Trial Outcomes & Findings for BEAM vs. 90-Yttrium Ibritumomab Tiuxetan (Zevalin®)/BEAM With ASCT for Relapsed DLBCL (NCT NCT02366663)
NCT ID: NCT02366663
Last Updated: 2018-03-12
Results Overview
Survival estimates will be calculated using the Kaplan-Meier method
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
3 participants
Primary outcome timeframe
Measured from randomization to date of death or last follow up date, whichever occurs first, for up to 5 years post randomization
Results posted on
2018-03-12
Participant Flow
Participant milestones
| Measure |
Arm I (ZBEAM)
Patients receive rituximab IV on days -21 and -14, and 90-yttrium ibritumomab tiuxetan IV on day -14. Patients also receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.
90-Yttrium Ibritumomab tiuxetan: 0.4 mCi/kg given IV
Carmustine: Given IV
Etoposide: Given IV
Cytarabine: Given IV
Melphalan: Given IV
Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)
Rituximab: Given IV
|
Arm II (BEAM)
Patients receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.
Carmustine: Given IV
Etoposide: Given IV
Cytarabine: Given IV
Melphalan: Given IV
Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
|
Overall Study
COMPLETED
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BEAM vs. 90-Yttrium Ibritumomab Tiuxetan (Zevalin®)/BEAM With ASCT for Relapsed DLBCL
Baseline characteristics by cohort
| Measure |
Arm I (ZBEAM)
n=2 Participants
Patients receive rituximab IV on days -21 and -14, and 90-yttrium ibritumomab tiuxetan IV on day -14. Patients also receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.
90-Yttrium Ibritumomab tiuxetan: 0.4 mCi/kg given IV
Carmustine: Given IV
Etoposide: Given IV
Cytarabine: Given IV
Melphalan: Given IV
Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)
Rituximab: Given IV
|
Arm II (BEAM)
n=1 Participants
Patients receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.
Carmustine: Given IV
Etoposide: Given IV
Cytarabine: Given IV
Melphalan: Given IV
Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
69 years
n=5 Participants
|
48 years
n=7 Participants
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured from randomization to date of death or last follow up date, whichever occurs first, for up to 5 years post randomizationPopulation: The study was terminated before the data are mature enough to estimate the survival outcome and conduct the test. Therefore, the overall number of participants analyzed is 0 in both groups.
Survival estimates will be calculated using the Kaplan-Meier method
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured from randomization until death, relapse/progression, receipt of anti-lymphoma therapy, or last follow up whichever comes first, for up to 5 years post randomizationPopulation: The study was terminated before the data are mature enough to estimate the survival outcome and conduct the test. Therefore, the overall number of participants analyzed is 0 in both groups.
Survival estimates will be calculated using the Kaplan-Meier method
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: The study was terminated before the data are mature enough to estimate the cumulative incidence and conduct the test. Therefore, the overall number of participants analyzed is 0 in both groups.
Time-to-event will be measured from the date of ASCT.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 0 to Day +30 post-HCTPopulation: In Arm I (ZBEAM), one patient's disease status at Day 30 is not available. Therefore, the overall number of participants analyzed in Arm I (ZBEAM) is 1.
Definition of disease status is based on the article of Revised Response Criteria for Malignant Lymphoma Response Definitions for Clinical Trials (Cheson et al, 2007). Tests used for evaluation of disease status would be physical examination, laboratory testing, bone marrow testing, bone marrow biopsy and aspirate, PET scan, and CT scans of neck, chest, abdomen and pelvis as indicated.
Outcome measures
| Measure |
Arm I (ZBEAM)
n=1 Participants
Patients receive rituximab IV on days -21 and -14, and 90-yttrium ibritumomab tiuxetan IV on day -14. Patients also receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.
90-Yttrium Ibritumomab tiuxetan: 0.4 mCi/kg given IV
Carmustine: Given IV
Etoposide: Given IV
Cytarabine: Given IV
Melphalan: Given IV
Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)
Rituximab: Given IV
|
Arm II (BEAM)
n=1 Participants
Patients receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.
Carmustine: Given IV
Etoposide: Given IV
Cytarabine: Given IV
Melphalan: Given IV
Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)
|
|---|---|---|
|
Number of Patients With Complete or Partial Response at Day 30
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 0 to Day 100 post-HCTPopulation: The study was terminated before the data are mature enough to estimate the cumulative incidence and conduct the test. Therefore, the descriptive analysis was performed. The median time to ANC engraftment and range are reported below.
Time to neutrophil engraftment will be compared between treatment arms using a log-rank test, and the cumulative incidence curves will be estimated.
Outcome measures
| Measure |
Arm I (ZBEAM)
n=2 Participants
Patients receive rituximab IV on days -21 and -14, and 90-yttrium ibritumomab tiuxetan IV on day -14. Patients also receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.
90-Yttrium Ibritumomab tiuxetan: 0.4 mCi/kg given IV
Carmustine: Given IV
Etoposide: Given IV
Cytarabine: Given IV
Melphalan: Given IV
Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)
Rituximab: Given IV
|
Arm II (BEAM)
n=1 Participants
Patients receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.
Carmustine: Given IV
Etoposide: Given IV
Cytarabine: Given IV
Melphalan: Given IV
Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)
|
|---|---|---|
|
Time to Neutrophil Engraftment
|
11 days
Interval 11.0 to 11.0
|
10 days
Interval 10.0 to 10.0
|
SECONDARY outcome
Timeframe: Day 0 to Day +100 post-HCTPopulation: The study was terminated before the data are mature enough to conduct the test. Therefore, the overall number of participants analyzed is 0 in both groups.
Microbiologically documented infections will be reported by site of disease, date of onset, severity, and resolution, if any. The incidence of definite and probable viral, fungal and bacterial infections will be tabulated for each patient. The proportion of patients developing infections will be compared between treatment arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization until non-disease related death, or last follow-up, whichever comes first, assessed up to 5 yearsPopulation: The study was terminated before the data are mature enough to estimate the cumulative incidence and conduct the test. Therefore, the overall number of participants analyzed is 0 in both groups.
The cumulative incidence of NRM will be estimated using the method described by Gooley et al. Differences between cumulative incidence curves in the presence of a competing risk will be tested using the Gray method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: The study was terminated before the data are mature enough to estimate the cumulative incidence and conduct the test. Therefore, the overall number of participants analyzed is 0 in both groups.
Incidence of myelodysplastic syndrome (MDS), and secondary acute Myelogenous leukemia (AML) will be compared between the treatment arms using Gray's test.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 0 to Day 100 post-HCTPopulation: The study was terminated before the data are mature enough to estimate the cumulative incidence and conduct the test. Therefore, the descriptive analysis was performed. The median time to platelet engraftment and range are reported below.
Time to platelet engraftment will be compared between treatment arms using a log-rank test, and the cumulative incidence curves will be estimated.
Outcome measures
| Measure |
Arm I (ZBEAM)
n=2 Participants
Patients receive rituximab IV on days -21 and -14, and 90-yttrium ibritumomab tiuxetan IV on day -14. Patients also receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.
90-Yttrium Ibritumomab tiuxetan: 0.4 mCi/kg given IV
Carmustine: Given IV
Etoposide: Given IV
Cytarabine: Given IV
Melphalan: Given IV
Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)
Rituximab: Given IV
|
Arm II (BEAM)
n=1 Participants
Patients receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.
Carmustine: Given IV
Etoposide: Given IV
Cytarabine: Given IV
Melphalan: Given IV
Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)
|
|---|---|---|
|
Time to Platelet Engraftment
|
22.5 days
Interval 19.0 to 26.0
|
26 days
Interval 26.0 to 26.0
|
SECONDARY outcome
Timeframe: Day -21 to Day +100 post-HCTPopulation: Number of patients with grade 3, 4 or 5 toxicities in each arm, are reported below.
Observed toxicities will be summarized in terms of type and severity. In accordance with the secondary study objectives, descriptive analyses on these data will be performed.
Outcome measures
| Measure |
Arm I (ZBEAM)
n=2 Participants
Patients receive rituximab IV on days -21 and -14, and 90-yttrium ibritumomab tiuxetan IV on day -14. Patients also receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.
90-Yttrium Ibritumomab tiuxetan: 0.4 mCi/kg given IV
Carmustine: Given IV
Etoposide: Given IV
Cytarabine: Given IV
Melphalan: Given IV
Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)
Rituximab: Given IV
|
Arm II (BEAM)
n=1 Participants
Patients receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.
Carmustine: Given IV
Etoposide: Given IV
Cytarabine: Given IV
Melphalan: Given IV
Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)
|
|---|---|---|
|
Number of Patients With Grade 3-5 Toxicities Graded by the NCI CTCAE Version 4.0
Anemia
|
2 Participants
|
1 Participants
|
|
Number of Patients With Grade 3-5 Toxicities Graded by the NCI CTCAE Version 4.0
Febrile neutropenia
|
2 Participants
|
1 Participants
|
|
Number of Patients With Grade 3-5 Toxicities Graded by the NCI CTCAE Version 4.0
Hyperglycemia
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3-5 Toxicities Graded by the NCI CTCAE Version 4.0
Hyponatremia
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3-5 Toxicities Graded by the NCI CTCAE Version 4.0
INR increased
|
1 Participants
|
0 Participants
|
|
Number of Patients With Grade 3-5 Toxicities Graded by the NCI CTCAE Version 4.0
Lymphocyte count decreased
|
2 Participants
|
1 Participants
|
|
Number of Patients With Grade 3-5 Toxicities Graded by the NCI CTCAE Version 4.0
Mucositis oral
|
2 Participants
|
1 Participants
|
|
Number of Patients With Grade 3-5 Toxicities Graded by the NCI CTCAE Version 4.0
Neutrophil count decreased
|
2 Participants
|
1 Participants
|
|
Number of Patients With Grade 3-5 Toxicities Graded by the NCI CTCAE Version 4.0
Obesity
|
1 Participants
|
1 Participants
|
|
Number of Patients With Grade 3-5 Toxicities Graded by the NCI CTCAE Version 4.0
Oral pain
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3-5 Toxicities Graded by the NCI CTCAE Version 4.0
Pharyngeal mucositis
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3-5 Toxicities Graded by the NCI CTCAE Version 4.0
Platelet count decreased
|
2 Participants
|
1 Participants
|
|
Number of Patients With Grade 3-5 Toxicities Graded by the NCI CTCAE Version 4.0
Sore Throat
|
0 Participants
|
1 Participants
|
|
Number of Patients With Grade 3-5 Toxicities Graded by the NCI CTCAE Version 4.0
White blood cell decreased
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 0 to Year 5 post-HCTPopulation: The study was terminated before the data are mature enough to estimate the cumulative incidence and conduct the test. Therefore, the overall number of participants analyzed is 0 in both groups.
The cumulative incidence of therapy related new, abnormal cytogenetics will be estimated for both groups taking into account the competing risk of death among patients who do not develop a second malignancy.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (ZBEAM)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Arm II (BEAM)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I (ZBEAM)
n=2 participants at risk
Patients receive rituximab IV on days -21 and -14, and 90-yttrium ibritumomab tiuxetan IV on day -14. Patients also receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.
90-Yttrium Ibritumomab tiuxetan: 0.4 mCi/kg given IV
Carmustine: Given IV
Etoposide: Given IV
Cytarabine: Given IV
Melphalan: Given IV
Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)
Rituximab: Given IV
|
Arm II (BEAM)
n=1 participants at risk
Patients receive BEAM comprising carmustine IV over 4 hours on day -6; cytarabine IV over 2 hours BID on days -5 to -2; etoposide IV over 1 hour BID or QD on days -5 to -2; and melphalan IV on day -1. Patients then undergo autologous hematopoietic stem cell transplant on day 0.
Carmustine: Given IV
Etoposide: Given IV
Cytarabine: Given IV
Melphalan: Given IV
Autologous Hematopoietic Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplantation (ASCT)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
2/2 • Number of events 4 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
100.0%
2/2 • Number of events 2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Cardiac disorders
Sinus bradycardia
|
50.0%
1/2 • Number of events 2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Cardiac disorders
Sinus tachycardia
|
100.0%
2/2 • Number of events 3 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
1/2 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 3 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
2/2 • Number of events 4 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Gastrointestinal disorders
Dry mouth
|
100.0%
2/2 • Number of events 3 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Gastrointestinal disorders
Dyspepsia
|
50.0%
1/2 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Gastrointestinal disorders
Dysphagia
|
100.0%
2/2 • Number of events 2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Gastrointestinal disorders
Esophageal pain
|
0.00%
0/2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Gastrointestinal disorders
Lip pain
|
50.0%
1/2 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
0.00%
0/1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Gastrointestinal disorders
Mucositis oral
|
100.0%
2/2 • Number of events 2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
2/2 • Number of events 3 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Gastrointestinal disorders
Oral pain
|
50.0%
1/2 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
2/2 • Number of events 2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
0.00%
0/1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Gastrointestinal disorders
Excessive salivation
|
50.0%
1/2 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
0.00%
0/1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
General disorders
Fatigue
|
100.0%
2/2 • Number of events 4 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
General disorders
Fever
|
100.0%
2/2 • Number of events 2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
General disorders
Pain
|
50.0%
1/2 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
General disorders
Edema limbs
|
100.0%
2/2 • Number of events 2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
0.00%
0/1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
General disorders
Mild night sweats
|
50.0%
1/2 • Number of events 2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
0.00%
0/1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Injury, poisoning and procedural complications
Bruising
|
100.0%
2/2 • Number of events 4 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
0.00%
0/1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
1/2 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
0.00%
0/1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
2/2 • Number of events 2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Investigations
Lymphocyte count decreased
|
100.0%
2/2 • Number of events 4 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Investigations
Neutrophil count decreased
|
100.0%
2/2 • Number of events 4 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 3 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Investigations
Platelet count decreased
|
100.0%
2/2 • Number of events 4 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Investigations
Weight loss
|
50.0%
1/2 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Investigations
White blood cell decreased
|
100.0%
2/2 • Number of events 4 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Metabolism and nutrition disorders
Anorexia
|
100.0%
2/2 • Number of events 4 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
1/2 • Number of events 2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
0.00%
0/1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
50.0%
1/2 • Number of events 2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
0.00%
0/1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
100.0%
2/2 • Number of events 4 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
50.0%
1/2 • Number of events 2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
0.00%
0/1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
50.0%
1/2 • Number of events 2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
0.00%
0/1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
50.0%
1/2 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
50.0%
1/2 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
50.0%
1/2 • Number of events 3 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
100.0%
2/2 • Number of events 2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
0.00%
0/1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Nervous system disorders
Dysgeusia
|
100.0%
2/2 • Number of events 2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
0.00%
0/1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Nervous system disorders
Headache
|
50.0%
1/2 • Number of events 2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Nervous system disorders
Jitteriness
|
0.00%
0/2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Psychiatric disorders
Anxiety
|
100.0%
2/2 • Number of events 3 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Psychiatric disorders
Depression
|
100.0%
2/2 • Number of events 4 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Psychiatric disorders
Hallucinaions
|
0.00%
0/2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Psychiatric disorders
Insomnia
|
50.0%
1/2 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Renal and urinary disorders
Urine discoloration
|
50.0%
1/2 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
0.00%
0/1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
100.0%
2/2 • Number of events 2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
50.0%
1/2 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
50.0%
1/2 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
0.00%
0/1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Vascular disorders
Hypertension
|
100.0%
2/2 • Number of events 4 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Ear and labyrinth disorders
Hearing impaired
|
50.0%
1/2 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
0.00%
0/1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Eye disorders
Double Vision
|
50.0%
1/2 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
0.00%
0/1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
General disorders
Edema face
|
50.0%
1/2 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
0.00%
0/1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
50.0%
1/2 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
0.00%
0/1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Metabolism and nutrition disorders
Obesity
|
100.0%
2/2 • Number of events 4 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
1/2 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
50.0%
1/2 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Nervous system disorders
Cognitive disturbance
|
50.0%
1/2 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
0.00%
0/1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Nervous system disorders
Memory impairment
|
50.0%
1/2 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
0.00%
0/1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Nervous system disorders
feeling off balance
|
50.0%
1/2 • Number of events 2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
0.00%
0/1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
50.0%
1/2 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
0.00%
0/1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
50.0%
1/2 • Number of events 2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
0.00%
0/1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Vascular disorders
Thromboembolic event
|
50.0%
1/2 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
0.00%
0/1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Investigations
Weight gain
|
50.0%
1/2 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
0.00%
0/1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
100.0%
1/1 • Number of events 2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
|
Investigations
INR increased
|
50.0%
1/2 • Number of events 2 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
0.00%
0/1 • Day -21 to Day +100
All the patients who received treatment were assessed periodically for the development of any toxicity. The toxicity rule for safety were assessed as each patient reach Day +30 post-HCT and Day +100 post-HCT. The study PIs, Statisticians and Coordinators reviewed all the Serious Adverse Event occurring in both groups of the trial on an ongoing basis.
|
Additional Information
Dr. Amrita Krishnan
City of Hope National Medical Center
Phone: 626-256-4673
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place