Trial Outcomes & Findings for Chemotherapy, Total Body Irradiation, and Post-Transplant Cyclophosphamide in Reducing Rates of Graft Versus Host Disease in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant (NCT NCT03192397)
NCT ID: NCT03192397
Last Updated: 2026-04-14
Results Overview
Percentage of chronic GVHD of response by human leukocyte antigen (HLA) matching by cohort
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Up to 365 days
Results posted on
2026-04-14
Participant Flow
Participant milestones
| Measure |
<=50 Years of Age Cohort A
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and 50mg/m2 melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1.
STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
<=50 Years of Age Cohort B
Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1. Patients recieve 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
>50 Years of Age Cohort A -25 mg/m2 Melphalan
Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2.75 mg/m2 Patients receive 25 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
>50 Years of Age Cohort B 50 mg/m2 Melphalan
Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, Patients receive 50 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
>50 Years of Age Cohort C .75 mg/m2 Melphalan
Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, patients receive 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
1
|
3
|
6
|
22
|
|
Overall Study
COMPLETED
|
3
|
1
|
3
|
5
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chemotherapy, Total Body Irradiation, and Post-Transplant Cyclophosphamide in Reducing Rates of Graft Versus Host Disease in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant
Baseline characteristics by cohort
| Measure |
<=50 Years of Age Cohort A
n=3 Participants
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and 50mg/m2 melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1.
STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
<=50 Years of Age Cohort B
n=1 Participants
Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1. Patients recieve 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
>50 Years of Age Cohort A -25 mg/m2 Melphalan
n=3 Participants
Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2.75 mg/m2 Patients receive 25 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
>50 Years of Age Cohort B 50 mg/m2 Melphalan
n=6 Participants
Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, Patients receive 50 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
>50 Years of Age Cohort C .75 mg/m2 Melphalan
n=22 Participants
Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, patients receive 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
35.03 years
STANDARD_DEVIATION 13.0 • n=193 Participants
|
26.5 years
n=193 Participants
|
62.5 years
STANDARD_DEVIATION 6.2 • n=386 Participants
|
61.7 years
STANDARD_DEVIATION 7.0 • n=112 Participants
|
62.5 years
STANDARD_DEVIATION 13.5 • n=103 Participants
|
58.9 years
STANDARD_DEVIATION 14.9 • n=539 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
1 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
11 Participants
n=103 Participants
|
13 Participants
n=539 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
2 Participants
n=386 Participants
|
6 Participants
n=112 Participants
|
11 Participants
n=103 Participants
|
22 Participants
n=539 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
0 Participants
n=103 Participants
|
0 Participants
n=539 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
1 Participants
n=103 Participants
|
1 Participants
n=539 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
0 Participants
n=103 Participants
|
0 Participants
n=539 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
1 Participants
n=103 Participants
|
1 Participants
n=539 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=193 Participants
|
1 Participants
n=193 Participants
|
3 Participants
n=386 Participants
|
6 Participants
n=112 Participants
|
17 Participants
n=103 Participants
|
30 Participants
n=539 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
0 Participants
n=103 Participants
|
0 Participants
n=539 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
0 Participants
n=112 Participants
|
3 Participants
n=103 Participants
|
3 Participants
n=539 Participants
|
PRIMARY outcome
Timeframe: Up to 365 daysPopulation: All treated and evaluable patients
Percentage of chronic GVHD of response by human leukocyte antigen (HLA) matching by cohort
Outcome measures
| Measure |
>50 Years of Age Cohort C .75 mg/m2 Melphalan
n=22 Participants
Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, patients receive 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic stem cell transplant
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV
Sirolimus: Given IV and PO
Total-Body Irradiation: Undergo TBI
|
<=50 Years of Age Cohort A
n=3 Participants
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and 50mg/m2 melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1.
STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
<=50 Years of Age Cohort B
n=1 Participants
Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1. Patients recieve 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
>50 Years of Age Cohort A -25 mg/m2 Melphalan
n=3 Participants
Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2.75 mg/m2 Patients receive 25 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
>50 Years of Age Cohort B 50 mg/m2 Melphalan
n=6 Participants
Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, Patients receive 50 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
|---|---|---|---|---|---|
|
Extensive Chronic Graft Versus Host Disease (GVHD)
|
40.9 percentage of participants
|
66.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: All treated and evaluable patients
Patients who achieved a clinical response will be summarized descriptively using frequency counts
Outcome measures
| Measure |
>50 Years of Age Cohort C .75 mg/m2 Melphalan
n=22 Participants
Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, patients receive 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic stem cell transplant
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV
Sirolimus: Given IV and PO
Total-Body Irradiation: Undergo TBI
|
<=50 Years of Age Cohort A
n=3 Participants
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and 50mg/m2 melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1.
STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
<=50 Years of Age Cohort B
n=1 Participants
Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1. Patients recieve 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
>50 Years of Age Cohort A -25 mg/m2 Melphalan
n=3 Participants
Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2.75 mg/m2 Patients receive 25 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
>50 Years of Age Cohort B 50 mg/m2 Melphalan
n=6 Participants
Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, Patients receive 50 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
|---|---|---|---|---|---|
|
Clinical Response Assessed as Per Bone Marrow Transplant (BMT) Standard of Care
|
17 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: All treated and eligible patients
Will be analyzed in a descriptive fashion with means +/- standard deviations or frequency counts. Will examine in a post-hoc analysis potential chronic GVHD rates of response by human leukocyte antigen (HLA) matching status.
Outcome measures
| Measure |
>50 Years of Age Cohort C .75 mg/m2 Melphalan
n=22 Participants
Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, patients receive 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic stem cell transplant
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV
Sirolimus: Given IV and PO
Total-Body Irradiation: Undergo TBI
|
<=50 Years of Age Cohort A
n=3 Participants
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and 50mg/m2 melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1.
STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
<=50 Years of Age Cohort B
n=1 Participants
Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1. Patients recieve 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
>50 Years of Age Cohort A -25 mg/m2 Melphalan
n=3 Participants
Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2.75 mg/m2 Patients receive 25 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
>50 Years of Age Cohort B 50 mg/m2 Melphalan
n=6 Participants
Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, Patients receive 50 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
|---|---|---|---|---|---|
|
Cumulative Incidence of Grade III-IV Acute Graft Versus Host Disease (GVHD)
|
10 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: All treated and eligible patients
Will be analyzed in a descriptive fashion with frequency counts.
Outcome measures
| Measure |
>50 Years of Age Cohort C .75 mg/m2 Melphalan
n=22 Participants
Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, patients receive 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic stem cell transplant
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV
Sirolimus: Given IV and PO
Total-Body Irradiation: Undergo TBI
|
<=50 Years of Age Cohort A
n=3 Participants
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and 50mg/m2 melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1.
STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
<=50 Years of Age Cohort B
n=1 Participants
Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1. Patients recieve 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
>50 Years of Age Cohort A -25 mg/m2 Melphalan
n=3 Participants
Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2.75 mg/m2 Patients receive 25 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
>50 Years of Age Cohort B 50 mg/m2 Melphalan
n=6 Participants
Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, Patients receive 50 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
|---|---|---|---|---|---|
|
Cumulative Incidence of Relapse
|
11 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: All treated and eligible patients
Will be analyzed in a descriptive fashion with frequency counts.
Outcome measures
| Measure |
>50 Years of Age Cohort C .75 mg/m2 Melphalan
n=22 Participants
Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, patients receive 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic stem cell transplant
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV
Sirolimus: Given IV and PO
Total-Body Irradiation: Undergo TBI
|
<=50 Years of Age Cohort A
n=3 Participants
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and 50mg/m2 melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1.
STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
<=50 Years of Age Cohort B
n=1 Participants
Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1. Patients recieve 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
>50 Years of Age Cohort A -25 mg/m2 Melphalan
n=3 Participants
Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2.75 mg/m2 Patients receive 25 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
>50 Years of Age Cohort B 50 mg/m2 Melphalan
n=6 Participants
Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, Patients receive 50 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
|---|---|---|---|---|---|
|
Engraftment Rate Assessed as Per Bone Marrow Transplant (BMT) Standard of Care
|
16 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 4 yearsPopulation: All treated and evaluable patients
Will utilize either straight Kaplan-Meier based estimators or extensions of nonparametric survival models to account for competing risks.
Outcome measures
| Measure |
>50 Years of Age Cohort C .75 mg/m2 Melphalan
n=22 Participants
Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, patients receive 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic stem cell transplant
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV
Sirolimus: Given IV and PO
Total-Body Irradiation: Undergo TBI
|
<=50 Years of Age Cohort A
n=3 Participants
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and 50mg/m2 melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1.
STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
<=50 Years of Age Cohort B
n=1 Participants
Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1. Patients recieve 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
>50 Years of Age Cohort A -25 mg/m2 Melphalan
n=3 Participants
Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2.75 mg/m2 Patients receive 25 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
>50 Years of Age Cohort B 50 mg/m2 Melphalan
n=6 Participants
Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, Patients receive 50 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
|---|---|---|---|---|---|
|
Overall Survival Assessed as Per Bone Marrow Transplant (BMT) Standard of Care
|
NA months
Interval 6.4 to
Insufficient number of participants with events. The median and upper limit was not reached.
|
NA months
Insufficient number of participants with events. The median was not reached, there were no events.
|
NA months
Insufficient number of participants with events. The median was not reached, there were no events.
|
NA months
Insufficient number of participants with events. The median was not reached, there were no events.
|
33.5 months
Interval 1.8 to 53.3
|
SECONDARY outcome
Timeframe: At 1 yearPopulation: All treated and eligible patients
Will utilize either straight Kaplan-Meier based estimators or extensions of nonparametric survival models to account for competing risks.
Outcome measures
| Measure |
>50 Years of Age Cohort C .75 mg/m2 Melphalan
n=22 Participants
Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, patients receive 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic stem cell transplant
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV
Sirolimus: Given IV and PO
Total-Body Irradiation: Undergo TBI
|
<=50 Years of Age Cohort A
n=3 Participants
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and 50mg/m2 melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1.
STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
<=50 Years of Age Cohort B
n=1 Participants
Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1. Patients recieve 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
>50 Years of Age Cohort A -25 mg/m2 Melphalan
n=3 Participants
Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2.75 mg/m2 Patients receive 25 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
>50 Years of Age Cohort B 50 mg/m2 Melphalan
n=6 Participants
Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, Patients receive 50 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
|---|---|---|---|---|---|
|
1-Year Progression Free Survival (PFS) Rate Assessed as Per Bone Marrow Transplant (BMT) Standard of Care
|
77 percentage of participants
Interval 59.0 to 88.0
|
100 percentage of participants
Interval 100.0 to 100.0
|
100 percentage of participants
Interval 100.0 to 100.0
|
100 percentage of participants
Interval 100.0 to 100.0
|
83 percentage of participants
Interval 27.0 to 97.0
|
SECONDARY outcome
Timeframe: All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months.Population: All treated and evaluable patients
Count of participants that died by cohort.
Outcome measures
| Measure |
>50 Years of Age Cohort C .75 mg/m2 Melphalan
n=10 Participants
Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, patients receive 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic stem cell transplant
Cyclophosphamide: Given IV
Fludarabine Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
Melphalan Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV
Sirolimus: Given IV and PO
Total-Body Irradiation: Undergo TBI
|
<=50 Years of Age Cohort A
n=3 Participants
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and 50mg/m2 melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1.
STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
<=50 Years of Age Cohort B
n=1 Participants
Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1. Patients recieve 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
>50 Years of Age Cohort A -25 mg/m2 Melphalan
n=3 Participants
Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2.75 mg/m2 Patients receive 25 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
>50 Years of Age Cohort B 50 mg/m2 Melphalan
n=6 Participants
Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, Patients receive 50 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
|---|---|---|---|---|---|
|
Treatment-related Mortality Rates
|
10 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
Adverse Events
<=50 Years of Age Cohort A
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
<=50 Years of Age Cohort B
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
>50 Years of Age Cohort A -25 mg/m2 Melphalan
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
>50 Years of Age Cohort B 50 mg/m2 Melphalan
Serious events: 4 serious events
Other events: 4 other events
Deaths: 5 deaths
>50 Years of Age Cohort C .75 mg/m2 Melphalan
Serious events: 5 serious events
Other events: 20 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
<=50 Years of Age Cohort A
n=3 participants at risk
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and 50mg/m2 melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1.
STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
<=50 Years of Age Cohort B
n=1 participants at risk
Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1. Patients recieve 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
>50 Years of Age Cohort A -25 mg/m2 Melphalan
n=3 participants at risk
Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2.75 mg/m2 Patients receive 25 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
>50 Years of Age Cohort B 50 mg/m2 Melphalan
n=6 participants at risk
Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, Patients receive 50 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
>50 Years of Age Cohort C .75 mg/m2 Melphalan
n=22 participants at risk
Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, patients receive 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/22 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Cardiac disorders
Heart failure
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Colonic fistula
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
General disorders and administration site conditions
Fever
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
33.3%
2/6 • Number of events 2 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/22 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/22 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/22 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/22 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
Other adverse events
| Measure |
<=50 Years of Age Cohort A
n=3 participants at risk
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and 50mg/m2 melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1.
STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
<=50 Years of Age Cohort B
n=1 participants at risk
Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1. Patients recieve 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
>50 Years of Age Cohort A -25 mg/m2 Melphalan
n=3 participants at risk
Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2.75 mg/m2 Patients receive 25 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
>50 Years of Age Cohort B 50 mg/m2 Melphalan
n=6 participants at risk
Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, Patients receive 50 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
>50 Years of Age Cohort C .75 mg/m2 Melphalan
n=22 participants at risk
Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, patients receive 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
100.0%
3/3 • Number of events 3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
33.3%
2/6 • Number of events 2 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
40.9%
9/22 • Number of events 9 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/22 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
33.3%
2/6 • Number of events 2 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
18.2%
4/22 • Number of events 6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/22 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
13.6%
3/22 • Number of events 4 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
40.9%
9/22 • Number of events 10 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
13.6%
3/22 • Number of events 3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Esophageal pain
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
22.7%
5/22 • Number of events 8 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
40.9%
9/22 • Number of events 12 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
31.8%
7/22 • Number of events 11 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
General disorders and administration site conditions
Edema limbs
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
General disorders and administration site conditions
Fatigue
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
31.8%
7/22 • Number of events 11 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
General disorders and administration site conditions
Fever
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
9.1%
2/22 • Number of events 7 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
General disorders and administration site conditions
General disorders and administration site conditions - Other, specify
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/22 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
General disorders and administration site conditions
Neck edema
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
General disorders and administration site conditions
Localized edema
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
9.1%
2/22 • Number of events 3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Infections and infestations
Skin infection
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
13.6%
3/22 • Number of events 3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
General disorders and administration site conditions
Non-cardiac chest pain
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
General disorders and administration site conditions
Pain
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
27.3%
6/22 • Number of events 6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Investigations
Platelet count decreased
|
66.7%
2/3 • Number of events 2 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
100.0%
3/3 • Number of events 3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
33.3%
2/6 • Number of events 2 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
27.3%
6/22 • Number of events 9 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Investigations
White blood cell decreased
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
100.0%
1/1 • Number of events 2 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
13.6%
3/22 • Number of events 5 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
16.7%
1/6 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
36.4%
8/22 • Number of events 8 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Nervous system disorders
Sinus pain
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 2 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
13.6%
3/22 • Number of events 4 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
9.1%
2/22 • Number of events 2 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
9.1%
2/22 • Number of events 2 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/22 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Reproductive system and breast disorders
Genital edema
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
13.6%
3/22 • Number of events 3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
18.2%
4/22 • Number of events 4 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
9.1%
2/22 • Number of events 2 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
9.1%
2/22 • Number of events 3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
33.3%
2/6 • Number of events 2 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
9.1%
2/22 • Number of events 2 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
9.1%
2/22 • Number of events 2 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
|
Vascular disorders
Lymphedema
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/3 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
0.00%
0/6 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
4.5%
1/22 • Number of events 1 • All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm. AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place