Trial Outcomes & Findings for Donor Umbilical Cord Blood Transplant in Treating Patients With Hematologic Cancer (NCT NCT00723099)
NCT ID: NCT00723099
Last Updated: 2019-12-27
Results Overview
Kaplan-Meier and cumulative incidence estimates will be used.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
73 participants
Primary outcome timeframe
At 1 year
Results posted on
2019-12-27
Participant Flow
Participant milestones
| Measure |
Arm 1 and 2 Treatment
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1-2 hours on day -6.
Arm 1 (patients with lower risk of graft failure-have received multi-agent chemotherapy in the prior 2 months or history of prior autologous transplant): Patients undergo 200 cGy TBI on day -1.
Arm 2 (patients at higher risk of graft failure-have not received multi agent chemotherapy in the prior 2 months and no history of prior autologous transplant): Patients undergo 300 cGy TBI on day -1
UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo donor umbilical cord blood infusion on day 0.
IMMUNOSUPRESSIVE THERAPIES: Patients receive cyclosporine IV over 1 hour every 8-12 hours on days 0 to +180 and mycophenolate mofetil IV or PO every 8 hours on days -3 to +96.
|
|---|---|
|
Overall Study
STARTED
|
73
|
|
Overall Study
COMPLETED
|
72
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Only patients in a complete remission were assessed for minimal residual disease. All others are known to have residual disease
Baseline characteristics by cohort
| Measure |
Treatment (Chemotherapy, Transplant)
n=72 Participants
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1-2 hours on day -6.
ARM 1(patients at low risk for graft failure) - patients receive 200cGy TBI ARM 2 (patients at high risk for graft failure) - patients receive 300cGy TBI
UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo donor umbilical cord blood infusion on day 0.
IMMUNOSUPRESSIVE THERAPIES: Patients receive cyclosporine IV over 1 hour every 8-12 hours on days 0 to +180 and mycophenolate mofetil IV or PO every 8 hours on days -3 to +96.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo single or double umbilical cord blood transplant
|
|---|---|
|
Minimal Residual Disease
MRD negative
|
19 Participants
n=56 Participants • Only patients in a complete remission were assessed for minimal residual disease. All others are known to have residual disease
|
|
Minimal Residual Disease
unknown
|
1 Participants
n=56 Participants • Only patients in a complete remission were assessed for minimal residual disease. All others are known to have residual disease
|
|
Number of cord blood donors
Single Cord
|
2 Participants
n=72 Participants
|
|
Number of cord blood donors
Double Cord
|
70 Participants
n=72 Participants
|
|
Level of HLA matching
4/6 plus 4/6
|
27 Participants
n=72 Participants
|
|
Age, Continuous
|
60 years
n=72 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=72 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=72 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=72 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=72 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=72 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=72 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=72 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=72 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=72 Participants
|
|
Karnofsky Performance Scale
100
|
17 Participants
n=72 Participants
|
|
Karnofsky Performance Scale
90
|
29 Participants
n=72 Participants
|
|
Karnofsky Performance Scale
80
|
18 Participants
n=72 Participants
|
|
Karnofsky Performance Scale
70
|
6 Participants
n=72 Participants
|
|
Karnofsky Performance Scale
50
|
1 Participants
n=72 Participants
|
|
Karnofsky Performance Scale
unknown
|
1 Participants
n=72 Participants
|
|
Hematopoeitic Cell Transplant Comorbidity Index
0
|
9 Participants
n=72 Participants
|
|
Hematopoeitic Cell Transplant Comorbidity Index
1
|
5 Participants
n=72 Participants
|
|
Hematopoeitic Cell Transplant Comorbidity Index
2
|
15 Participants
n=72 Participants
|
|
Hematopoeitic Cell Transplant Comorbidity Index
3
|
15 Participants
n=72 Participants
|
|
Hematopoeitic Cell Transplant Comorbidity Index
4
|
10 Participants
n=72 Participants
|
|
Hematopoeitic Cell Transplant Comorbidity Index
5
|
5 Participants
n=72 Participants
|
|
Hematopoeitic Cell Transplant Comorbidity Index
6
|
8 Participants
n=72 Participants
|
|
Hematopoeitic Cell Transplant Comorbidity Index
7
|
2 Participants
n=72 Participants
|
|
Hematopoeitic Cell Transplant Comorbidity Index
8
|
1 Participants
n=72 Participants
|
|
Hematopoeitic Cell Transplant Comorbidity Index
unknown
|
2 Participants
n=72 Participants
|
|
Cytomegalovirus Status
CMV Seropositive
|
45 Participants
n=72 Participants
|
|
Cytomegalovirus Status
CMV Seronegative
|
26 Participants
n=72 Participants
|
|
Cytomegalovirus Status
unknown
|
1 Participants
n=72 Participants
|
|
Disease
AML
|
38 Participants
n=72 Participants
|
|
Disease
ALL
|
5 Participants
n=72 Participants
|
|
Disease
MDS
|
7 Participants
n=72 Participants
|
|
Disease
Hodgkins
|
3 Participants
n=72 Participants
|
|
Disease
Non Hodgkins Lymphoma
|
6 Participants
n=72 Participants
|
|
Disease
Peripheral T cell Lymphoma
|
3 Participants
n=72 Participants
|
|
Disease
Other
|
10 Participants
n=72 Participants
|
|
Remission Status
Complete Remission
|
56 Participants
n=72 Participants
|
|
Remission Status
Partial Remission
|
9 Participants
n=72 Participants
|
|
Remission Status
Stable Disease
|
1 Participants
n=72 Participants
|
|
Remission Status
Progressive Disease
|
6 Participants
n=72 Participants
|
|
Minimal Residual Disease
MRD positive
|
36 Participants
n=56 Participants • Only patients in a complete remission were assessed for minimal residual disease. All others are known to have residual disease
|
|
Level of HLA matching
4/6 plus 5/6
|
19 Participants
n=72 Participants
|
|
Level of HLA matching
5/6 plus 5/6
|
19 Participants
n=72 Participants
|
|
Level of HLA matching
6/6 plus 6/6
|
4 Participants
n=72 Participants
|
|
Level of HLA matching
other
|
3 Participants
n=72 Participants
|
PRIMARY outcome
Timeframe: At 1 yearKaplan-Meier and cumulative incidence estimates will be used.
Outcome measures
| Measure |
Treatment (Chemotherapy, Transplant)
n=72 Participants
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1-2 hours on day -6. Patients with low risk of graft failure (multi-agent chemotherapy in the last 3 months or history of autologous transplant) receive 200cGy TBI on day -1. Patients with high risk of graft failure receive 300 cGy TBI on day -1.
UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo donor umbilical cord blood infusion on day 0.
IMMUNOSUPRESSIVE THERAPIES: Patients receive cyclosporine IV over 1 hour every 8-12 hours on days 0 to +180 and mycophenolate mofetil IV or PO every 8 hours on days -3 to +96.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo umbilical cord blood transplant
|
|---|---|
|
Overall Survival
|
35 percent of patients
|
SECONDARY outcome
Timeframe: By day 55Outcome measures
| Measure |
Treatment (Chemotherapy, Transplant)
n=72 Participants
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1-2 hours on day -6. Patients with low risk of graft failure (multi-agent chemotherapy in the last 3 months or history of autologous transplant) receive 200cGy TBI on day -1. Patients with high risk of graft failure receive 300 cGy TBI on day -1.
UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo donor umbilical cord blood infusion on day 0.
IMMUNOSUPRESSIVE THERAPIES: Patients receive cyclosporine IV over 1 hour every 8-12 hours on days 0 to +180 and mycophenolate mofetil IV or PO every 8 hours on days -3 to +96.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo umbilical cord blood transplant
|
|---|---|
|
Median Time to ANC > 500
|
18 days
Interval 2.0 to 46.0
|
SECONDARY outcome
Timeframe: By day 55descriptive
Outcome measures
| Measure |
Treatment (Chemotherapy, Transplant)
n=72 Participants
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1-2 hours on day -6. Patients with low risk of graft failure (multi-agent chemotherapy in the last 3 months or history of autologous transplant) receive 200cGy TBI on day -1. Patients with high risk of graft failure receive 300 cGy TBI on day -1.
UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo donor umbilical cord blood infusion on day 0.
IMMUNOSUPRESSIVE THERAPIES: Patients receive cyclosporine IV over 1 hour every 8-12 hours on days 0 to +180 and mycophenolate mofetil IV or PO every 8 hours on days -3 to +96.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo umbilical cord blood transplant
|
|---|---|
|
Number of Participants With Graft Failure/Rejection
|
3 participants
|
SECONDARY outcome
Timeframe: By 6 monthsmedian and range
Outcome measures
| Measure |
Treatment (Chemotherapy, Transplant)
n=72 Participants
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1-2 hours on day -6. Patients with low risk of graft failure (multi-agent chemotherapy in the last 3 months or history of autologous transplant) receive 200cGy TBI on day -1. Patients with high risk of graft failure receive 300 cGy TBI on day -1.
UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo donor umbilical cord blood infusion on day 0.
IMMUNOSUPRESSIVE THERAPIES: Patients receive cyclosporine IV over 1 hour every 8-12 hours on days 0 to +180 and mycophenolate mofetil IV or PO every 8 hours on days -3 to +96.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo umbilical cord blood transplant
|
|---|---|
|
Time to Platelet Engraftment of > 20,000 Cells Per mm3
|
46 days
Interval 7.0 to 161.0
|
SECONDARY outcome
Timeframe: By day 100Chi-square test was used to determine percent of grade II-IV GVHD using Glucksberg criteria
Outcome measures
| Measure |
Treatment (Chemotherapy, Transplant)
n=72 Participants
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1-2 hours on day -6. Patients with low risk of graft failure (multi-agent chemotherapy in the last 3 months or history of autologous transplant) receive 200cGy TBI on day -1. Patients with high risk of graft failure receive 300 cGy TBI on day -1.
UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo donor umbilical cord blood infusion on day 0.
IMMUNOSUPRESSIVE THERAPIES: Patients receive cyclosporine IV over 1 hour every 8-12 hours on days 0 to +180 and mycophenolate mofetil IV or PO every 8 hours on days -3 to +96.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo umbilical cord blood transplant
|
|---|---|
|
Percent of Patients With Grade II-IV Acute Graft Versus Host Disease
|
67 percent of patients
|
SECONDARY outcome
Timeframe: 100 daysFischer's exact test was used to determined percent of patients with acute grade III-IV GVHD by Glucksberg criteria
Outcome measures
| Measure |
Treatment (Chemotherapy, Transplant)
n=72 Participants
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1-2 hours on day -6. Patients with low risk of graft failure (multi-agent chemotherapy in the last 3 months or history of autologous transplant) receive 200cGy TBI on day -1. Patients with high risk of graft failure receive 300 cGy TBI on day -1.
UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo donor umbilical cord blood infusion on day 0.
IMMUNOSUPRESSIVE THERAPIES: Patients receive cyclosporine IV over 1 hour every 8-12 hours on days 0 to +180 and mycophenolate mofetil IV or PO every 8 hours on days -3 to +96.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo umbilical cord blood transplant
|
|---|---|
|
Percent of Patients With Acute GVHD Grades III-IV
|
12 percent of patients
|
SECONDARY outcome
Timeframe: At 2 yearsKaplan-Meier and cumulative incidence estimates will be used to measure percent of patients with chronic GVHD by NIH consensus criteria.
Outcome measures
| Measure |
Treatment (Chemotherapy, Transplant)
n=72 Participants
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1-2 hours on day -6. Patients with low risk of graft failure (multi-agent chemotherapy in the last 3 months or history of autologous transplant) receive 200cGy TBI on day -1. Patients with high risk of graft failure receive 300 cGy TBI on day -1.
UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo donor umbilical cord blood infusion on day 0.
IMMUNOSUPRESSIVE THERAPIES: Patients receive cyclosporine IV over 1 hour every 8-12 hours on days 0 to +180 and mycophenolate mofetil IV or PO every 8 hours on days -3 to +96.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo umbilical cord blood transplant
|
|---|---|
|
Percent of Patients With Chronic GVHD
|
19 percent of patients
|
SECONDARY outcome
Timeframe: 6 monthsKaplan-Meier and cumulative incidence estimates
Outcome measures
| Measure |
Treatment (Chemotherapy, Transplant)
n=72 Participants
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1-2 hours on day -6. Patients with low risk of graft failure (multi-agent chemotherapy in the last 3 months or history of autologous transplant) receive 200cGy TBI on day -1. Patients with high risk of graft failure receive 300 cGy TBI on day -1.
UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo donor umbilical cord blood infusion on day 0.
IMMUNOSUPRESSIVE THERAPIES: Patients receive cyclosporine IV over 1 hour every 8-12 hours on days 0 to +180 and mycophenolate mofetil IV or PO every 8 hours on days -3 to +96.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo umbilical cord blood transplant
|
|---|---|
|
Percent of Patients With Non-relapse Mortality
|
21 percent of patients
|
SECONDARY outcome
Timeframe: 1 yearKaplan-Meier and cumulative incidence estimates
Outcome measures
| Measure |
Treatment (Chemotherapy, Transplant)
n=72 Participants
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1-2 hours on day -6. Patients with low risk of graft failure (multi-agent chemotherapy in the last 3 months or history of autologous transplant) receive 200cGy TBI on day -1. Patients with high risk of graft failure receive 300 cGy TBI on day -1.
UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo donor umbilical cord blood infusion on day 0.
IMMUNOSUPRESSIVE THERAPIES: Patients receive cyclosporine IV over 1 hour every 8-12 hours on days 0 to +180 and mycophenolate mofetil IV or PO every 8 hours on days -3 to +96.
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo umbilical cord blood transplant
|
|---|---|
|
Percent of Patients With Non-relapse Mortality
|
38 percent of patients
|
Adverse Events
Treatment (Chemotherapy, Transplant)
Serious events: 18 serious events
Other events: 59 other events
Deaths: 52 deaths
Serious adverse events
| Measure |
Treatment (Chemotherapy, Transplant)
n=72 participants at risk
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1-2 hours on day -6.
Patients with low risk of graft failure receive 200 cGy TBI on day -1.
Patients with high risk of graft failure receive 300 cGy TBI on day -1.
UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo donor umbilical cord blood infusion on day 0.
IMMUNOSUPRESSIVE THERAPIES: Patients receive cyclosporine IV over 1 hour every 8-12 hours on days 0 to +180 and mycophenolate mofetil IV or PO every 8 hours on days -3 to +96.
|
|---|---|
|
Nervous system disorders
Encephalopathy
|
5.6%
4/72 • Number of events 4 • 100 days
CTCAE Version 3.0
|
|
Cardiac disorders
Syncope
|
2.8%
2/72 • Number of events 2 • 100 days
CTCAE Version 3.0
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.2%
3/72 • Number of events 3 • 100 days
CTCAE Version 3.0
|
|
Respiratory, thoracic and mediastinal disorders
Diffuse Alveolar Hemorrhage
|
4.2%
3/72 • Number of events 3 • 100 days
CTCAE Version 3.0
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.4%
1/72 • Number of events 1 • 100 days
CTCAE Version 3.0
|
|
Cardiac disorders
Heart Failure
|
2.8%
2/72 • Number of events 2 • 100 days
CTCAE Version 3.0
|
|
Infections and infestations
Sepsis
|
4.2%
3/72 • Number of events 3 • 100 days
CTCAE Version 3.0
|
|
Renal and urinary disorders
Bladder Hemorrhage
|
1.4%
1/72 • Number of events 1 • 100 days
CTCAE Version 3.0
|
|
Renal and urinary disorders
Renal Failure
|
2.8%
2/72 • Number of events 2 • 100 days
CTCAE Version 3.0
|
|
Nervous system disorders
Intracerebral Hemorrhage
|
1.4%
1/72 • Number of events 1 • 100 days
CTCAE Version 3.0
|
|
Cardiac disorders
Myocardial Infarction
|
1.4%
1/72 • Number of events 1 • 100 days
CTCAE Version 3.0
|
|
Cardiac disorders
Arrythmia
|
1.4%
1/72 • Number of events 1 • 100 days
CTCAE Version 3.0
|
|
Skin and subcutaneous tissue disorders
Fever and rash
|
1.4%
1/72 • Number of events 1 • 100 days
CTCAE Version 3.0
|
|
Infections and infestations
Encephalitis
|
1.4%
1/72 • Number of events 1 • 100 days
CTCAE Version 3.0
|
|
Cardiac disorders
Hypertension
|
1.4%
1/72 • Number of events 1 • 100 days
CTCAE Version 3.0
|
Other adverse events
| Measure |
Treatment (Chemotherapy, Transplant)
n=72 participants at risk
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1-2 hours on day -6.
Patients with low risk of graft failure receive 200 cGy TBI on day -1.
Patients with high risk of graft failure receive 300 cGy TBI on day -1.
UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo donor umbilical cord blood infusion on day 0.
IMMUNOSUPRESSIVE THERAPIES: Patients receive cyclosporine IV over 1 hour every 8-12 hours on days 0 to +180 and mycophenolate mofetil IV or PO every 8 hours on days -3 to +96.
|
|---|---|
|
Immune system disorders
allergic reaction
|
2.8%
2/72 • Number of events 2 • 100 days
CTCAE Version 3.0
|
|
Blood and lymphatic system disorders
hemolysis
|
1.4%
1/72 • Number of events 1 • 100 days
CTCAE Version 3.0
|
|
Cardiac disorders
orthostatic hypotension
|
4.2%
3/72 • Number of events 3 • 100 days
CTCAE Version 3.0
|
|
Cardiac disorders
Thrombosis
|
4.2%
3/72 • Number of events 3 • 100 days
CTCAE Version 3.0
|
|
Cardiac disorders
Left ventricular function decrease
|
4.2%
3/72 • Number of events 3 • 100 days
CTCAE Version 3.0
|
|
Cardiac disorders
Troponin elevation
|
1.4%
1/72 • Number of events 1 • 100 days
CTCAE Version 3.0
|
|
Cardiac disorders
Hypotension
|
8.3%
6/72 • Number of events 6 • 100 days
CTCAE Version 3.0
|
|
Cardiac disorders
Arrythmia
|
4.2%
3/72 • Number of events 3 • 100 days
CTCAE Version 3.0
|
|
Cardiac disorders
Myocardial infarction
|
1.4%
1/72 • Number of events 1 • 100 days
CTCAE Version 3.0
|
|
Cardiac disorders
Pericarditis
|
1.4%
1/72 • Number of events 1 • 100 days
CTCAE Version 3.0
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
8/72 • Number of events 8 • 100 days
CTCAE Version 3.0
|
|
Blood and lymphatic system disorders
Hemolytic Anemia
|
1.4%
1/72 • Number of events 1 • 100 days
CTCAE Version 3.0
|
|
Renal and urinary disorders
Hemolytic Uremic syndrome
|
1.4%
1/72 • Number of events 1 • 100 days
CTCAE Version 3.0
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
16.7%
12/72 • Number of events 12 • 100 days
CTCAE Version 3.0
|
|
Hepatobiliary disorders
Hepatic Failure
|
1.4%
1/72 • Number of events 1 • 100 days
CTCAE Version 3.0
|
|
Infections and infestations
Infection-Lung
|
16.7%
12/72 • Number of events 12 • 100 days
CTCAE Version 3.0
|
|
Infections and infestations
Infection-Blood
|
15.3%
11/72 • Number of events 22 • 100 days
CTCAE Version 3.0
|
|
Infections and infestations
Infection-GU
|
16.7%
12/72 • Number of events 13 • 100 days
CTCAE Version 3.0
|
|
Infections and infestations
Infection-GI
|
8.3%
6/72 • Number of events 6 • 100 days
CTCAE Version 3.0
|
|
Infections and infestations
Infection-Oral Cavity
|
2.8%
2/72 • Number of events 3 • 100 days
CTCAE Version 3.0
|
|
Infections and infestations
Febrile Neutropenia
|
34.7%
25/72 • Number of events 26 • 100 days
CTCAE Version 3.0
|
|
Infections and infestations
Infection skin
|
2.8%
2/72 • Number of events 2 • 100 days
CTCAE Version 3.0
|
|
Infections and infestations
Infection CNS
|
2.8%
2/72 • Number of events 2 • 100 days
CTCAE Version 3.0
|
|
Infections and infestations
Infection-joint
|
1.4%
1/72 • Number of events 1 • 100 days
CTCAE Version 3.0
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
16.7%
12/72 • Number of events 17 • 100 days
CTCAE Version 3.0
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.4%
1/72 • Number of events 1 • 100 days
CTCAE Version 3.0
|
|
Renal and urinary disorders
Renal Failure
|
5.6%
4/72 • Number of events 4 • 100 days
CTCAE Version 3.0
|
|
Nervous system disorders
Encephalopathy
|
4.2%
3/72 • Number of events 3 • 100 days
CTCAE Version 3.0
|
|
Nervous system disorders
Syncope
|
1.4%
1/72 • Number of events 1 • 100 days
CTCAE Version 3.0
|
|
Nervous system disorders
seizure
|
1.4%
1/72 • Number of events 1 • 100 days
CTCAE Version 3.0
|
|
Blood and lymphatic system disorders
Diffuse Alveolar Hemorrhage
|
8.3%
6/72 • Number of events 8 • 100 days
CTCAE Version 3.0
|
|
Renal and urinary disorders
Vaginal Bleeding
|
1.4%
1/72 • Number of events 1 • 100 days
CTCAE Version 3.0
|
|
Renal and urinary disorders
Bladder Hemorrhage
|
2.8%
2/72 • Number of events 2 • 100 days
CTCAE Version 3.0
|
|
Blood and lymphatic system disorders
Coagulopathy
|
4.2%
3/72 • Number of events 3 • 100 days
CTCAE Version 3.0
|
|
Gastrointestinal disorders
Colitis
|
2.8%
2/72 • Number of events 2 • 100 days
CTCAE Version 3.0
|
|
Gastrointestinal disorders
Diarrhea
|
4.2%
3/72 • Number of events 3 • 100 days
CTCAE Version 3.0
|
|
Gastrointestinal disorders
Mucositis
|
2.8%
2/72 • Number of events 2 • 100 days
CTCAE Version 3.0
|
|
Gastrointestinal disorders
Small Bowel Obstruction
|
1.4%
1/72 • Number of events 1 • 100 days
CTCAE Version 3.0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place