Trial Outcomes & Findings for Fludarabine Phosphate, Cyclophosphamide, Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Blood Cancer (NCT NCT03333486)
NCT ID: NCT03333486
Last Updated: 2025-07-04
Results Overview
The number of participants that relapse within 1 year.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
At 1 year
Results posted on
2025-07-04
Participant Flow
Participant milestones
| Measure |
Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT)
Patients receive fludarabine phosphate IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 2 hours on days -6 and -5. Patients undergo TBI on days -1 and PBSCT on day 0.
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Peripheral Blood Stem Cell Transplantation: Undergo PBSCT
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT)
Patients receive fludarabine phosphate IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 2 hours on days -6 and -5. Patients undergo TBI on days -1 and PBSCT on day 0.
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Peripheral Blood Stem Cell Transplantation: Undergo PBSCT
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Fludarabine Phosphate, Cyclophosphamide, Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Blood Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT)
n=31 Participants
Patients receive fludarabine phosphate IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 2 hours on days -6 and -5. Patients undergo TBI on days -1 and PBSCT on day 0.
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Peripheral Blood Stem Cell Transplantation: Undergo PBSCT
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 1 yearPopulation: All treated and eligible patients
The number of participants that relapse within 1 year.
Outcome measures
| Measure |
Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT)
n=31 Participants
Patients receive fludarabine phosphate IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 2 hours on days -6 and -5. Patients undergo TBI on days -1 and PBSCT on day 0.
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Peripheral Blood Stem Cell Transplantation: Undergo PBSCT
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Relapse Rate
|
14 Participants
|
SECONDARY outcome
Timeframe: At 1 year post-transplantPopulation: All treated and eligible patients
Absolute Neutrophil Count Engraftment rate was defined as the number of participants that received an engraftment within 1 year post-transplant and ANC \> 0.5x10\^9/L for three consecutive days, out of the total number of participants. The rate was computed with corresponding exact 95% confidence intervals based on the methodology of Clopper and Pearson.
Outcome measures
| Measure |
Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT)
n=31 Participants
Patients receive fludarabine phosphate IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 2 hours on days -6 and -5. Patients undergo TBI on days -1 and PBSCT on day 0.
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Peripheral Blood Stem Cell Transplantation: Undergo PBSCT
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
ANC Engraftment Rate, the Percentage of Participants That Had a Successful Engraftment
|
84 percentage of participants
Interval 66.0 to 95.0
|
SECONDARY outcome
Timeframe: At 1 year post-transplantPopulation: All treated and eligible patients
Platelet Engraftment rate was defined as the number of participants that received an engraftment within 1 year post-transplant and the platelets \>= 20 x 10\^9/L after 7 consecutive days with no platelet transfusions, out of the total number of participants. The rate was computed with corresponding exact 95% confidence intervals based on the methodology of Clopper and Pearson.
Outcome measures
| Measure |
Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT)
n=31 Participants
Patients receive fludarabine phosphate IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 2 hours on days -6 and -5. Patients undergo TBI on days -1 and PBSCT on day 0.
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Peripheral Blood Stem Cell Transplantation: Undergo PBSCT
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Platelet Engraftment Rate, the Percentage of Participants That Had a Successful Engraftment
|
77 percentage of participants
Interval 59.0 to 90.0
|
SECONDARY outcome
Timeframe: At 100 days post-transplantPopulation: All treated and eligible patients
Will be computed with corresponding exact 95% confidence intervals based on the methodology of Clopper and Pearson.
Outcome measures
| Measure |
Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT)
n=31 Participants
Patients receive fludarabine phosphate IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 2 hours on days -6 and -5. Patients undergo TBI on days -1 and PBSCT on day 0.
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Peripheral Blood Stem Cell Transplantation: Undergo PBSCT
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Proportion of Participants With Acute Graft Versus Host Disease (GVHD)
|
0.3226 proportion of participants
Interval 0.1668 to 0.5137
|
SECONDARY outcome
Timeframe: At 1 year post-transplantPopulation: All treated and eligible patients
Will be computed with corresponding exact 95% confidence intervals based on the methodology of Clopper and Pearson.
Outcome measures
| Measure |
Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT)
n=31 Participants
Patients receive fludarabine phosphate IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 2 hours on days -6 and -5. Patients undergo TBI on days -1 and PBSCT on day 0.
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Peripheral Blood Stem Cell Transplantation: Undergo PBSCT
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Proportion of Participants With Chronic Graft Versus Host Disease (GVHD)
|
0.1935 proportion of participants
Interval 0.0745 to 0.3747
|
SECONDARY outcome
Timeframe: up to 5 years and 8 monthsPopulation: All treated and eligible patients
Will be computed with corresponding exact 95% confidence intervals based on the methodology of Clopper and Pearson. Will be obtained using the product-limit based Kaplan-Meier method.
Outcome measures
| Measure |
Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT)
n=31 Participants
Patients receive fludarabine phosphate IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 2 hours on days -6 and -5. Patients undergo TBI on days -1 and PBSCT on day 0.
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Peripheral Blood Stem Cell Transplantation: Undergo PBSCT
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Overall Survival
|
15.7 months
Interval 7.1 to
Upper limit not reached
|
SECONDARY outcome
Timeframe: up to 5 years and 8 monthsPopulation: All treated and eligible patients
Will be computed with corresponding exact 95% confidence intervals based on the methodology of Clopper and Pearson. Will be obtained using the product-limit based Kaplan-Meier method.
Outcome measures
| Measure |
Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT)
n=31 Participants
Patients receive fludarabine phosphate IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 2 hours on days -6 and -5. Patients undergo TBI on days -1 and PBSCT on day 0.
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Peripheral Blood Stem Cell Transplantation: Undergo PBSCT
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Progression Free Survival
|
15.7 months
Interval 5.5 to 49.5
|
SECONDARY outcome
Timeframe: At 1 year post-transplantPopulation: All treated and eligible patients
Will be computed with corresponding exact 95% confidence intervals based on the methodology of Clopper and Pearson.
Outcome measures
| Measure |
Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT)
n=31 Participants
Patients receive fludarabine phosphate IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 2 hours on days -6 and -5. Patients undergo TBI on days -1 and PBSCT on day 0.
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Peripheral Blood Stem Cell Transplantation: Undergo PBSCT
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Transplant Related Mortality
|
0.0323 proportion of participants
Interval 0.0008 to 0.167
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 1 yearWill be assessed by bone marrow transplantation SOC immunophenotyping panel and by analysis of cytomegalovirus-specific immunity.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At 30 daysPopulation: All treated and eligible patients. Samples were not obtained at day 100 for 8 subjects.
Mean lymphoid chimerism expressed as a percentage of donor cells
Outcome measures
| Measure |
Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT)
n=23 Participants
Patients receive fludarabine phosphate IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 2 hours on days -6 and -5. Patients undergo TBI on days -1 and PBSCT on day 0.
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Peripheral Blood Stem Cell Transplantation: Undergo PBSCT
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Lymphoid Chimerism Expressed as a Percentage of Donor Cells
|
99.85 percentage of donor cells
Standard Deviation 0.46
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At 100 daysPopulation: All treated and eligible patients. Samples were not obtained at day 100 for 8 subjects.
Mean myeloid chimerism expressed as a percentage of donor cells
Outcome measures
| Measure |
Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT)
n=23 Participants
Patients receive fludarabine phosphate IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 2 hours on days -6 and -5. Patients undergo TBI on days -1 and PBSCT on day 0.
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Peripheral Blood Stem Cell Transplantation: Undergo PBSCT
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Myeloid Chimerism Expressed as a Percentage of Donor Cells
|
99.93 percentage of donor cells
Standard Deviation 0.22
|
Adverse Events
Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT)
Serious events: 8 serious events
Other events: 27 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT)
n=31 participants at risk
Patients receive fludarabine phosphate IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 2 hours on days -6 and -5. Patients undergo TBI on days -1 and PBSCT on day 0.
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Peripheral Blood Stem Cell Transplantation: Undergo PBSCT
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Hepatobiliary disorders
Hepatic failure
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Immune system disorders
Immune system disorders - Other, specify
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Infections and infestations
Infections and infestations - Other, specify
|
6.5%
2/31 • Number of events 2 • 5 years and 8.5 months
|
|
Infections and infestations
Sepsis
|
6.5%
2/31 • Number of events 3 • 5 years and 8.5 months
|
|
Infections and infestations
Lung infection
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Investigations
Investigations - Other, specify
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Investigations
Platelet count decreased
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
Other adverse events
| Measure |
Treatment (Fludarabine, Cyclophosphamide, TBI, PBSCT)
n=31 participants at risk
Patients receive fludarabine phosphate IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 2 hours on days -6 and -5. Patients undergo TBI on days -1 and PBSCT on day 0.
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Peripheral Blood Stem Cell Transplantation: Undergo PBSCT
Total-Body Irradiation: Undergo TBI
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
45.2%
14/31 • Number of events 15 • 5 years and 8.5 months
|
|
Cardiac disorders
Atrial fibrillation
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Gastrointestinal disorders
Abdominal pain
|
12.9%
4/31 • Number of events 4 • 5 years and 8.5 months
|
|
Gastrointestinal disorders
Ascites
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Gastrointestinal disorders
Colitis
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Gastrointestinal disorders
Diarrhea
|
54.8%
17/31 • Number of events 22 • 5 years and 8.5 months
|
|
Gastrointestinal disorders
Dry mouth
|
6.5%
2/31 • Number of events 2 • 5 years and 8.5 months
|
|
Gastrointestinal disorders
Fecal incontinence
|
9.7%
3/31 • Number of events 3 • 5 years and 8.5 months
|
|
Gastrointestinal disorders
Flatulence
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
16.1%
5/31 • Number of events 5 • 5 years and 8.5 months
|
|
Gastrointestinal disorders
Ileus
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Gastrointestinal disorders
Mucositis oral
|
12.9%
4/31 • Number of events 4 • 5 years and 8.5 months
|
|
Gastrointestinal disorders
Nausea
|
58.1%
18/31 • Number of events 20 • 5 years and 8.5 months
|
|
Gastrointestinal disorders
Oral pain
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Gastrointestinal disorders
Vomiting
|
32.3%
10/31 • Number of events 11 • 5 years and 8.5 months
|
|
Gastrointestinal disorders
Oral dysesthesia
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
General disorders
Chills
|
9.7%
3/31 • Number of events 3 • 5 years and 8.5 months
|
|
General disorders
Edema face
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
General disorders
Fatigue
|
35.5%
11/31 • Number of events 12 • 5 years and 8.5 months
|
|
General disorders
Fever
|
16.1%
5/31 • Number of events 5 • 5 years and 8.5 months
|
|
General disorders
Flu like symptoms
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
General disorders
Malaise
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
General disorders
Pain
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
General disorders
Edema limbs
|
32.3%
10/31 • Number of events 12 • 5 years and 8.5 months
|
|
General disorders
Localized edema
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
General disorders
Non-cardiac chest pain
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Immune system disorders
Allergic reaction
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Immune system disorders
Cytokine release syndrome
|
22.6%
7/31 • Number of events 8 • 5 years and 8.5 months
|
|
Infections and infestations
Infections and infestations - Other, specify
|
22.6%
7/31 • Number of events 10 • 5 years and 8.5 months
|
|
Infections and infestations
Otitis media
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Infections and infestations
Sepsis
|
6.5%
2/31 • Number of events 2 • 5 years and 8.5 months
|
|
Infections and infestations
Skin infection
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Infections and infestations
Lung infection
|
19.4%
6/31 • Number of events 6 • 5 years and 8.5 months
|
|
Investigations
Alanine aminotransferase increased
|
9.7%
3/31 • Number of events 3 • 5 years and 8.5 months
|
|
Investigations
Alkaline phosphatase increased
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Investigations
Aspartate aminotransferase increased
|
9.7%
3/31 • Number of events 3 • 5 years and 8.5 months
|
|
Investigations
Blood bilirubin increased
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Investigations
Creatinine increased
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Investigations
Platelet count decreased
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Metabolism and nutrition disorders
Anorexia
|
25.8%
8/31 • Number of events 10 • 5 years and 8.5 months
|
|
Metabolism and nutrition disorders
Dehydration
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.5%
2/31 • Number of events 3 • 5 years and 8.5 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
6.5%
2/31 • Number of events 2 • 5 years and 8.5 months
|
|
Nervous system disorders
Dizziness
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Nervous system disorders
Dysgeusia
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Nervous system disorders
Encephalopathy
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Nervous system disorders
Headache
|
9.7%
3/31 • Number of events 3 • 5 years and 8.5 months
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
9.7%
3/31 • Number of events 4 • 5 years and 8.5 months
|
|
Nervous system disorders
Presyncope
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Psychiatric disorders
Anxiety
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Psychiatric disorders
Confusion
|
6.5%
2/31 • Number of events 3 • 5 years and 8.5 months
|
|
Psychiatric disorders
Insomnia
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Renal and urinary disorders
Hematuria
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
6.5%
2/31 • Number of events 2 • 5 years and 8.5 months
|
|
Renal and urinary disorders
Urinary incontinence
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Renal and urinary disorders
Urine discoloration
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Renal and urinary disorders
Cystitis noninfective
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Renal and urinary disorders
Acute kidney injury
|
6.5%
2/31 • Number of events 2 • 5 years and 8.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.5%
2/31 • Number of events 2 • 5 years and 8.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.5%
2/31 • Number of events 2 • 5 years and 8.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.5%
2/31 • Number of events 2 • 5 years and 8.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
6.5%
2/31 • Number of events 2 • 5 years and 8.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
9.7%
3/31 • Number of events 3 • 5 years and 8.5 months
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.7%
3/31 • Number of events 3 • 5 years and 8.5 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.1%
5/31 • Number of events 5 • 5 years and 8.5 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
6.5%
2/31 • Number of events 2 • 5 years and 8.5 months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
6.5%
2/31 • Number of events 2 • 5 years and 8.5 months
|
|
Vascular disorders
Hypertension
|
3.2%
1/31 • Number of events 1 • 5 years and 8.5 months
|
|
Vascular disorders
Hypotension
|
9.7%
3/31 • Number of events 3 • 5 years and 8.5 months
|
|
Vascular disorders
Vascular disorders - Other, specify
|
6.5%
2/31 • Number of events 2 • 5 years and 8.5 months
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place