
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.9%
2/34 • Number of events 2
34 participants were evaluable for adverse events
|
|
Musculoskeletal and connective tissue disorders
Joint disorder
|
5.9%
2/34 • Number of events 5
34 participants were evaluable for adverse events
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
5.9%
2/34 • Number of events 4
34 participants were evaluable for adverse events
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
8.8%
3/34 • Number of events 6
34 participants were evaluable for adverse events
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
14.7%
5/34 • Number of events 5
34 participants were evaluable for adverse events
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
2/34 • Number of events 6
34 participants were evaluable for adverse events
|
|
Nervous system disorders
Ataxia
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Nervous system disorders
Cognitive disturbance
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Nervous system disorders
Depressed level of consciousness
|
2.9%
1/34 • Number of events 3
34 participants were evaluable for adverse events
|
|
Nervous system disorders
Dizziness
|
5.9%
2/34 • Number of events 2
34 participants were evaluable for adverse events
|
|
Nervous system disorders
Headache
|
5.9%
2/34 • Number of events 5
34 participants were evaluable for adverse events
|
|
Nervous system disorders
Neurological disorder NOS
|
5.9%
2/34 • Number of events 2
34 participants were evaluable for adverse events
|
|
Nervous system disorders
Peripheral motor neuropathy
|
8.8%
3/34 • Number of events 4
34 participants were evaluable for adverse events
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.8%
3/34 • Number of events 11
34 participants were evaluable for adverse events
|
|
Nervous system disorders
Tremor
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Psychiatric disorders
Anxiety
|
2.9%
1/34 • Number of events 12
34 participants were evaluable for adverse events
|
|
Psychiatric disorders
Confusion
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Psychiatric disorders
Depression
|
8.8%
3/34 • Number of events 7
34 participants were evaluable for adverse events
|
|
Psychiatric disorders
Insomnia
|
5.9%
2/34 • Number of events 3
34 participants were evaluable for adverse events
|
|
Renal and urinary disorders
Glomerular filtration rate decreased
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Renal and urinary disorders
Proteinuria
|
2.9%
1/34 • Number of events 2
34 participants were evaluable for adverse events
|
|
Renal and urinary disorders
Renal failure
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Renal and urinary disorders
Urogenital disorder
|
2.9%
1/34 • Number of events 4
34 participants were evaluable for adverse events
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
2.9%
1/34 • Number of events 3
34 participants were evaluable for adverse events
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Reproductive system and breast disorders
Reproductive tract disorder
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.8%
4/34 • Number of events 6
34 participants were evaluable for adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
26.5%
9/34 • Number of events 16
34 participants were evaluable for adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.9%
1/34 • Number of events 2
34 participants were evaluable for adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.8%
3/34 • Number of events 5
34 participants were evaluable for adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.9%
1/34 • Number of events 10
34 participants were evaluable for adverse events
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.8%
3/34 • Number of events 6
34 participants were evaluable for adverse events
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
2.9%
1/34 • Number of events 2
34 participants were evaluable for adverse events
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
5.9%
2/34 • Number of events 6
34 participants were evaluable for adverse events
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.9%
1/34 • Number of events 5
34 participants were evaluable for adverse events
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
32.4%
11/34 • Number of events 63
34 participants were evaluable for adverse events
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation associated with graft versus host disease (GVHD) for BMT studies
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
11.8%
4/34 • Number of events 20
34 participants were evaluable for adverse events
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
2.9%
1/34 • Number of events 2
34 participants were evaluable for adverse events
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
2.9%
1/34 • Number of events 2
34 participants were evaluable for adverse events
|
|
Skin and subcutaneous tissue disorders
Sweating
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Vascular disorders
Flushing
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Vascular disorders
Hypertension
|
11.8%
4/34 • Number of events 8
34 participants were evaluable for adverse events
|
|
Vascular disorders
Hypotension
|
2.9%
1/34 • Number of events 1
34 participants were evaluable for adverse events
|
|
Vascular disorders
Thrombosis
|
2.9%
1/34 • Number of events 3
34 participants were evaluable for adverse events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60