Trial Outcomes & Findings for Clofarabine Pre-conditioning Followed by Stem Cell Transplant for Non-remission AML (NCT NCT04002115)
NCT ID: NCT04002115
Last Updated: 2023-09-14
Results Overview
The CR rate at 30 days (Day +30) post stem cell transplant infusion
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
30 days
Results posted on
2023-09-14
Participant Flow
Both subjects were between age 56 and 75 years old, therefore they were assigned treatment of Regimen B.
Participant milestones
| Measure |
Clofarabine 30 mg/m^2
Day -14 through Day -10 Clofarabine 30 mg/m\^2, Day - 9 Day of rest, Day - 8 Day of rest, Day - 7 Day of rest, Day - 6 Fludarabine 24 mg/m\^2 IV and Cyclophosphamide 14.5 mg/kg IV for Regimen B, Day - 5 Fludarabine 24 mg/m\^2 IV and Cyclophosphamide 14.5 mg/kg IV, Day - 4 Fludarabine 24 mg/m\^2 IV, Day - 3 Fludarabine 24 mg/m\^2 IV, Day - 2 Fludarabine 24 mg/m\^2 IV, Day -1 Total Body Irradiation 200 cGys, Day 0 stem cell transplant infusion, Day +1 Day of rest, Day +2 Day of rest, Day +3 Cyclophosphamide 50 mg/kg IV, Day +4 Cyclophosphamide 50 mg/kg IV, Day +5 Start G-CSF, Tacrolimus, and MMF.
Clofarabine: Clofarabine to be administered pre-stem cell transplant infusion ("Day 0") once a day for 5 days total.
Fludarabine: Fludarabine will be administered once a day for 5 days as part of the transplant conditioning regimen.
Total Body Irradiation (TBI): TBI will be administered at a dose of 200cGys on Day -1 prior to transplant
Cyclophosphamide: Cyclophosphamide will be given once a day for 2 days after the transplant infusion.
Granulocyte Colony-Stimulating Factor: G-CSF will be administered to subjects starting on Day +5 and will continue as clinically indicated
Tacrolimus: Tacrolimus will be administered to subjects starting on Day +5 and will continue as clinically indicated
Cellcept: Mycophenolate Mofetil will be administered to subjects starting on Day +5 and will continue as clinically indicated
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clofarabine Pre-conditioning Followed by Stem Cell Transplant for Non-remission AML
Baseline characteristics by cohort
| Measure |
Clofarabine 30 mg/m^2
n=2 Participants
Day -14 through Day -10 Clofarabine 30 mg/m\^2, Day - 9 Day of rest, Day - 8 Day of rest, Day - 7 Day of rest, Day - 6, Fludarabine 24 mg/m\^2 IV and Cyclophosphamide 14.5 mg/kg IV for Regimen B, Day - 5 Fludarabine 24 mg/m\^2 IV and Cyclophosphamide 14.5 mg/kg IV for Regimen B, Day - 4 Fludarabine 24 mg/m\^2 IV for Regimen B, Day - 3 Fludarabine 24 mg/m\^2 IV for Regimen B, Day - 2 Fludarabine 24 mg/m\^2 IV for Regimen B, Day -1 Total Body Irradiation 200 cGys, Day 0 stem cell transplant infusion, Day +1 Day of rest, Day +2 Day of rest, Day +3 Cyclophosphamide 50 mg/kg IV, Day +4 Cyclophosphamide 50 mg/kg IV, Day +5 Start G-CSF, Tacrolimus, and MMF.
|
|---|---|
|
Age, Continuous
|
68 years
STANDARD_DEVIATION 0 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: The CR rate at 30 days (Day +30) post stem cell transplant infusion was 2/2.
The CR rate at 30 days (Day +30) post stem cell transplant infusion
Outcome measures
| Measure |
Clofarabine 30 mg/m^2
n=2 Participants
Day -14 through Day -10 Clofarabine 30 mg/m\^2, Day - 9 Day of rest, Day - 8 Day of rest, Day - 7 Day of rest, Day - 6 Fludarabine 24 mg/m\^2 IV and Cyclophosphamide 14.5 mg/kg IV for Regimen B, Day - 5 Fludarabine 24 mg/m\^2 IV and Cyclophosphamide 14.5 mg/kg IV for Regimen B, Day - 4 Fludarabine 24 mg/m\^2 IV for Regimen B, Day - 3 Fludarabine 24 mg/m\^2 IV for Regimen B, Day - 2 Fludarabine 24 mg/m\^2 IV for Regimen B, Day -1 Total Body Irradiation 200 cGys, Day 0 stem cell transplant infusion, Day +1 Day of rest, Day +2 Day of rest, Day +3 Cyclophosphamide 50 mg/kg IV, Day +4 Cyclophosphamide 50 mg/kg IV, Day +5 Start G-CSF, Tacrolimus, and MMF.
|
|---|---|
|
Complete Remission (CR) Rate at Day 30 Post HSCT
|
100 percentage of Participants
|
SECONDARY outcome
Timeframe: 100 daysPopulation: The rate of non-relapse related mortality at 100 days post transplant (Day +100) is 0/2.
Determine the rate of non-relapse related mortality at 100 days post transplant (Day +100)
Outcome measures
| Measure |
Clofarabine 30 mg/m^2
n=2 Participants
Day -14 through Day -10 Clofarabine 30 mg/m\^2, Day - 9 Day of rest, Day - 8 Day of rest, Day - 7 Day of rest, Day - 6 Fludarabine 24 mg/m\^2 IV and Cyclophosphamide 14.5 mg/kg IV for Regimen B, Day - 5 Fludarabine 24 mg/m\^2 IV and Cyclophosphamide 14.5 mg/kg IV for Regimen B, Day - 4 Fludarabine 24 mg/m\^2 IV for Regimen B, Day - 3 Fludarabine 24 mg/m\^2 IV for Regimen B, Day - 2 Fludarabine 24 mg/m\^2 IV for Regimen B, Day -1 Total Body Irradiation 200 cGys, Day 0 stem cell transplant infusion, Day +1 Day of rest, Day +2 Day of rest, Day +3 Cyclophosphamide 50 mg/kg IV, Day +4 Cyclophosphamide 50 mg/kg IV, Day +5 Start G-CSF, Tacrolimus, and MMF.
|
|---|---|
|
Non-relapse Related Mortality
|
0 percentage of Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Rate of engraftment was 0/2.
Rates of engraftment, defined as the first day of Absolute Neutrophil Count (ANC) greater than 500 for the first of three consecutive days
Outcome measures
| Measure |
Clofarabine 30 mg/m^2
n=2 Participants
Day -14 through Day -10 Clofarabine 30 mg/m\^2, Day - 9 Day of rest, Day - 8 Day of rest, Day - 7 Day of rest, Day - 6 Fludarabine 24 mg/m\^2 IV and Cyclophosphamide 14.5 mg/kg IV for Regimen B, Day - 5 Fludarabine 24 mg/m\^2 IV and Cyclophosphamide 14.5 mg/kg IV for Regimen B, Day - 4 Fludarabine 24 mg/m\^2 IV for Regimen B, Day - 3 Fludarabine 24 mg/m\^2 IV for Regimen B, Day - 2 Fludarabine 24 mg/m\^2 IV for Regimen B, Day -1 Total Body Irradiation 200 cGys, Day 0 stem cell transplant infusion, Day +1 Day of rest, Day +2 Day of rest, Day +3 Cyclophosphamide 50 mg/kg IV, Day +4 Cyclophosphamide 50 mg/kg IV, Day +5 Start G-CSF, Tacrolimus, and MMF.
|
|---|---|
|
Neutrophil Engraftment
|
0 percentage of Participants
|
SECONDARY outcome
Timeframe: 100 daysPopulation: The rate of any grade (1-4) of acute GvHD as measured from day of transplantation to Day +100 was 0/2.
The rate of any grade (1-4) of acute GvHD as measured from day of transplantation to Day +100 using the Glucksberg criteria.
Outcome measures
| Measure |
Clofarabine 30 mg/m^2
n=2 Participants
Day -14 through Day -10 Clofarabine 30 mg/m\^2, Day - 9 Day of rest, Day - 8 Day of rest, Day - 7 Day of rest, Day - 6 Fludarabine 24 mg/m\^2 IV and Cyclophosphamide 14.5 mg/kg IV for Regimen B, Day - 5 Fludarabine 24 mg/m\^2 IV and Cyclophosphamide 14.5 mg/kg IV for Regimen B, Day - 4 Fludarabine 24 mg/m\^2 IV for Regimen B, Day - 3 Fludarabine 24 mg/m\^2 IV for Regimen B, Day - 2 Fludarabine 24 mg/m\^2 IV for Regimen B, Day -1 Total Body Irradiation 200 cGys, Day 0 stem cell transplant infusion, Day +1 Day of rest, Day +2 Day of rest, Day +3 Cyclophosphamide 50 mg/kg IV, Day +4 Cyclophosphamide 50 mg/kg IV, Day +5 Start G-CSF, Tacrolimus, and MMF.
|
|---|---|
|
Rate of Acute Graft-versus-host Disease (GVHD)
|
0 percentage of Participants
|
SECONDARY outcome
Timeframe: 100 daysPopulation: The highest grade (1-4) of acute GvHD experienced by participants as measured from day of transplantation to Day +100 was 0/2.
The highest grade (1-4) of acute GvHD experienced by participants as measured from day of transplantation to Day +100 using the Glucksberg criteria
Outcome measures
| Measure |
Clofarabine 30 mg/m^2
n=2 Participants
Day -14 through Day -10 Clofarabine 30 mg/m\^2, Day - 9 Day of rest, Day - 8 Day of rest, Day - 7 Day of rest, Day - 6 Fludarabine 24 mg/m\^2 IV and Cyclophosphamide 14.5 mg/kg IV for Regimen B, Day - 5 Fludarabine 24 mg/m\^2 IV and Cyclophosphamide 14.5 mg/kg IV for Regimen B, Day - 4 Fludarabine 24 mg/m\^2 IV for Regimen B, Day - 3 Fludarabine 24 mg/m\^2 IV for Regimen B, Day - 2 Fludarabine 24 mg/m\^2 IV for Regimen B, Day -1 Total Body Irradiation 200 cGys, Day 0 stem cell transplant infusion, Day +1 Day of rest, Day +2 Day of rest, Day +3 Cyclophosphamide 50 mg/kg IV, Day +4 Cyclophosphamide 50 mg/kg IV, Day +5 Start G-CSF, Tacrolimus, and MMF.
|
|---|---|
|
Severity of Acute Graft-versus-host Disease (GVHD)
|
0 percentage of Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: The incidence of any grade (1-4) of Chronic GvHD as measured from Day +100 to Year 1 post-transplantation was 0/2.
The rate of any grade (1-4) of Chronic GvHD as measured from Day +100 to Year 1 post-transplantation using the Glucksberg criteria.
Outcome measures
| Measure |
Clofarabine 30 mg/m^2
n=2 Participants
Day -14 through Day -10 Clofarabine 30 mg/m\^2, Day - 9 Day of rest, Day - 8 Day of rest, Day - 7 Day of rest, Day - 6 Fludarabine 24 mg/m\^2 IV and Cyclophosphamide 14.5 mg/kg IV for Regimen B, Day - 5 Fludarabine 24 mg/m\^2 IV and Cyclophosphamide 14.5 mg/kg IV for Regimen B, Day - 4 Fludarabine 24 mg/m\^2 IV for Regimen B, Day - 3 Fludarabine 24 mg/m\^2 IV for Regimen B, Day - 2 Fludarabine 24 mg/m\^2 IV for Regimen B, Day -1 Total Body Irradiation 200 cGys, Day 0 stem cell transplant infusion, Day +1 Day of rest, Day +2 Day of rest, Day +3 Cyclophosphamide 50 mg/kg IV, Day +4 Cyclophosphamide 50 mg/kg IV, Day +5 Start G-CSF, Tacrolimus, and MMF.
|
|---|---|
|
Rate of Chronic GVHD
|
0 percentage of Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: The highest overall grade (1-4) of chronic GvHD experienced by participants as measured from Day +100 to Year 1 post-transplantation was 0/2.
The highest overall grade (1-4) of chronic GvHD experienced by participants as measured from Day +100 to Year 1 post-transplantation using the Glucksberg criteria
Outcome measures
| Measure |
Clofarabine 30 mg/m^2
n=2 Participants
Day -14 through Day -10 Clofarabine 30 mg/m\^2, Day - 9 Day of rest, Day - 8 Day of rest, Day - 7 Day of rest, Day - 6 Fludarabine 24 mg/m\^2 IV and Cyclophosphamide 14.5 mg/kg IV for Regimen B, Day - 5 Fludarabine 24 mg/m\^2 IV and Cyclophosphamide 14.5 mg/kg IV for Regimen B, Day - 4 Fludarabine 24 mg/m\^2 IV for Regimen B, Day - 3 Fludarabine 24 mg/m\^2 IV for Regimen B, Day - 2 Fludarabine 24 mg/m\^2 IV for Regimen B, Day -1 Total Body Irradiation 200 cGys, Day 0 stem cell transplant infusion, Day +1 Day of rest, Day +2 Day of rest, Day +3 Cyclophosphamide 50 mg/kg IV, Day +4 Cyclophosphamide 50 mg/kg IV, Day +5 Start G-CSF, Tacrolimus, and MMF.
|
|---|---|
|
Severity of Chronic GVHD
|
0 percentage of Participants
|
Adverse Events
Clofarabine 30 mg/m^2
Serious events: 1 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Clofarabine 30 mg/m^2
n=2 participants at risk
Day -14 through Day -10 Clofarabine 30 mg/m\^2, Day - 9 Day of rest, Day - 8 Day of rest, Day - 7 Day of rest, Day - 6 Fludarabine 24 mg/m\^2 IV and Cyclophosphamide 14.5 mg/kg IV for Regimen B, Day - 5, Fludarabine 24 mg/m\^2 IV and Cyclophosphamide 14.5 mg/kg IV for Regimen B, Day - 4 Fludarabine 24 mg/m\^2 IV for Regimen B, Day - 3 Fludarabine 24 mg/m\^2 IV for Regimen B, Day - 2 Fludarabine 24 mg/m\^2 IV for Regimen, Day -1 Total Body Irradiation 200 cGys, Day 0 stem cell transplant infusion, Day +1 Day of rest, Day +2 Day of rest, Day +3 Cyclophosphamide 50 mg/kg IV, Day +4 Cyclophosphamide 50 mg/kg IV, Day +5 Start G-CSF, Tacrolimus, and MMF.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
pulmonary edema
|
50.0%
1/2 • Number of events 1 • 1st subject: 10 months 2nd subject: 5 months
|
|
General disorders
Multiorgan failure
|
50.0%
1/2 • Number of events 1 • 1st subject: 10 months 2nd subject: 5 months
|
|
Renal and urinary disorders
Acute kidney injury
|
50.0%
1/2 • Number of events 1 • 1st subject: 10 months 2nd subject: 5 months
|
Other adverse events
| Measure |
Clofarabine 30 mg/m^2
n=2 participants at risk
Day -14 through Day -10 Clofarabine 30 mg/m\^2, Day - 9 Day of rest, Day - 8 Day of rest, Day - 7 Day of rest, Day - 6 Fludarabine 24 mg/m\^2 IV and Cyclophosphamide 14.5 mg/kg IV for Regimen B, Day - 5, Fludarabine 24 mg/m\^2 IV and Cyclophosphamide 14.5 mg/kg IV for Regimen B, Day - 4 Fludarabine 24 mg/m\^2 IV for Regimen B, Day - 3 Fludarabine 24 mg/m\^2 IV for Regimen B, Day - 2 Fludarabine 24 mg/m\^2 IV for Regimen, Day -1 Total Body Irradiation 200 cGys, Day 0 stem cell transplant infusion, Day +1 Day of rest, Day +2 Day of rest, Day +3 Cyclophosphamide 50 mg/kg IV, Day +4 Cyclophosphamide 50 mg/kg IV, Day +5 Start G-CSF, Tacrolimus, and MMF.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
1/2 • Number of events 6 • 1st subject: 10 months 2nd subject: 5 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
50.0%
1/2 • Number of events 1 • 1st subject: 10 months 2nd subject: 5 months
|
|
Infections and infestations
Infections and infestations
|
50.0%
1/2 • Number of events 1 • 1st subject: 10 months 2nd subject: 5 months
|
|
Infections and infestations
Pharyngitis
|
50.0%
1/2 • Number of events 1 • 1st subject: 10 months 2nd subject: 5 months
|
|
Infections and infestations
Sepsis
|
50.0%
1/2 • Number of events 1 • 1st subject: 10 months 2nd subject: 5 months
|
|
Investigations
Alanine aminotransferase increased
|
100.0%
2/2 • Number of events 5 • 1st subject: 10 months 2nd subject: 5 months
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
2/2 • Number of events 3 • 1st subject: 10 months 2nd subject: 5 months
|
|
Investigations
Blood bilirubin increased
|
100.0%
2/2 • Number of events 3 • 1st subject: 10 months 2nd subject: 5 months
|
|
Investigations
Creatinine increased
|
50.0%
1/2 • Number of events 1 • 1st subject: 10 months 2nd subject: 5 months
|
|
Investigations
Platelet count decreased
|
50.0%
1/2 • Number of events 1 • 1st subject: 10 months 2nd subject: 5 months
|
|
Investigations
White blood cell decreased
|
50.0%
1/2 • Number of events 2 • 1st subject: 10 months 2nd subject: 5 months
|
|
Metabolism and nutrition disorders
Anorexia
|
100.0%
2/2 • Number of events 2 • 1st subject: 10 months 2nd subject: 5 months
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
50.0%
1/2 • Number of events 3 • 1st subject: 10 months 2nd subject: 5 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
100.0%
2/2 • Number of events 2 • 1st subject: 10 months 2nd subject: 5 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
50.0%
1/2 • Number of events 2 • 1st subject: 10 months 2nd subject: 5 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
100.0%
2/2 • Number of events 5 • 1st subject: 10 months 2nd subject: 5 months
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
50.0%
1/2 • Number of events 2 • 1st subject: 10 months 2nd subject: 5 months
|
|
Cardiac disorders
Sinus tachycardia
|
50.0%
1/2 • Number of events 1 • 1st subject: 10 months 2nd subject: 5 months
|
|
Gastrointestinal disorders
Mucositis oral
|
50.0%
1/2 • Number of events 4 • 1st subject: 10 months 2nd subject: 5 months
|
|
Gastrointestinal disorders
Nausea
|
100.0%
2/2 • Number of events 4 • 1st subject: 10 months 2nd subject: 5 months
|
|
General disorders
Edema limbs
|
50.0%
1/2 • Number of events 9 • 1st subject: 10 months 2nd subject: 5 months
|
|
General disorders
Fatigue
|
50.0%
1/2 • Number of events 2 • 1st subject: 10 months 2nd subject: 5 months
|
|
General disorders
Fever
|
50.0%
1/2 • Number of events 1 • 1st subject: 10 months 2nd subject: 5 months
|
|
General disorders
Non-cardiac chest pain
|
50.0%
1/2 • Number of events 1 • 1st subject: 10 months 2nd subject: 5 months
|
|
General disorders
Pain
|
50.0%
1/2 • Number of events 1 • 1st subject: 10 months 2nd subject: 5 months
|
|
Nervous system disorders
Headche
|
50.0%
1/2 • Number of events 5 • 1st subject: 10 months 2nd subject: 5 months
|
|
Nervous system disorders
Lethargy
|
50.0%
1/2 • Number of events 3 • 1st subject: 10 months 2nd subject: 5 months
|
|
Renal and urinary disorders
Cystitis noninfective
|
50.0%
1/2 • Number of events 1 • 1st subject: 10 months 2nd subject: 5 months
|
|
Reproductive system and breast disorders
Genital edema
|
50.0%
1/2 • Number of events 2 • 1st subject: 10 months 2nd subject: 5 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
50.0%
1/2 • Number of events 1 • 1st subject: 10 months 2nd subject: 5 months
|
|
Cardiac disorders
Heart failure
|
50.0%
1/2 • Number of events 1 • 1st subject: 10 months 2nd subject: 5 months
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
100.0%
2/2 • Number of events 2 • 1st subject: 10 months 2nd subject: 5 months
|
|
Investigations
Weight gain
|
100.0%
2/2 • Number of events 17 • 1st subject: 10 months 2nd subject: 5 months
|
|
Investigations
Alkaline phosphatase increased
|
50.0%
1/2 • Number of events 1 • 1st subject: 10 months 2nd subject: 5 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
1/2 • Number of events 3 • 1st subject: 10 months 2nd subject: 5 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
50.0%
1/2 • Number of events 3 • 1st subject: 10 months 2nd subject: 5 months
|
|
Musculoskeletal and connective tissue disorders
Hypophosphatemia
|
50.0%
1/2 • Number of events 1 • 1st subject: 10 months 2nd subject: 5 months
|
|
Nervous system disorders
Dizziness
|
50.0%
1/2 • Number of events 2 • 1st subject: 10 months 2nd subject: 5 months
|
|
Nervous system disorders
Encephalopathy
|
50.0%
1/2 • Number of events 1 • 1st subject: 10 months 2nd subject: 5 months
|
|
Nervous system disorders
Syncope
|
50.0%
1/2 • Number of events 2 • 1st subject: 10 months 2nd subject: 5 months
|
|
Nervous system disorders
Tremor
|
50.0%
1/2 • Number of events 1 • 1st subject: 10 months 2nd subject: 5 months
|
|
Eye disorders
Blurred vision
|
50.0%
1/2 • Number of events 1 • 1st subject: 10 months 2nd subject: 5 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
50.0%
1/2 • Number of events 1 • 1st subject: 10 months 2nd subject: 5 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
50.0%
1/2 • Number of events 1 • 1st subject: 10 months 2nd subject: 5 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
50.0%
1/2 • Number of events 1 • 1st subject: 10 months 2nd subject: 5 months
|
|
Psychiatric disorders
Anxiety
|
50.0%
1/2 • Number of events 1 • 1st subject: 10 months 2nd subject: 5 months
|
|
Renal and urinary disorders
Urinary frequency
|
50.0%
1/2 • Number of events 1 • 1st subject: 10 months 2nd subject: 5 months
|
|
Renal and urinary disorders
Urinary urgency
|
50.0%
1/2 • Number of events 1 • 1st subject: 10 months 2nd subject: 5 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
50.0%
1/2 • Number of events 2 • 1st subject: 10 months 2nd subject: 5 months
|
|
Vascular disorders
Hypertension
|
50.0%
1/2 • Number of events 5 • 1st subject: 10 months 2nd subject: 5 months
|
|
Vascular disorders
Hypotension
|
50.0%
1/2 • Number of events 1 • 1st subject: 10 months 2nd subject: 5 months
|
|
Renal and urinary disorders
Renal and urinary disorders
|
50.0%
1/2 • Number of events 1 • 1st subject: 10 months 2nd subject: 5 months
|
|
Investigations
Increased bicarbonate level
|
50.0%
1/2 • Number of events 2 • 1st subject: 10 months 2nd subject: 5 months
|
|
Investigations
Abnormal EKG
|
50.0%
1/2 • Number of events 1 • 1st subject: 10 months 2nd subject: 5 months
|
|
Investigations
Increased BUN
|
50.0%
1/2 • Number of events 5 • 1st subject: 10 months 2nd subject: 5 months
|
|
Investigations
Increased RDW
|
50.0%
1/2 • Number of events 1 • 1st subject: 10 months 2nd subject: 5 months
|
|
Investigations
Increased specific gravity
|
50.0%
1/2 • Number of events 1 • 1st subject: 10 months 2nd subject: 5 months
|
|
Investigations
Hypoproteinemia
|
50.0%
1/2 • Number of events 1 • 1st subject: 10 months 2nd subject: 5 months
|
|
Investigations
Bladder wall thickening on CT abdomen
|
50.0%
1/2 • Number of events 1 • 1st subject: 10 months 2nd subject: 5 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place