Trial Outcomes & Findings for A Phase I Study of NK Cell Infusion Following Allogeneic Peripheral Blood Stem Cell Transplantation From Related or Matched Unrelated Donors in Pediatric Patients With Solid Tumors and Leukemias (NCT NCT01287104)
NCT ID: NCT01287104
Last Updated: 2019-08-22
Results Overview
Participants received 2 doses of natural killer infusions within 56 days of hematopoietic stem cell transplant (HSCT).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
34 participants
Primary outcome timeframe
within 56 days of hematopoietic stem cell transplant (HSCT)
Results posted on
2019-08-22
Participant Flow
Participant milestones
| Measure |
SG1 - Patients With Related Donors at DL1 (1x10^5 Cells/kg)
All patients with related donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^5 NK cells/kg.
|
SG2 - Patients With Related Donors at DL2 (1x10^6 Cells/kg)
All patients with related donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^6 NK cells/kg.
|
SG3 - Patients With Unrelated Donors at DL1 (1x10^5 Cells/kg)
All patients with unrelated donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^5 NK cells/kg.
|
SG4 - Related Donors
All related stem cell donors who received at least one dose of filgrastim for NK cell mobilization.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
7
|
12
|
11
|
|
Overall Study
COMPLETED
|
3
|
2
|
5
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
7
|
3
|
Reasons for withdrawal
| Measure |
SG1 - Patients With Related Donors at DL1 (1x10^5 Cells/kg)
All patients with related donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^5 NK cells/kg.
|
SG2 - Patients With Related Donors at DL2 (1x10^6 Cells/kg)
All patients with related donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^6 NK cells/kg.
|
SG3 - Patients With Unrelated Donors at DL1 (1x10^5 Cells/kg)
All patients with unrelated donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^5 NK cells/kg.
|
SG4 - Related Donors
All related stem cell donors who received at least one dose of filgrastim for NK cell mobilization.
|
|---|---|---|---|---|
|
Overall Study
Patient developed progressive disease
|
1
|
1
|
3
|
2
|
|
Overall Study
Donor anaphylaxis
|
0
|
1
|
0
|
1
|
|
Overall Study
Developed GVHD or complications of BMT
|
0
|
1
|
4
|
0
|
|
Overall Study
Low donor chimerism
|
0
|
1
|
0
|
0
|
|
Overall Study
NK cells did not meet release criteria
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Phase I Study of NK Cell Infusion Following Allogeneic Peripheral Blood Stem Cell Transplantation From Related or Matched Unrelated Donors in Pediatric Patients With Solid Tumors and Leukemias
Baseline characteristics by cohort
| Measure |
SG1 - Patients With Related Donors at DL1 (1x10^5 Cells/kg)
n=4 Participants
All patients with related donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^5 NK cells/kg.
|
SG2 - Patients With Related Donors at DL2 (1x10^6 Cells/kg)
n=7 Participants
All patients with related donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^6 NK cells/kg.
|
SG3 - Patients With Unrelated Donors at DL1 (1x10^5 Cells/kg)
n=12 Participants
All patients with unrelated donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^5 NK cells/kg.
|
SG4 - Related Donors
n=11 Participants
All related stem cell donors who received at least one dose of filgrastim for NK cell mobilization.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
21 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Continuous
|
21.4 years
n=93 Participants
|
21.2 years
n=4 Participants
|
18.8 years
n=27 Participants
|
18.9 years
n=483 Participants
|
18.92 years
n=36 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
12 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
22 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
25 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
25 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
34 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: within 56 days of hematopoietic stem cell transplant (HSCT)Population: This outcome measure does not apply to donors as they did not receive the treatment intervention. Two participants in SG2 and three participants in SG3 were not analyzed because they did not receive a transplant.
Participants received 2 doses of natural killer infusions within 56 days of hematopoietic stem cell transplant (HSCT).
Outcome measures
| Measure |
SG1 - Patients With Related Donors at DL1 (1x10^5 Cells/kg)
n=4 Participants
All patients with related donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^5 NK cells/kg.
|
SG2 - Patients With Related Donors at DL2 (1x10^6 Cells/kg)
n=5 Participants
All patients with related donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^6 NK cells/kg.
|
SG3 - Patients With Unrelated Donors at DL1 (1x10^5 Cells/kg)
n=9 Participants
All patients with unrelated donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^5 NK cells/kg.
|
SG4 - Related Donors
All related stem cell donors who received at least one dose of filgrastim for NK cell mobilization.
|
|---|---|---|---|---|
|
Number of Patients Who Received 2 Doses of Natural Killer (NK) Cell Infusions
|
3 Participants
|
2 Participants
|
5 Participants
|
—
|
PRIMARY outcome
Timeframe: 100 daysPopulation: This outcome measure does not apply to donors as they did not receive the treatment intervention. Three patients in SG2 where not included because they did not receive any NK cell infusions. Four patients in SG3 were not included because they did not receive any NK cell infusions.
Donor engraftment is defined as \>95% donor lymphoid chimerism (cluster of differentiation 3+T-cells on peripheral blood).
Outcome measures
| Measure |
SG1 - Patients With Related Donors at DL1 (1x10^5 Cells/kg)
n=4 Participants
All patients with related donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^5 NK cells/kg.
|
SG2 - Patients With Related Donors at DL2 (1x10^6 Cells/kg)
n=8 Participants
All patients with related donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^6 NK cells/kg.
|
SG3 - Patients With Unrelated Donors at DL1 (1x10^5 Cells/kg)
All patients with unrelated donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^5 NK cells/kg.
|
SG4 - Related Donors
All related stem cell donors who received at least one dose of filgrastim for NK cell mobilization.
|
|---|---|---|---|---|
|
Number of Patients Who Received the Highest Dose Level of NK Cells (1x10^6 NK Cells/kg for Patients With Related Donors and 1 x10^5 NK Cells/kg for Patients With Unrelated Donors) With Sustained Donor Lymphoid Engraftment
|
1 Participants
|
5 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 3 years post-transplantPopulation: This outcome measure does not apply to donors as they did not receive the treatment intervention. Three participants in SG2 and four participants in SG3 were not analyzed because they did not receive any NK cell infusions.
Chronic graft versus host disease was assessed by the National Institutes of Health Consensus Criteria. Severity is rated mild moderate or severe on a scale of 0 (no symptoms) -3 (severe symptoms) . Mild is signs and symptoms that do not interfere substantially with function and do not progress once appropriately treated with local therapy. Moderate is signs and symptoms interfere somewhat with function despite appropriate therapy. Severe is signs and symptoms limit function substantially despite appropriate therapy. Low grade is best outcome and high grade is worse outcome.
Outcome measures
| Measure |
SG1 - Patients With Related Donors at DL1 (1x10^5 Cells/kg)
n=4 Participants
All patients with related donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^5 NK cells/kg.
|
SG2 - Patients With Related Donors at DL2 (1x10^6 Cells/kg)
n=4 Participants
All patients with related donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^6 NK cells/kg.
|
SG3 - Patients With Unrelated Donors at DL1 (1x10^5 Cells/kg)
n=8 Participants
All patients with unrelated donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^5 NK cells/kg.
|
SG4 - Related Donors
All related stem cell donors who received at least one dose of filgrastim for NK cell mobilization.
|
|---|---|---|---|---|
|
Number of Participants With Mild, Moderate and/or Severe Chronic Graft Versus Host Disease (cGVHD)
Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Mild, Moderate and/or Severe Chronic Graft Versus Host Disease (cGVHD)
Mild
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Mild, Moderate and/or Severe Chronic Graft Versus Host Disease (cGVHD)
Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 12 months post-transplantPopulation: This outcome measure does not apply to donors as they did not receive the treatment intervention. Three participants in SG2 and four participants in SG3 were not analyzed because they did not receive any NK cell infusions.
Disease free survival is defined as the time interval from start of treatment to documented evidence of disease progression. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progressive disease is at least a 20% increase in the sum of the longest diameter of all target lesions.
Outcome measures
| Measure |
SG1 - Patients With Related Donors at DL1 (1x10^5 Cells/kg)
n=4 Participants
All patients with related donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^5 NK cells/kg.
|
SG2 - Patients With Related Donors at DL2 (1x10^6 Cells/kg)
n=4 Participants
All patients with related donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^6 NK cells/kg.
|
SG3 - Patients With Unrelated Donors at DL1 (1x10^5 Cells/kg)
n=8 Participants
All patients with unrelated donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^5 NK cells/kg.
|
SG4 - Related Donors
All related stem cell donors who received at least one dose of filgrastim for NK cell mobilization.
|
|---|---|---|---|---|
|
Disease-free Survival
|
2.8 Months
Interval 1.8 to 3.1
|
8.7 Months
Interval 2.0 to 12.0
|
10.35 Months
Interval 6.2 to 12.0
|
—
|
SECONDARY outcome
Timeframe: Up to 36 months post-transplantPopulation: This outcome measure does not apply to donors as they did not undergo transplant. Three participants in SG2 and four participants in SG3 were not analyzed because they did not receive any NK cell infusions.
Overall survival is defined as the time from date of transplant until date of death or date last known alive.
Outcome measures
| Measure |
SG1 - Patients With Related Donors at DL1 (1x10^5 Cells/kg)
n=4 Participants
All patients with related donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^5 NK cells/kg.
|
SG2 - Patients With Related Donors at DL2 (1x10^6 Cells/kg)
n=4 Participants
All patients with related donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^6 NK cells/kg.
|
SG3 - Patients With Unrelated Donors at DL1 (1x10^5 Cells/kg)
n=8 Participants
All patients with unrelated donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^5 NK cells/kg.
|
SG4 - Related Donors
All related stem cell donors who received at least one dose of filgrastim for NK cell mobilization.
|
|---|---|---|---|---|
|
Overall Survival Since Date of Transplant
|
15.5 Months
Interval 5.8 to 30.2
|
34 Months
Interval 6.3 to 36.0
|
10.5 Months
Interval 6.4 to 36.0
|
—
|
SECONDARY outcome
Timeframe: Within 1-year post-transplantPopulation: This outcome measure does not apply to donors as they did not receive the treatment intervention. Three participants in SG2 and four participants in SG3 were not analyzed because they did not receive any NK cell infusions.
One or more occurrences of a new infection, reactivation or both (e.g. cytomegalovirus + flu, for example). Viral infections increase a patient's risk for a worse outcome and viral reactivation is a marker for T-cell immune dysregulation (i.e., inflammation).
Outcome measures
| Measure |
SG1 - Patients With Related Donors at DL1 (1x10^5 Cells/kg)
n=4 Participants
All patients with related donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^5 NK cells/kg.
|
SG2 - Patients With Related Donors at DL2 (1x10^6 Cells/kg)
n=4 Participants
All patients with related donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^6 NK cells/kg.
|
SG3 - Patients With Unrelated Donors at DL1 (1x10^5 Cells/kg)
n=8 Participants
All patients with unrelated donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^5 NK cells/kg.
|
SG4 - Related Donors
All related stem cell donors who received at least one dose of filgrastim for NK cell mobilization.
|
|---|---|---|---|---|
|
Number of Occurrences of Viral Infection and/or Reactivation in Allogeneic Peripheral Blood Stem Cell Transplant (PBSCT) Followed by Natural Killer-donor Lymphocyte Infusion (NK-DLI)
|
6 viral infections/reactivations
|
11 viral infections/reactivations
|
14 viral infections/reactivations
|
—
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: This outcome measure was not performed.The data was not collected for this outcome measure because the original Principal Investigator departed the institution. The protocol was transferred to a new Principal Investigator who elected not to pursue this outcome.
Cytokine levels are checked in a multiplex format according to manufacturer's instructions (Meso Scale Discovery, Gaithersburg, Maryland, United States of America (USA).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Prior to stem cell transplant (Day 0)Population: This outcome measure does not apply to donors as they did not receive the treatment intervention. Three participants in SG2 and four participants in SG3 were not analyzed because they did not receive any NK cell infusions.
Blood samples and/or buccal swabs were obtained and the presence of Killer-cell immunoglobulin-like receptors (KIR) genes was determined by locus specific polymerase chain reaction (PCR) amplification followed by gel electrophoresis. KIR receptors were examined for a mismatch in the human leukocyte antigen (HLA) ligand. A mismatch in the HLA ligand can signal increased anti-tumor activity, enhanced engraftment, and/or less infectious complications for patients.
Outcome measures
| Measure |
SG1 - Patients With Related Donors at DL1 (1x10^5 Cells/kg)
n=4 Participants
All patients with related donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^5 NK cells/kg.
|
SG2 - Patients With Related Donors at DL2 (1x10^6 Cells/kg)
n=4 Participants
All patients with related donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^6 NK cells/kg.
|
SG3 - Patients With Unrelated Donors at DL1 (1x10^5 Cells/kg)
n=8 Participants
All patients with unrelated donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^5 NK cells/kg.
|
SG4 - Related Donors
All related stem cell donors who received at least one dose of filgrastim for NK cell mobilization.
|
|---|---|---|---|---|
|
Number of Participants With Presence of Killer-cell Immunoglobulin-like Receptors (KIR) Gene Mismatch
|
3 Participants
|
2 Participants
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: Date treatment consent signed to date off study, approximately 65 months and 2 days.Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned
Outcome measures
| Measure |
SG1 - Patients With Related Donors at DL1 (1x10^5 Cells/kg)
n=4 Participants
All patients with related donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^5 NK cells/kg.
|
SG2 - Patients With Related Donors at DL2 (1x10^6 Cells/kg)
n=7 Participants
All patients with related donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^6 NK cells/kg.
|
SG3 - Patients With Unrelated Donors at DL1 (1x10^5 Cells/kg)
n=12 Participants
All patients with unrelated donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^5 NK cells/kg.
|
SG4 - Related Donors
n=11 Participants
All related stem cell donors who received at least one dose of filgrastim for NK cell mobilization.
|
|---|---|---|---|---|
|
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
|
4 Participants
|
7 Participants
|
12 Participants
|
8 Participants
|
Adverse Events
SG1 - Patients With Related Donors at DL1 (1x10^5 Cells/kg)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 4 deaths
SG2 - Patients With Related Donors at DL2 (1x10^6 Cells/kg)
Serious events: 4 serious events
Other events: 7 other events
Deaths: 6 deaths
SG3 - Patients With Unrelated Donors at DL1 (1x10^5 Cells/kg)
Serious events: 6 serious events
Other events: 12 other events
Deaths: 8 deaths
SG4 - Related Donors
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SG1 - Patients With Related Donors at DL1 (1x10^5 Cells/kg)
n=4 participants at risk
All patients with related donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^5 NK cells/kg.
|
SG2 - Patients With Related Donors at DL2 (1x10^6 Cells/kg)
n=7 participants at risk
All patients with related donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^6 NK cells/kg.
|
SG3 - Patients With Unrelated Donors at DL1 (1x10^5 Cells/kg)
n=12 participants at risk
All patients with unrelated donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^5 NK cells/kg.
|
SG4 - Related Donors
n=11 participants at risk
All related stem cell donors who received at least one dose of filgrastim for NK cell mobilization.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Immune system disorders
Anaphylaxis
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 6 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
16.7%
2/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
25.0%
3/12 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Eye disorders
Eye disorders - Other, CMV Retinitis
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
General disorders
Fever
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
16.7%
2/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Investigations
GGT increased
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Hepatobiliary disorders
Hepatic hemorrhage
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Infections and infestations
Hepatic infection
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, Liver ( GVHD)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Infections and infestations
Infections and infestations - Other, CMV reactivation
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
28.6%
2/7 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Infections and infestations
Infections and infestations - Other, PCP Pneumonia
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Infections and infestations
Infections and infestations - Other, Pneumonia
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Infections and infestations
Infections and infestations - Other, Salmonella in stool
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Infections and infestations
Infections and infestations - Other, c difficile positive
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Renal and urinary disorders
Renal hemorrhage
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, Respiratory failure
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
Other adverse events
| Measure |
SG1 - Patients With Related Donors at DL1 (1x10^5 Cells/kg)
n=4 participants at risk
All patients with related donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^5 NK cells/kg.
|
SG2 - Patients With Related Donors at DL2 (1x10^6 Cells/kg)
n=7 participants at risk
All patients with related donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^6 NK cells/kg.
|
SG3 - Patients With Unrelated Donors at DL1 (1x10^5 Cells/kg)
n=12 participants at risk
All patients with unrelated donors who received Pre-bone marrow transplant (BMT) Prep Regimen with Peripheral Blood Stem Cell infusion and at least one Natural Killer (NK) cell infusion at a dose of 1x10\^5 NK cells/kg.
|
SG4 - Related Donors
n=11 participants at risk
All related stem cell donors who received at least one dose of filgrastim for NK cell mobilization.
|
|---|---|---|---|---|
|
Investigations
CPK increased
|
25.0%
1/4 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
28.6%
2/7 • Number of events 4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
33.3%
4/12 • Number of events 4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Infections and infestations
Catheter related infection
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
28.6%
2/7 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
16.7%
2/12 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Gastrointestinal disorders
Abdominal pain
|
75.0%
3/4 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
71.4%
5/7 • Number of events 13 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
50.0%
6/12 • Number of events 13 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
18.2%
2/11 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
25.0%
1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
42.9%
3/7 • Number of events 12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
75.0%
9/12 • Number of events 16 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
25.0%
3/12 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
33.3%
4/12 • Number of events 4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Nervous system disorders
Akathisia
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Investigations
Alanine aminotransferase increased
|
75.0%
3/4 • Number of events 9 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
85.7%
6/7 • Number of events 50 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
91.7%
11/12 • Number of events 64 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
28.6%
2/7 • Number of events 4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
16.7%
2/12 • Number of events 4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
75.0%
3/4 • Number of events 5 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
42.9%
3/7 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
41.7%
5/12 • Number of events 6 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
25.0%
3/12 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Gastrointestinal disorders
Anal pain
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
4/4 • Number of events 31 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
100.0%
7/7 • Number of events 85 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
75.0%
9/12 • Number of events 108 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Metabolism and nutrition disorders
Anorexia
|
75.0%
3/4 • Number of events 4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
85.7%
6/7 • Number of events 16 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
91.7%
11/12 • Number of events 24 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Psychiatric disorders
Anxiety
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 6 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
33.3%
4/12 • Number of events 6 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
16.7%
2/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
4/4 • Number of events 15 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
71.4%
5/7 • Number of events 47 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
75.0%
9/12 • Number of events 70 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
57.1%
4/7 • Number of events 7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
50.0%
6/12 • Number of events 18 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
28.6%
2/7 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, Diffusely edematous
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, varicose veins
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Investigations
Blood bilirubin increased
|
50.0%
2/4 • Number of events 5 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
42.9%
3/7 • Number of events 19 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
41.7%
5/12 • Number of events 17 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Eye disorders
Blurred vision
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
33.3%
4/12 • Number of events 6 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
57.1%
4/7 • Number of events 7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
25.0%
3/12 • Number of events 4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Injury, poisoning and procedural complications
Bruising
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
71.4%
5/7 • Number of events 10 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
25.0%
3/12 • Number of events 4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Cardiac disorders
Chest pain - cardiac
|
25.0%
1/4 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
General disorders
Chills
|
100.0%
4/4 • Number of events 6 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
42.9%
3/7 • Number of events 5 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
50.0%
6/12 • Number of events 9 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Investigations
Cholesterol high
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
33.3%
4/12 • Number of events 4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
25.0%
3/12 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
16.7%
2/12 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
2/4 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
42.9%
3/7 • Number of events 7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
33.3%
4/12 • Number of events 8 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Eye disorders
Corneal ulcer
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
2/4 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
42.9%
3/7 • Number of events 6 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
83.3%
10/12 • Number of events 18 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Investigations
Creatinine increased
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
28.6%
2/7 • Number of events 5 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
50.0%
6/12 • Number of events 26 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
28.6%
2/7 • Number of events 4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
16.7%
2/12 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
25.0%
3/12 • Number of events 4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Psychiatric disorders
Depression
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
25.0%
3/12 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Gastrointestinal disorders
Diarrhea
|
75.0%
3/4 • Number of events 7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
57.1%
4/7 • Number of events 12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
75.0%
9/12 • Number of events 45 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
42.9%
3/7 • Number of events 6 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
41.7%
5/12 • Number of events 10 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Eye disorders
Dry eye
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
42.9%
3/7 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
25.0%
3/12 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Gastrointestinal disorders
Dry mouth
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
42.9%
3/7 • Number of events 4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
66.7%
8/12 • Number of events 9 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
57.1%
4/7 • Number of events 7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
75.0%
9/12 • Number of events 13 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Nervous system disorders
Dysarthria
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
42.9%
3/7 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
25.0%
3/12 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Gastrointestinal disorders
Dysphagia
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
33.3%
4/12 • Number of events 4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
41.7%
5/12 • Number of events 7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
General disorders
Edema face
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
16.7%
2/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
General disorders
Edema limbs
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
28.6%
2/7 • Number of events 6 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
41.7%
5/12 • Number of events 5 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
16.7%
2/12 • Number of events 4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
28.6%
2/7 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
25.0%
3/12 • Number of events 6 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Gastrointestinal disorders
Esophageal pain
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
16.7%
2/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Eye disorders
Eye disorders - Other, Amblyopia
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Eye disorders
Eye disorders - Other, double vision
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Eye disorders
Eye disorders - Other, dry eye
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Eye disorders
Eye disorders - Other, ocular GVHD
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Eye disorders
Eye disorders - Other, keratopathy
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Eye disorders
Eye pain
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
28.6%
2/7 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Eye disorders
Eyelid function disorder
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
General disorders
Fatigue
|
100.0%
4/4 • Number of events 8 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
71.4%
5/7 • Number of events 9 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
41.7%
5/12 • Number of events 10 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
General disorders
Fever
|
100.0%
4/4 • Number of events 14 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
42.9%
3/7 • Number of events 9 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
91.7%
11/12 • Number of events 88 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 8 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Vascular disorders
Flushing
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Investigations
GGT increased
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 6 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
General disorders
Gait disturbance
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
28.6%
2/7 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
25.0%
3/12 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Gastrointestinal disorders
Gastroparesis
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
16.7%
2/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
General disorders
General disorders and administration site conditions - Other, Anasarca
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
General disorders
General disorders and administration site conditions - Other, edema
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
General disorders
General disorders and administration site conditions - Other, generalized edema
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Infections and infestations
Gum infection
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Investigations
Haptoglobin decreased
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
16.7%
2/12 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Nervous system disorders
Headache
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
85.7%
6/7 • Number of events 28 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
66.7%
8/12 • Number of events 28 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
36.4%
4/11 • Number of events 5 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Vascular disorders
Hematoma
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
16.7%
2/12 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Renal and urinary disorders
Hematuria
|
50.0%
2/4 • Number of events 6 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
25.0%
3/12 • Number of events 9 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Blood and lymphatic system disorders
Hemolytic uremic syndrome
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
25.0%
3/12 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Vascular disorders
Venous occlusive disease
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, intrahepatic biliary ductal stricture
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
28.6%
2/7 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
42.9%
3/7 • Number of events 9 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
4/4 • Number of events 38 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
85.7%
6/7 • Number of events 82 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
100.0%
12/12 • Number of events 160 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
57.1%
4/7 • Number of events 8 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
33.3%
4/12 • Number of events 4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
25.0%
1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
16.7%
2/12 • Number of events 6 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
25.0%
1/4 • Number of events 4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
57.1%
4/7 • Number of events 12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
50.0%
6/12 • Number of events 22 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
25.0%
3/12 • Number of events 4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
25.0%
1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
41.7%
5/12 • Number of events 7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
25.0%
3/12 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
100.0%
4/4 • Number of events 25 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
71.4%
5/7 • Number of events 33 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
83.3%
10/12 • Number of events 92 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
100.0%
4/4 • Number of events 39 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
71.4%
5/7 • Number of events 26 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
91.7%
11/12 • Number of events 157 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
75.0%
3/4 • Number of events 9 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
25.0%
3/12 • Number of events 17 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
75.0%
3/4 • Number of events 5 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
85.7%
6/7 • Number of events 15 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
58.3%
7/12 • Number of events 45 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
71.4%
5/7 • Number of events 29 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
66.7%
8/12 • Number of events 112 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
71.4%
5/7 • Number of events 17 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
66.7%
8/12 • Number of events 29 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
100.0%
4/4 • Number of events 18 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
57.1%
4/7 • Number of events 30 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
83.3%
10/12 • Number of events 99 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Vascular disorders
Hypotension
|
50.0%
2/4 • Number of events 4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
42.9%
3/7 • Number of events 5 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
41.7%
5/12 • Number of events 14 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
25.0%
3/12 • Number of events 4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Immune system disorders
Immune system disorders - Other, red man syndrome with vanco
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Infections and infestations
Infections and infestations - Other, Adenovirus viremia
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Infections and infestations
Infections and infestations - Other, C. diff infection
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
28.6%
2/7 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Infections and infestations
Infections and infestations - Other, cytomegalovirus
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 6 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Infections and infestations
Infections and infestations - Other, E. coli bacteremia
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Infections and infestations
Infections and infestations - Other, Enterococcus faecalis
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Infections and infestations
Infections and infestations - Other, herpes zoster
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Infections and infestations
Infections and infestations - Other, Gram Positive
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Infections and infestations
Infections and infestations - Other, salmonella positive
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Infections and infestations
Infections and infestations - Other, upper respiratory infection
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
42.9%
3/7 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
33.3%
4/12 • Number of events 5 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Infections and infestations
Infections and infestations - Other, urinary tract infection
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
General disorders
Infusion related reaction
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
General disorders
Injection site reaction
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
18.2%
2/11 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
41.7%
5/12 • Number of events 7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Nervous system disorders
Intracranial hemorrhage
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Reproductive system and breast disorders
Irregular menstruation
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Investigations
Lipase increased
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
16.7%
2/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
General disorders
Localized edema
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Infections and infestations
Lung infection
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
25.0%
3/12 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Vascular disorders
Lymphedema
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
16.7%
2/12 • Number of events 14 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
General disorders
Malaise
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, bicarbonate, low
|
50.0%
2/4 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
71.4%
5/7 • Number of events 27 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
66.7%
8/12 • Number of events 54 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Infections and infestations
Mucosal infection
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Gastrointestinal disorders
Mucositis oral
|
50.0%
2/4 • Number of events 4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
71.4%
5/7 • Number of events 11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
66.7%
8/12 • Number of events 18 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
General disorders
Multi-organ failure
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, hand stiff
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, joint pain
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, muscle weakness
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
16.7%
2/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, wrist weakness bilaterally
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
50.0%
2/4 • Number of events 6 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
42.9%
3/7 • Number of events 8 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
27.3%
3/11 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Infections and infestations
Nail infection
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
16.7%
2/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
28.6%
2/7 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
16.7%
2/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
4/4 • Number of events 15 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
71.4%
5/7 • Number of events 29 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
66.7%
8/12 • Number of events 32 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
18.2%
2/11 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
28.6%
2/7 • Number of events 5 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Investigations
Neutrophil count decreased
|
100.0%
4/4 • Number of events 51 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
100.0%
7/7 • Number of events 96 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
100.0%
12/12 • Number of events 107 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
27.3%
3/11 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
25.0%
3/12 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
General disorders
Pain
|
25.0%
1/4 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
71.4%
5/7 • Number of events 24 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
50.0%
6/12 • Number of events 17 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
36.4%
4/11 • Number of events 4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
25.0%
3/12 • Number of events 5 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
28.6%
2/7 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Nervous system disorders
Paresthesia
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
33.3%
4/12 • Number of events 4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
25.0%
3/12 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Eye disorders
Periorbital edema
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
25.0%
3/12 • Number of events 4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Infections and infestations
Peritoneal infection
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Eye disorders
Photophobia
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Investigations
Platelet count decreased
|
100.0%
4/4 • Number of events 43 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
85.7%
6/7 • Number of events 97 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
100.0%
12/12 • Number of events 239 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
54.5%
6/11 • Number of events 10 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
28.6%
2/7 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
41.7%
5/12 • Number of events 5 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Gastrointestinal disorders
Proctitis
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
16.7%
2/12 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Renal and urinary disorders
Proteinuria
|
75.0%
3/4 • Number of events 12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
28.6%
2/7 • Number of events 4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
41.7%
5/12 • Number of events 45 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
50.0%
2/4 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
71.4%
5/7 • Number of events 13 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
58.3%
7/12 • Number of events 16 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
16.7%
2/12 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
50.0%
2/4 • Number of events 4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
57.1%
4/7 • Number of events 9 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
75.0%
9/12 • Number of events 43 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
42.9%
3/7 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
41.7%
5/12 • Number of events 6 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, bladder spasm intermittent
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, renal proximal tubular damage
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, trouble maintaining urinary stream
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, urethral irritation
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, cough
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, pulmonary infiltrates
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Eye disorders
Retinal vascular disorder
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Infections and infestations
Rhinitis infective
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Eye disorders
Scleral disorder
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
16.7%
2/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Investigations
Serum amylase increased
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
16.7%
2/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
25.0%
3/12 • Number of events 5 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Cardiac disorders
Sinus tachycardia
|
75.0%
3/4 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
71.4%
5/7 • Number of events 7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
58.3%
7/12 • Number of events 9 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Infections and infestations
Sinusitis
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
28.6%
2/7 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
16.7%
2/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, erythema
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, genital lesion
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Erythema surrounding Hickman
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, hyperkeratotic papules
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
25.0%
3/12 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Infections and infestations
Soft tissue infection
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
25.0%
3/12 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
28.6%
2/7 • Number of events 4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
50.0%
6/12 • Number of events 9 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
42.9%
3/7 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
16.7%
2/12 • Number of events 4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Vascular disorders
Superficial thrombophlebitis
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, inguinal pain on surgical site
|
25.0%
1/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, jaw inflammation (S/P extraction)
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, pain in the biliary drain
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, bleeding from ETT
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
28.6%
2/7 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Nervous system disorders
Tremor
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
16.7%
2/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Gastrointestinal disorders
Typhlitis
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Renal and urinary disorders
Urinary frequency
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
25.0%
3/12 • Number of events 4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Renal and urinary disorders
Urinary tract pain
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
25.0%
3/12 • Number of events 4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Investigations
Urine output decreased
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
16.7%
2/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Injury, poisoning and procedural complications
Urostomy obstruction
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Reproductive system and breast disorders
Vaginal dryness
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Reproductive system and breast disorders
Vaginal pain
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
4/4 • Number of events 11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
71.4%
5/7 • Number of events 20 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
75.0%
9/12 • Number of events 28 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Eye disorders
Watering eyes
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Investigations
Weight gain
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Investigations
Weight loss
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
28.6%
2/7 • Number of events 9 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
75.0%
9/12 • Number of events 63 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Investigations
White blood cell decreased
|
100.0%
4/4 • Number of events 65 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
85.7%
6/7 • Number of events 97 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
100.0%
12/12 • Number of events 176 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
27.3%
3/11 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Cardiac disorders
Electrocardiogram QT corrected prolonged
|
25.0%
1/4 • Number of events 4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
14.3%
1/7 • Number of events 3 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Ear and labyrinth disorders
Otitis externa
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Infections and infestations
Infections and Infestations - Other, Bacteremia
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
28.6%
2/7 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
25.0%
3/12 • Number of events 5 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Skin and subcutaneous tissue disorders
Papulopustular rash
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
8.3%
1/12 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Investigations
Alkaline aminotransferase
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
57.1%
4/7 • Number of events 11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
41.7%
5/12 • Number of events 14 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
18.2%
2/11 • Number of events 2 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/7 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/12 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
100.0%
4/4 • Number of events 5 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
71.4%
5/7 • Number of events 6 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
50.0%
6/12 • Number of events 8 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
0.00%
0/11 • Date treatment consent signed to date off study, approximately 65 months and 2 days.
The majority of participants listed in All-Cause Mortality died from progressive disease. There were two patients who died from transplant-related complications.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place