Trial Outcomes & Findings for Conditioning Regimen of Bendamustine and Melphalan Followed by Transplant in Patients With Multiple Myeloma (NCT NCT00916058)
NCT ID: NCT00916058
Last Updated: 2019-06-04
Results Overview
The Maximum Tolerated Dose was not met in Phase 1 of the study. Phase 2 participants were enrolled at the highest dose administered in Phase 1 (Dose Level 6) and this Outcome Measure is the reported number of dose-limiting toxicities experienced by Phase 1 participants. DLTs were defined as any grade 3 non-hematologic adverse even that did not resolve within 72 hours, any occurrence of a grade 4 non-hematologic adverse event, or failure to engraft with an absolute neutrophil count of 500/mm\^3 and platelet count of 20,000/mm\^3 untransfused by Day 35 post-transplant.
COMPLETED
PHASE1/PHASE2
57 participants
35 days post-transplant
2019-06-04
Participant Flow
Four subjects were ineligible and therefore never started treatment.
Participant milestones
| Measure |
Dose Level 1
Dose Level 1; Bendamustine 30 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 30 mg/m2 given on day 2 of melphalan
Melphalan: 100 mg/m2 for 2 days (70 mg/m2 for patients with Creatinine Clearance \<70 ml/min)
|
Dose Level 2
Dose Level 2; Bendamustine 60 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m2 for 2 days (70 mg/m2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 60 mg/m2 given on the 2nd day of melphalan
|
Dose Level 3
Dose Level 3; Bendamustine 90 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m2 for 2 days (70 mg/m2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 90 mg/m2 given on the 2nd day of melphalan
|
Dose Level 4
Dose Level 4; Bendamustine 120 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m2 for 2 days (70 mg/m2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 60 mg/m2 given on the 1st and 2nd day of melphalan
|
Dose Level 5
Dose Level 5; Bendamustine 150 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m2 for 2 days (70 mg/m2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 90 mg/m2 given on the 1st day of melphalan and 60 mg/m2 given on the 2nd day of melphalan
|
Dose Level 6
Dose Level 6; Bendamustine 225 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m2 for 2 days (70 mg/m2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 125 mg/m2 given on the 1st day of melphalan and 100mg/m2 given on the 2nd day of melphalan
|
Phase 2
Bendamustine 225 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m2 for 2 days (70 mg/m2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 125 mg/m2 given on the 1st day of melphalan and 100mg/m2 given on the 2nd day of melphalan
|
|---|---|---|---|---|---|---|---|
|
Phase 1
STARTED
|
3
|
6
|
3
|
3
|
3
|
8
|
0
|
|
Phase 1
COMPLETED
|
3
|
6
|
3
|
3
|
3
|
7
|
0
|
|
Phase 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Phase 2
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
31
|
|
Phase 2
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
28
|
|
Phase 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
Dose Level 1
Dose Level 1; Bendamustine 30 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 30 mg/m2 given on day 2 of melphalan
Melphalan: 100 mg/m2 for 2 days (70 mg/m2 for patients with Creatinine Clearance \<70 ml/min)
|
Dose Level 2
Dose Level 2; Bendamustine 60 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m2 for 2 days (70 mg/m2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 60 mg/m2 given on the 2nd day of melphalan
|
Dose Level 3
Dose Level 3; Bendamustine 90 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m2 for 2 days (70 mg/m2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 90 mg/m2 given on the 2nd day of melphalan
|
Dose Level 4
Dose Level 4; Bendamustine 120 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m2 for 2 days (70 mg/m2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 60 mg/m2 given on the 1st and 2nd day of melphalan
|
Dose Level 5
Dose Level 5; Bendamustine 150 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m2 for 2 days (70 mg/m2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 90 mg/m2 given on the 1st day of melphalan and 60 mg/m2 given on the 2nd day of melphalan
|
Dose Level 6
Dose Level 6; Bendamustine 225 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m2 for 2 days (70 mg/m2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 125 mg/m2 given on the 1st day of melphalan and 100mg/m2 given on the 2nd day of melphalan
|
Phase 2
Bendamustine 225 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m2 for 2 days (70 mg/m2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 125 mg/m2 given on the 1st day of melphalan and 100mg/m2 given on the 2nd day of melphalan
|
|---|---|---|---|---|---|---|---|
|
Phase 1
Screen Failure
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Phase 2
Screen Failure
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
Baseline Characteristics
Conditioning Regimen of Bendamustine and Melphalan Followed by Transplant in Patients With Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Dose Level 1
n=3 Participants
Bendamustine 30 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance \<70 ml/min)
|
Dose Level 2
n=6 Participants
Bendamustine 60 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance \<70 ml/min)
|
Dose Level 3
n=3 Participants
Bendamustine 90 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance \<70 ml/min)
|
Dose Level 4
n=3 Participants
Bendamustine 120 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance \<70 ml/min)
|
Dose Level 5
n=3 Participants
Bendamustine 150 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance \<70 ml/min)
|
Dose Level 6
n=7 Participants
Bendamustine 225 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance \<70 ml/min)
|
Phase 2
n=28 Participants
Bendamustine 225 mg/m2 total, Melphalan 200 mg/m2 total (140 mg/m2 total for patients with Creatinine Clearance \<70 ml/min)
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
56 years
n=5 Participants
|
54.5 years
n=7 Participants
|
58 years
n=5 Participants
|
62 years
n=4 Participants
|
53 years
n=21 Participants
|
55 years
n=8 Participants
|
61 years
n=8 Participants
|
59 years
n=24 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
26 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
27 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
24 Participants
n=8 Participants
|
40 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
24 Participants
n=8 Participants
|
43 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 35 days post-transplantPopulation: Phase 1 includes all patients enrolled and treated on Phase 1 of the study (Dose Levels 1 through 6).
The Maximum Tolerated Dose was not met in Phase 1 of the study. Phase 2 participants were enrolled at the highest dose administered in Phase 1 (Dose Level 6) and this Outcome Measure is the reported number of dose-limiting toxicities experienced by Phase 1 participants. DLTs were defined as any grade 3 non-hematologic adverse even that did not resolve within 72 hours, any occurrence of a grade 4 non-hematologic adverse event, or failure to engraft with an absolute neutrophil count of 500/mm\^3 and platelet count of 20,000/mm\^3 untransfused by Day 35 post-transplant.
Outcome measures
| Measure |
Dose Level 1
n=3 Participants
Dose Level 1; Bendamustine 30 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 30 mg/m\^2 given on day 2 of melphalan
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m2 for patients with Creatinine Clearance \<70 ml/min)
|
Dose Level 2
n=6 Participants
Dose Level 2; Bendamustine 60 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 60 mg/m\^2 given on the 2nd day of melphalan
|
Dose Level 3
n=3 Participants
Dose Level 3; Bendamustine 90 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 90 mg/m\^2 given on the 2nd day of melphalan
|
Dose Level 4
n=3 Participants
Dose Level 4; Bendamustine 120 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 60 mg/m\^2 given on the 1st and 2nd day of melphalan
|
Dose Level 5
n=3 Participants
Dose Level 5; Bendamustine 150 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 90 mg/m\^2 given on the 1st day of melphalan and 60 mg/m\^2 given on the 2nd day of melphalan
|
Dose Level 6
n=7 Participants
Dose Level 6; Bendamustine 225 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 125 mg/m\^2 given on the 1st day of melphalan and 100mg/m\^2 given on the 2nd day of melphalan
|
|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (Phase 1)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 100 days post-transplantPopulation: Phase 2 includes all patients treated on phase 2 of the study (28 patients), and patients treated at Dose Level 6 of the Phase 1 portion of the study (7 patients). The dose level used during Phase 2 was Dose Level 6.
Number of patients achieving at least a partial response or better in disease status at Day 100 post-transplant, as defined by the International Myeloma Working Group (IMWG) disease response criteria. Partial response in disease status is defined by the IMWG as ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to \<200 mg per 24 hours; If the serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria; If serum and urine M-protein are unmeasurable, and serum-free light assay is also unmeasurable, ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma-cell percentage was ≥30%. In addition to these criteria, if present at baseline, a ≥50% reduction in the size (SPD) of soft tissue plasmacytomas is also required
Outcome measures
| Measure |
Dose Level 1
n=35 Participants
Dose Level 1; Bendamustine 30 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 30 mg/m\^2 given on day 2 of melphalan
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m2 for patients with Creatinine Clearance \<70 ml/min)
|
Dose Level 2
Dose Level 2; Bendamustine 60 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 60 mg/m\^2 given on the 2nd day of melphalan
|
Dose Level 3
Dose Level 3; Bendamustine 90 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 90 mg/m\^2 given on the 2nd day of melphalan
|
Dose Level 4
Dose Level 4; Bendamustine 120 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 60 mg/m\^2 given on the 1st and 2nd day of melphalan
|
Dose Level 5
Dose Level 5; Bendamustine 150 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 90 mg/m\^2 given on the 1st day of melphalan and 60 mg/m\^2 given on the 2nd day of melphalan
|
Dose Level 6
Dose Level 6; Bendamustine 225 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 125 mg/m\^2 given on the 1st day of melphalan and 100mg/m\^2 given on the 2nd day of melphalan
|
|---|---|---|---|---|---|---|
|
Overall Response Rate (Phase 2) - Number of Participants Achieving at Least a Partial Response or Better in Disease Status at Day 100 Post-transplant
|
33 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 0 to first incidence of disease progression, up to 1,128 daysPopulation: Phase 1 includes all patients treated on Phase 1 of the study (Dose Levels 1-6). All cohorts were evaluated as one group for assessment of progression-free survival (PFS), as PFS is a secondary endpoint and there was no intent to stratify by cohort for the analysis. The number of patients per cohort is also too small for to evaluate by cohort.
Time elapsed between Day 0 and disease progression, as defined by the International Myeloma Working Group (IMWG) disease response criteria. Disease progression is defined as an increase of \>25% from lowest response value in any one or more of the following: * Serum M-component and/or (the absolute increase must be \> 0.5 g/dL) * Urine M-component and/or (the absolute increase must be \> 200 mg/24 h) * Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved free light chain levels. The absolute increase must be \> 10 mg/dL * Bone marrow plasma cell percentage; the absolute percentage must be \> 10% * Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas * Development of hypercalcaemia (corrected serum calcium \> 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder
Outcome measures
| Measure |
Dose Level 1
n=25 Participants
Dose Level 1; Bendamustine 30 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 30 mg/m\^2 given on day 2 of melphalan
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m2 for patients with Creatinine Clearance \<70 ml/min)
|
Dose Level 2
Dose Level 2; Bendamustine 60 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 60 mg/m\^2 given on the 2nd day of melphalan
|
Dose Level 3
Dose Level 3; Bendamustine 90 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 90 mg/m\^2 given on the 2nd day of melphalan
|
Dose Level 4
Dose Level 4; Bendamustine 120 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 60 mg/m\^2 given on the 1st and 2nd day of melphalan
|
Dose Level 5
Dose Level 5; Bendamustine 150 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 90 mg/m\^2 given on the 1st day of melphalan and 60 mg/m\^2 given on the 2nd day of melphalan
|
Dose Level 6
Dose Level 6; Bendamustine 225 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 125 mg/m\^2 given on the 1st day of melphalan and 100mg/m\^2 given on the 2nd day of melphalan
|
|---|---|---|---|---|---|---|
|
Progression-Free Survival (Phase 1)
|
791 Days
Interval 351.0 to
Upper limit not estimable
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 0 to first incidence of disease progression, up to 86 monthsPopulation: Phase 2 includes all patients treated on phase 2 of the study (28 patients), and patients treated at Dose Level 6 of the Phase 1 portion of the study (7 patients). The dose level used during Phase 2 was Dose Level 6.
Time elapsed between Day 0 and disease progression, as defined by the International Myeloma Working Group (IMWG) disease response criteria. Disease progression is defined as an increase of \>25% from lowest response value in any one or more of the following: * Serum M-component and/or (the absolute increase must be \> 0.5 g/dL) * Urine M-component and/or (the absolute increase must be \> 200 mg/24 h) * Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved free light chain levels. The absolute increase must be \> 10 mg/dL * Bone marrow plasma cell percentage; the absolute percentage must be \> 10% * Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas * Development of hypercalcaemia (corrected serum calcium \> 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder
Outcome measures
| Measure |
Dose Level 1
n=35 Participants
Dose Level 1; Bendamustine 30 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 30 mg/m\^2 given on day 2 of melphalan
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m2 for patients with Creatinine Clearance \<70 ml/min)
|
Dose Level 2
Dose Level 2; Bendamustine 60 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 60 mg/m\^2 given on the 2nd day of melphalan
|
Dose Level 3
Dose Level 3; Bendamustine 90 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 90 mg/m\^2 given on the 2nd day of melphalan
|
Dose Level 4
Dose Level 4; Bendamustine 120 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 60 mg/m\^2 given on the 1st and 2nd day of melphalan
|
Dose Level 5
Dose Level 5; Bendamustine 150 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 90 mg/m\^2 given on the 1st day of melphalan and 60 mg/m\^2 given on the 2nd day of melphalan
|
Dose Level 6
Dose Level 6; Bendamustine 225 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 125 mg/m\^2 given on the 1st day of melphalan and 100mg/m\^2 given on the 2nd day of melphalan
|
|---|---|---|---|---|---|---|
|
Progression-Free Survival (Phase 2)
|
47 Months
Interval 34.0 to
Upper limit was not estimable
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 0 until time of death, assessed up to 2 years.Population: Phase 1 includes all patients treated on Phase 1 of the study (Dose Levels 1-6). All cohorts were evaluated as one group for assessment of overall survival, as overall survival is a secondary endpoint and there was no intent to stratify by cohort for the analysis. The number of patients per cohort is also too small for to evaluate by cohort.
Time elapsed between Day 0 and death from any cause, whichever came first, assessed up to 2 years.
Outcome measures
| Measure |
Dose Level 1
n=25 Participants
Dose Level 1; Bendamustine 30 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 30 mg/m\^2 given on day 2 of melphalan
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m2 for patients with Creatinine Clearance \<70 ml/min)
|
Dose Level 2
Dose Level 2; Bendamustine 60 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 60 mg/m\^2 given on the 2nd day of melphalan
|
Dose Level 3
Dose Level 3; Bendamustine 90 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 90 mg/m\^2 given on the 2nd day of melphalan
|
Dose Level 4
Dose Level 4; Bendamustine 120 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 60 mg/m\^2 given on the 1st and 2nd day of melphalan
|
Dose Level 5
Dose Level 5; Bendamustine 150 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 90 mg/m\^2 given on the 1st day of melphalan and 60 mg/m\^2 given on the 2nd day of melphalan
|
Dose Level 6
Dose Level 6; Bendamustine 225 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 125 mg/m\^2 given on the 1st day of melphalan and 100mg/m\^2 given on the 2nd day of melphalan
|
|---|---|---|---|---|---|---|
|
Overall Survival at 2 Years (Phase 1)
|
70 Percentage of participants alive
Interval 43.9 to 85.7
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 0 until time of death, assessed up to 3 years.Population: Phase 2 includes all patients treated on phase 2 of the study (28 patients), and patients treated at Dose Level 6 of the Phase 1 portion of the study (7 patients). The dose level used during Phase 2 was Dose Level 6.
Time elapsed between Day 0 and death from any cause, whichever came first, assessed up to 3 years.
Outcome measures
| Measure |
Dose Level 1
n=35 Participants
Dose Level 1; Bendamustine 30 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 30 mg/m\^2 given on day 2 of melphalan
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m2 for patients with Creatinine Clearance \<70 ml/min)
|
Dose Level 2
Dose Level 2; Bendamustine 60 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 60 mg/m\^2 given on the 2nd day of melphalan
|
Dose Level 3
Dose Level 3; Bendamustine 90 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 90 mg/m\^2 given on the 2nd day of melphalan
|
Dose Level 4
Dose Level 4; Bendamustine 120 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 60 mg/m\^2 given on the 1st and 2nd day of melphalan
|
Dose Level 5
Dose Level 5; Bendamustine 150 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 90 mg/m\^2 given on the 1st day of melphalan and 60 mg/m\^2 given on the 2nd day of melphalan
|
Dose Level 6
Dose Level 6; Bendamustine 225 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 125 mg/m\^2 given on the 1st day of melphalan and 100mg/m\^2 given on the 2nd day of melphalan
|
|---|---|---|---|---|---|---|
|
Overall Survival at 3 Years (Phase 2)
|
88 Percentage of participants alive
Interval 72.0 to 95.0
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Dose Level 1
Dose Level 2
Dose Level 3
Dose Level 4
Dose Level 5
Dose Level 6
Phase 2
Serious adverse events
| Measure |
Dose Level 1
n=3 participants at risk
Dose Level 1; Bendamustine 30 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 30 mg/m\^2 given on day 2 of melphalan
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
|
Dose Level 2
n=6 participants at risk
Dose Level 2; Bendamustine 60 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 60 mg/m\^2 given on the 2nd day of melphalan
|
Dose Level 3
n=3 participants at risk
Dose Level 3; Bendamustine 90 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 90 mg/m\^2 given on the 2nd day of melphalan
|
Dose Level 4
n=3 participants at risk
Dose Level 4; Bendamustine 120 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 60 mg/m\^2 given on the 1st and 2nd day of melphalan
|
Dose Level 5
n=3 participants at risk
Dose Level 5; Bendamustine 150 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 90 mg/m\^2 given on the 1st day of melphalan and 60 mg/m\^2 given on the 2nd day of melphalan
|
Dose Level 6
n=7 participants at risk
Dose Level 6; Bendamustine 225 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 125 mg/m\^2 given on the 1st day of melphalan and 100mg/m\^2 given on the 2nd day of melphalan
|
Phase 2
n=28 participants at risk
Bendamustine 225 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 125 mg/m\^2 given on the 1st day of melphalan and 100mg/m\^2 given on the 2nd day of melphalan
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/28 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/28 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
General disorders
Fever
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
7.1%
2/28 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Infections and infestations
Infections and Infestations - Pneumonia
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
Other adverse events
| Measure |
Dose Level 1
n=3 participants at risk
Dose Level 1; Bendamustine 30 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 30 mg/m\^2 given on day 2 of melphalan
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
|
Dose Level 2
n=6 participants at risk
Dose Level 2; Bendamustine 60 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 60 mg/m\^2 given on the 2nd day of melphalan
|
Dose Level 3
n=3 participants at risk
Dose Level 3; Bendamustine 90 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 90 mg/m\^2 given on the 2nd day of melphalan
|
Dose Level 4
n=3 participants at risk
Dose Level 4; Bendamustine 120 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 60 mg/m\^2 given on the 1st and 2nd day of melphalan
|
Dose Level 5
n=3 participants at risk
Dose Level 5; Bendamustine 150 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 90 mg/m\^2 given on the 1st day of melphalan and 60 mg/m\^2 given on the 2nd day of melphalan
|
Dose Level 6
n=7 participants at risk
Dose Level 6; Bendamustine 225 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 125 mg/m\^2 given on the 1st day of melphalan and 100mg/m\^2 given on the 2nd day of melphalan
|
Phase 2
n=28 participants at risk
Bendamustine 225 mg/m\^2 total, Melphalan 200 mg/m\^2 total (140 mg/m\^2 total for patients with Creatinine Clearance \<70 ml/min)
Melphalan: 100 mg/m\^2 for 2 days (70 mg/m\^2 for patients with Creatinine Clearance \<70 ml/min)
Bendamustine: 125 mg/m\^2 given on the 1st day of melphalan and 100mg/m\^2 given on the 2nd day of melphalan
|
|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
66.7%
4/6 • Number of events 4 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
66.7%
2/3 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
42.9%
3/7 • Number of events 3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
50.0%
14/28 • Number of events 14 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
46.4%
13/28 • Number of events 13 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Cardiac disorders
Palpitations
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
7.1%
2/28 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Cardiac disorders
Peripheral Edema
|
33.3%
1/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
66.7%
2/3 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
28.6%
2/7 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
46.4%
13/28 • Number of events 13 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
14.3%
1/7 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
28.6%
8/28 • Number of events 8 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
53.6%
15/28 • Number of events 15 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Gastrointestinal disorders
Anorexia
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
66.7%
4/6 • Number of events 4 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
66.7%
2/3 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
66.7%
2/3 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
66.7%
2/3 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
71.4%
5/7 • Number of events 5 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
42.9%
12/28 • Number of events 12 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
10.7%
3/28 • Number of events 3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
66.7%
2/3 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
14.3%
1/7 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
50.0%
14/28 • Number of events 14 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
2/3 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
100.0%
6/6 • Number of events 6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
100.0%
3/3 • Number of events 3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
100.0%
3/3 • Number of events 3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
100.0%
3/3 • Number of events 3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
71.4%
5/7 • Number of events 5 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
92.9%
26/28 • Number of events 26 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
2/6 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
66.7%
2/3 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
14.3%
1/7 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
71.4%
20/28 • Number of events 20 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
66.7%
4/6 • Number of events 4 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
66.7%
2/3 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
42.9%
3/7 • Number of events 3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
25.0%
7/28 • Number of events 7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
10.7%
3/28 • Number of events 3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
10.7%
3/28 • Number of events 3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Gastrointestinal disorders
Mucositis Oral
|
100.0%
3/3 • Number of events 3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
100.0%
6/6 • Number of events 6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
66.7%
2/3 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
100.0%
3/3 • Number of events 3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
100.0%
3/3 • Number of events 3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
85.7%
6/7 • Number of events 6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
53.6%
15/28 • Number of events 15 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
66.7%
4/6 • Number of events 4 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
100.0%
3/3 • Number of events 3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
100.0%
3/3 • Number of events 3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
100.0%
3/3 • Number of events 3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
100.0%
7/7 • Number of events 7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
96.4%
27/28 • Number of events 27 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
7.1%
2/28 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
66.7%
4/6 • Number of events 4 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
100.0%
3/3 • Number of events 3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
66.7%
2/3 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
42.9%
3/7 • Number of events 3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
60.7%
17/28 • Number of events 17 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
General disorders
Chills
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
28.6%
8/28 • Number of events 8 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
83.3%
5/6 • Number of events 5 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
66.7%
2/3 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
100.0%
3/3 • Number of events 3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
57.1%
4/7 • Number of events 4 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
96.4%
27/28 • Number of events 27 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
General disorders
Fever
|
66.7%
2/3 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
50.0%
3/6 • Number of events 3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
66.7%
2/3 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
57.1%
4/7 • Number of events 4 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
25.0%
7/28 • Number of events 7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Infections and infestations
Catheter-Related Infection
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
10.7%
3/28 • Number of events 3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Infections and infestations
Oral Thrush
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
2/6 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
17.9%
5/28 • Number of events 5 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Infections and infestations
Upper Respiratory Infection
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
14.3%
1/7 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
10.7%
3/28 • Number of events 3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Investigations
Alkaline Phopshatase Increased
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
10.7%
3/28 • Number of events 3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Investigations
Weight Loss
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
21.4%
6/28 • Number of events 6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
14.3%
4/28 • Number of events 4 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
10.7%
3/28 • Number of events 3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
14.3%
1/7 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
14.3%
4/28 • Number of events 4 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
100.0%
7/7 • Number of events 7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
92.9%
26/28 • Number of events 26 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
100.0%
7/7 • Number of events 7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
92.9%
26/28 • Number of events 26 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
7.1%
2/28 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
2/6 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
57.1%
4/7 • Number of events 4 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
35.7%
10/28 • Number of events 10 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
42.9%
3/7 • Number of events 3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
35.7%
10/28 • Number of events 10 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Metabolism and nutrition disorders
Hypophospohatemia
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
14.3%
1/7 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
25.0%
7/28 • Number of events 7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Metabolism and nutrition disorders
Tumor Lysis Syndrome
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
7.1%
2/28 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
66.7%
2/3 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
2/6 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
66.7%
2/3 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
28.6%
2/7 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
25.0%
7/28 • Number of events 7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
14.3%
4/28 • Number of events 4 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Pain
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
14.3%
1/7 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
10.7%
3/28 • Number of events 3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
14.3%
1/7 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
32.1%
9/28 • Number of events 9 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
66.7%
2/3 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
50.0%
3/6 • Number of events 3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
66.7%
2/3 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
32.1%
9/28 • Number of events 9 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
7.1%
2/28 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
28.6%
2/7 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
28.6%
8/28 • Number of events 8 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
66.7%
2/3 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
14.3%
1/7 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
32.1%
9/28 • Number of events 9 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
42.9%
3/7 • Number of events 3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
17.9%
5/28 • Number of events 5 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
7.1%
2/28 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Nervous system disorders
Peripheral Neuropathy
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
66.7%
2/3 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
28.6%
2/7 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
7.1%
2/28 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
7.1%
2/28 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
7.1%
2/28 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
2/6 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
14.3%
1/7 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
14.3%
4/28 • Number of events 4 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
10.7%
3/28 • Number of events 3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
35.7%
10/28 • Number of events 10 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
14.3%
1/7 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
25.0%
7/28 • Number of events 7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
7.1%
2/28 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dry Cough
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
42.9%
3/7 • Number of events 3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
14.3%
4/28 • Number of events 4 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
66.7%
2/3 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
14.3%
1/7 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
64.3%
18/28 • Number of events 18 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
10.7%
3/28 • Number of events 3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
14.3%
1/7 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
7.1%
2/28 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
25.0%
7/28 • Number of events 7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
10.7%
3/28 • Number of events 3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
7.1%
2/28 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Skin and subcutaneous tissue disorders
Maculopapular Rash
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
2/6 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
66.7%
2/3 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
14.3%
1/7 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
28.6%
8/28 • Number of events 8 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
14.3%
1/7 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
14.3%
4/28 • Number of events 4 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
28.6%
2/7 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
7.1%
2/28 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
2/6 • Number of events 2 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
14.3%
1/7 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
21.4%
6/28 • Number of events 6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Eye disorders
Blurred Vision
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/28 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/28 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
14.3%
1/7 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/28 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Vascular disorders
Flushing
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/28 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/28 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
14.3%
1/7 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/28 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Infections and infestations
Infections and infestations - Rotavirus Enteritis
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/28 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Infections and infestations
Infections and Infestations - Tinea cruris
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/28 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Infections and infestations
Infections and Infestations - Streptococcus mitis Bacteremia
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/28 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Infections and infestations
Infections and Infestations - Tinea pedia
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
14.3%
1/7 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/28 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Infections and infestations
Infections and Infestations - Pneumonia
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
14.3%
1/7 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/28 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Infections and infestations
Infections and Infestations - Escherichia coli Bacteremia
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/28 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Infections and infestations
Infections and Infestations - Clostridium difficile Colitis
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/28 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Infections and infestations
Infections and Infestations - Microsporidia Enteritis
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/28 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Eye disorders
Eye Disorders - Blepharitis
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/28 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
14.3%
1/7 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/28 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Nipple Sensitivity
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/6 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/3 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/7 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
0.00%
0/28 • Adverse events were assessed Day -2 through Day 100 post-transplant. All-Cause Morality was assessed for up to 2 years for Phase 2, and 3 years for Phase 2.
All adverse events were first documented by the study transplant physicians and thereafter collated and graded by two independent reviewed according to CTCAE version 4.0.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place