Trial Outcomes & Findings for A Research Study of Bone Marrow Transplantation From Unrelated or Partially Matched Related Donors (NCT NCT01349101)
NCT ID: NCT01349101
Last Updated: 2025-12-15
Results Overview
Successful Hematopoietic engraftment will be assessed by determining the incidence of participants who achieve both of the following criteria within the 100 days post-transplant: ANC \>/= 0.5x10e9/L for at least 3 days. Platelet engraftment \>20,000 with no transfusions X 7 days. The incidence will be calculated as the number of participants who meet both engraftment criteria. Results will be presented as a proportion/percentage/probability not as an incidence rate.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
78 participants
Primary outcome timeframe
Through 100 days post-transplant
Results posted on
2025-12-15
Participant Flow
Participant milestones
| Measure |
Myeloablative HSCT
Myeloablative Hematopoietic Stem Cell Transplantation (HSCT): Patients will receive myeloablative transplants or nonmyeloablative transplants depending on their disease type.
Total Body Irradiation: Myeloablative HSCT Arm: Total body irradiation (TBI) is given in 8 fractions over 4 days (total dose of 12 Gy)
Cyclophosphamide: Cyclophosphamide is administered on the third day after the hematopoietic stem cell transplantation (HSCT) to help reduce graft-versus-host disease (GVHD). It is given at a dose of 60 mg/kg/d for 2 days on days +3 and +4.
Tacrolimus: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Mycophenolate mofetil: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Hematopoietic stem cell transplantation: Allogeneic marrow transplantation given after the last dose of total body irradiation (TBI)
|
Reduced Intensity HSCT
Reduced Intensity Hematopoietic Stem Cell Transplantation (HSCT): Patients who have received a previous transplant, patients who have received dose limiting radiation, and patients with a DLCO \<45% will receive the reduced intensity conditioning regimen.
Total Body Irradiation: Reduced Intensity HSCT Arm: TBI is given in one fraction (total dose of 2 Gy)
Cyclophosphamide: Cyclophosphamide is administered on the third day after the hematopoietic stem cell transplantation (HSCT) to help reduce graft-versus-host disease (GVHD). It is given at a dose of 60 mg/kg/d for 2 days on days +3 and +4.
Tacrolimus: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Mycophenolate mofetil: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Fludarabine: Started the fifth day before the transplant. Given for four days at 30 mg/m2/d.
Busulfan: Started the fourth day before the transplant. Given for two days at 3.2 mg/kg.
Hematopoietic stem cell transplantation: Allogeneic marrow transplantation given after the last dose of total body irradiation (TBI)
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
45
|
|
Overall Study
COMPLETED
|
29
|
36
|
|
Overall Study
NOT COMPLETED
|
4
|
9
|
Reasons for withdrawal
| Measure |
Myeloablative HSCT
Myeloablative Hematopoietic Stem Cell Transplantation (HSCT): Patients will receive myeloablative transplants or nonmyeloablative transplants depending on their disease type.
Total Body Irradiation: Myeloablative HSCT Arm: Total body irradiation (TBI) is given in 8 fractions over 4 days (total dose of 12 Gy)
Cyclophosphamide: Cyclophosphamide is administered on the third day after the hematopoietic stem cell transplantation (HSCT) to help reduce graft-versus-host disease (GVHD). It is given at a dose of 60 mg/kg/d for 2 days on days +3 and +4.
Tacrolimus: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Mycophenolate mofetil: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Hematopoietic stem cell transplantation: Allogeneic marrow transplantation given after the last dose of total body irradiation (TBI)
|
Reduced Intensity HSCT
Reduced Intensity Hematopoietic Stem Cell Transplantation (HSCT): Patients who have received a previous transplant, patients who have received dose limiting radiation, and patients with a DLCO \<45% will receive the reduced intensity conditioning regimen.
Total Body Irradiation: Reduced Intensity HSCT Arm: TBI is given in one fraction (total dose of 2 Gy)
Cyclophosphamide: Cyclophosphamide is administered on the third day after the hematopoietic stem cell transplantation (HSCT) to help reduce graft-versus-host disease (GVHD). It is given at a dose of 60 mg/kg/d for 2 days on days +3 and +4.
Tacrolimus: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Mycophenolate mofetil: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Fludarabine: Started the fifth day before the transplant. Given for four days at 30 mg/m2/d.
Busulfan: Started the fourth day before the transplant. Given for two days at 3.2 mg/kg.
Hematopoietic stem cell transplantation: Allogeneic marrow transplantation given after the last dose of total body irradiation (TBI)
|
|---|---|---|
|
Overall Study
Disease Progression
|
1
|
1
|
|
Overall Study
Death
|
3
|
8
|
Baseline Characteristics
A Research Study of Bone Marrow Transplantation From Unrelated or Partially Matched Related Donors
Baseline characteristics by cohort
| Measure |
Myeloablative HSCT
n=33 Participants
Myeloablative Hematopoietic Stem Cell Transplantation (HSCT): Patients will receive myeloablative transplants or nonmyeloablative transplants depending on their disease type.
Total Body Irradiation: Myeloablative HSCT Arm: Total body irradiation (TBI) is given in 8 fractions over 4 days (total dose of 12 Gy)
Cyclophosphamide: Cyclophosphamide is administered on the third day after the hematopoietic stem cell transplantation (HSCT) to help reduce graft-versus-host disease (GVHD). It is given at a dose of 60 mg/kg/d for 2 days on days +3 and +4.
Tacrolimus: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Mycophenolate mofetil: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Hematopoietic stem cell transplantation: Allogeneic marrow transplantation given after the last dose of total body irradiation (TBI)
|
Reduced Intensity HSCT
n=45 Participants
Reduced Intensity Hematopoietic Stem Cell Transplantation (HSCT): Patients who have received a previous transplant, patients who have received dose limiting radiation, and patients with a DLCO \<45% will receive the reduced intensity conditioning regimen.
Total Body Irradiation: Reduced Intensity HSCT Arm: TBI is given in one fraction (total dose of 2 Gy)
Cyclophosphamide: Cyclophosphamide is administered on the third day after the hematopoietic stem cell transplantation (HSCT) to help reduce graft-versus-host disease (GVHD). It is given at a dose of 60 mg/kg/d for 2 days on days +3 and +4.
Tacrolimus: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Mycophenolate mofetil: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Fludarabine: Started the fifth day before the transplant. Given for four days at 30 mg/m2/d.
Busulfan: Started the fourth day before the transplant. Given for two days at 3.2 mg/kg.
Hematopoietic stem cell transplantation: Allogeneic marrow transplantation given after the last dose of total body irradiation (TBI)
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=6009 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=77 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=6009 Participants
|
17 Participants
n=42 Participants
|
50 Participants
n=77 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=6009 Participants
|
28 Participants
n=42 Participants
|
28 Participants
n=77 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=6009 Participants
|
21 Participants
n=42 Participants
|
38 Participants
n=77 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=6009 Participants
|
24 Participants
n=42 Participants
|
40 Participants
n=77 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=6009 Participants
|
1 Participants
n=42 Participants
|
6 Participants
n=77 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=6009 Participants
|
44 Participants
n=42 Participants
|
72 Participants
n=77 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6009 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=77 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=6009 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=77 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=6009 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=77 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6009 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=77 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=6009 Participants
|
5 Participants
n=42 Participants
|
10 Participants
n=77 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=6009 Participants
|
38 Participants
n=42 Participants
|
59 Participants
n=77 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=6009 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=77 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=6009 Participants
|
0 Participants
n=42 Participants
|
7 Participants
n=77 Participants
|
PRIMARY outcome
Timeframe: Through 100 days post-transplantSuccessful Hematopoietic engraftment will be assessed by determining the incidence of participants who achieve both of the following criteria within the 100 days post-transplant: ANC \>/= 0.5x10e9/L for at least 3 days. Platelet engraftment \>20,000 with no transfusions X 7 days. The incidence will be calculated as the number of participants who meet both engraftment criteria. Results will be presented as a proportion/percentage/probability not as an incidence rate.
Outcome measures
| Measure |
Myeloablative HSCT
n=33 Participants
Myeloablative Hematopoietic Stem Cell Transplantation (HSCT): Patients will receive myeloablative transplants or nonmyeloablative transplants depending on their disease type.
Total Body Irradiation: Myeloablative HSCT Arm: Total body irradiation (TBI) is given in 8 fractions over 4 days (total dose of 12 Gy)
Reduced Intensity HSCT Arm: TBI is given in one fraction (total dose of 2 Gy)
Cyclophosphamide: Cyclophosphamide is administered on the third day after the hematopoietic stem cell transplantation (HSCT) to help reduce graft-versus-host disease (GVHD). It is given at a dose of 60 mg/kg/d for 2 days on days +3 and +4.
Tacrolimus: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Mycophenolate mofetil: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Hematopoietic stem cell transplantation: Allogeneic marrow transplantation given after the last dose of total body irradiation (TBI)
|
Reduced Intensity HSCT
n=45 Participants
Reduced Intensity Hematopoietic Stem Cell Transplantation (HSCT): Patients who have received a previous transplant, patients who have received dose limiting radiation, and patients with a DLCO \<45% will receive the reduced intensity conditioning regimen.
Total Body Irradiation: Reduced Intensity HSCT Arm: TBI is given in one fraction (total dose of 2 Gy)
Cyclophosphamide: Cyclophosphamide is administered on the third day after the hematopoietic stem cell transplantation (HSCT) to help reduce graft-versus-host disease (GVHD). It is given at a dose of 60 mg/kg/d for 2 days on days +3 and +4.
Tacrolimus: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Mycophenolate mofetil: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Fludarabine: Started the fifth day before the transplant. Given for four days at 30 mg/m2/d.
Busulfan: Started the fourth day before the transplant. Given for two days at 3.2 mg/kg.
Hematopoietic stem cell transplantation: Allogeneic marrow transplantation given after the last dose of total body irradiation (TBI)
|
|---|---|---|
|
Successful Engraftment Using Cyclophosphamide Post-Transplant
|
1.00 Cumulative Probability of Engraftment
Interval 1.0 to 1.0
|
0.93 Cumulative Probability of Engraftment
Interval 0.86 to 1.0
|
SECONDARY outcome
Timeframe: Through 100 days post-transplantThe cumulative incidence of Grade III-IV graft-versus-host disease (GVHD) within 100 days post-transplant will be estimated; goal is less than 10%. The cumulative incidence represents the probability that a participant experiences Grade III-IV GVHD by day 100. Results will be reported as proportion/percentage/probability.
Outcome measures
| Measure |
Myeloablative HSCT
n=33 Participants
Myeloablative Hematopoietic Stem Cell Transplantation (HSCT): Patients will receive myeloablative transplants or nonmyeloablative transplants depending on their disease type.
Total Body Irradiation: Myeloablative HSCT Arm: Total body irradiation (TBI) is given in 8 fractions over 4 days (total dose of 12 Gy)
Reduced Intensity HSCT Arm: TBI is given in one fraction (total dose of 2 Gy)
Cyclophosphamide: Cyclophosphamide is administered on the third day after the hematopoietic stem cell transplantation (HSCT) to help reduce graft-versus-host disease (GVHD). It is given at a dose of 60 mg/kg/d for 2 days on days +3 and +4.
Tacrolimus: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Mycophenolate mofetil: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Hematopoietic stem cell transplantation: Allogeneic marrow transplantation given after the last dose of total body irradiation (TBI)
|
Reduced Intensity HSCT
n=45 Participants
Reduced Intensity Hematopoietic Stem Cell Transplantation (HSCT): Patients who have received a previous transplant, patients who have received dose limiting radiation, and patients with a DLCO \<45% will receive the reduced intensity conditioning regimen.
Total Body Irradiation: Reduced Intensity HSCT Arm: TBI is given in one fraction (total dose of 2 Gy)
Cyclophosphamide: Cyclophosphamide is administered on the third day after the hematopoietic stem cell transplantation (HSCT) to help reduce graft-versus-host disease (GVHD). It is given at a dose of 60 mg/kg/d for 2 days on days +3 and +4.
Tacrolimus: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Mycophenolate mofetil: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Fludarabine: Started the fifth day before the transplant. Given for four days at 30 mg/m2/d.
Busulfan: Started the fourth day before the transplant. Given for two days at 3.2 mg/kg.
Hematopoietic stem cell transplantation: Allogeneic marrow transplantation given after the last dose of total body irradiation (TBI)
|
|---|---|---|
|
Cumulative Incidence of Grade III-IV GVHD
|
0.5152 Cumulative Probability of Grade III-IV G
Interval 0.3312 to 0.6716
|
0.3111 Cumulative Probability of Grade III-IV G
Interval 0.182 to 0.4493
|
SECONDARY outcome
Timeframe: Through 100 days post-treatmentThis outcome will estimate the cumulative incidence (probability) of graft-versus-host disease (GVHD) that is considered unresponsive to corticosteroids and photopheresis within 100 days after treatment; goal is less than 15%. The cumulative incidence will be calculated as the number of participants meeting these criteria. Results will be reported as a proportion/percentage.
Outcome measures
| Measure |
Myeloablative HSCT
n=33 Participants
Myeloablative Hematopoietic Stem Cell Transplantation (HSCT): Patients will receive myeloablative transplants or nonmyeloablative transplants depending on their disease type.
Total Body Irradiation: Myeloablative HSCT Arm: Total body irradiation (TBI) is given in 8 fractions over 4 days (total dose of 12 Gy)
Reduced Intensity HSCT Arm: TBI is given in one fraction (total dose of 2 Gy)
Cyclophosphamide: Cyclophosphamide is administered on the third day after the hematopoietic stem cell transplantation (HSCT) to help reduce graft-versus-host disease (GVHD). It is given at a dose of 60 mg/kg/d for 2 days on days +3 and +4.
Tacrolimus: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Mycophenolate mofetil: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Hematopoietic stem cell transplantation: Allogeneic marrow transplantation given after the last dose of total body irradiation (TBI)
|
Reduced Intensity HSCT
n=45 Participants
Reduced Intensity Hematopoietic Stem Cell Transplantation (HSCT): Patients who have received a previous transplant, patients who have received dose limiting radiation, and patients with a DLCO \<45% will receive the reduced intensity conditioning regimen.
Total Body Irradiation: Reduced Intensity HSCT Arm: TBI is given in one fraction (total dose of 2 Gy)
Cyclophosphamide: Cyclophosphamide is administered on the third day after the hematopoietic stem cell transplantation (HSCT) to help reduce graft-versus-host disease (GVHD). It is given at a dose of 60 mg/kg/d for 2 days on days +3 and +4.
Tacrolimus: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Mycophenolate mofetil: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Fludarabine: Started the fifth day before the transplant. Given for four days at 30 mg/m2/d.
Busulfan: Started the fourth day before the transplant. Given for two days at 3.2 mg/kg.
Hematopoietic stem cell transplantation: Allogeneic marrow transplantation given after the last dose of total body irradiation (TBI)
|
|---|---|---|
|
Incidence of GVHD Unresponsive to Corticosteroids and Photopheresis
|
0.0625 Cumulative Probability of GVHD
Interval 0.0107 to 0.1838
|
0.0233 Cumulative Probability of GVHD
Interval 0.00177 to 0.1072
|
SECONDARY outcome
Timeframe: 100 days post-transplantThe cumulative incidence of transplant related mortality (TRM) by day 100 post-transplant will be estimated. Assess day 100 transplant-related mortality; goal is less than 15%. TRM is defined as death that results from medical treatment rather than from the underlying disease itself. The cumulative incidence reflects the probability of TRM by day 100. The result will be reported as a proportion/percentage/probability, not an incidence rate.
Outcome measures
| Measure |
Myeloablative HSCT
n=33 Participants
Myeloablative Hematopoietic Stem Cell Transplantation (HSCT): Patients will receive myeloablative transplants or nonmyeloablative transplants depending on their disease type.
Total Body Irradiation: Myeloablative HSCT Arm: Total body irradiation (TBI) is given in 8 fractions over 4 days (total dose of 12 Gy)
Reduced Intensity HSCT Arm: TBI is given in one fraction (total dose of 2 Gy)
Cyclophosphamide: Cyclophosphamide is administered on the third day after the hematopoietic stem cell transplantation (HSCT) to help reduce graft-versus-host disease (GVHD). It is given at a dose of 60 mg/kg/d for 2 days on days +3 and +4.
Tacrolimus: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Mycophenolate mofetil: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Hematopoietic stem cell transplantation: Allogeneic marrow transplantation given after the last dose of total body irradiation (TBI)
|
Reduced Intensity HSCT
n=45 Participants
Reduced Intensity Hematopoietic Stem Cell Transplantation (HSCT): Patients who have received a previous transplant, patients who have received dose limiting radiation, and patients with a DLCO \<45% will receive the reduced intensity conditioning regimen.
Total Body Irradiation: Reduced Intensity HSCT Arm: TBI is given in one fraction (total dose of 2 Gy)
Cyclophosphamide: Cyclophosphamide is administered on the third day after the hematopoietic stem cell transplantation (HSCT) to help reduce graft-versus-host disease (GVHD). It is given at a dose of 60 mg/kg/d for 2 days on days +3 and +4.
Tacrolimus: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Mycophenolate mofetil: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Fludarabine: Started the fifth day before the transplant. Given for four days at 30 mg/m2/d.
Busulfan: Started the fourth day before the transplant. Given for two days at 3.2 mg/kg.
Hematopoietic stem cell transplantation: Allogeneic marrow transplantation given after the last dose of total body irradiation (TBI)
|
|---|---|---|
|
Transplant-Related Mortality
|
0.0909 Cumulative Probability of Mortality
Interval 0.0226 to 0.2192
|
0.1951 Cumulative Probability of Mortality
Interval 0.0904 to 0.3292
|
Adverse Events
Myeloablative HSCT
Serious events: 5 serious events
Other events: 33 other events
Deaths: 3 deaths
Reduced Intensity HSCT
Serious events: 5 serious events
Other events: 45 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Myeloablative HSCT
n=33 participants at risk
Myeloablative Hematopoietic Stem Cell Transplantation (HSCT): Patients will receive myeloablative transplants or nonmyeloablative transplants depending on their disease type.
Total Body Irradiation: Myeloablative HSCT Arm: Total body irradiation (TBI) is given in 8 fractions over 4 days (total dose of 12 Gy)
Cyclophosphamide: Cyclophosphamide is administered on the third day after the hematopoietic stem cell transplantation (HSCT) to help reduce graft-versus-host disease (GVHD). It is given at a dose of 60 mg/kg/d for 2 days on days +3 and +4.
Tacrolimus: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Mycophenolate mofetil: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Hematopoietic stem cell transplantation: Allogeneic marrow transplantation given after the last dose of total body irradiation (TBI)
|
Reduced Intensity HSCT
n=45 participants at risk
Reduced Intensity Hematopoietic Stem Cell Transplantation (HSCT): Patients who have received a previous transplant, patients who have received dose limiting radiation, and patients with a DLCO \<45% will receive the reduced intensity conditioning regimen.
Total Body Irradiation: Reduced Intensity HSCT Arm: TBI is given in one fraction (total dose of 2 Gy)
Cyclophosphamide: Cyclophosphamide is administered on the third day after the hematopoietic stem cell transplantation (HSCT) to help reduce graft-versus-host disease (GVHD). It is given at a dose of 60 mg/kg/d for 2 days on days +3 and +4.
Tacrolimus: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Mycophenolate mofetil: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Fludarabine: Started the fifth day before the transplant. Given for four days at 30 mg/m2/d.
Busulfan: Started the fourth day before the transplant. Given for two days at 3.2 mg/kg.
Hematopoietic stem cell transplantation: Allogeneic marrow transplantation given after the last dose of total body irradiation (TBI)
|
|---|---|---|
|
General disorders
Depressed Level of Consciousness - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Diarrhea -Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Diarrhea - Grade 3
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Hepatobiliary disorders
Elevated Liver Function Tests - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Emesis - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Emesis - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Failure to thrive - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Fatigue - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Immune system disorders
Fever - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Immune system disorders
Fever - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Immune system disorders
Fever - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Hypervolemia - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
Fungal Infection - Grade 4
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
Fungal PNA Nodules - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Nausea - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Blood and lymphatic system disorders
Graft rejection - Grade 4
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Ear and labyrinth disorders
Hearing impaired - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Heart failure - Grade 4
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Hematuria - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
HHV-6 Infection - Grade 4
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Musculoskeletal and connective tissue disorders
Singultus - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Hepatobiliary disorders
Hyperbilirubinemia - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Hepatobiliary disorders
Hyperbilirubinemia - Grade 4
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Hypervolemia - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Hypotension - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Hypotension - Grade 4
|
3.0%
1/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
8.9%
4/45 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
|
Reproductive system and breast disorders
Hypoxia - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia - Grade 3
|
15.2%
5/33 • Number of events 5 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia - Grade 4
|
3.0%
1/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Increased Acute Rheumatic Fever - Grade 4
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
increased creatinine - Grade 4
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
Hepatobiliary disorders
Increased Liver Function Tests - Grade 4
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Psychiatric disorders
Mental Status Change - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
Mucositis - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Acute Kidney Injury - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Acute Kidney Injury - Grade 4
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
11.1%
5/45 • Number of events 5 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
Adenovirus - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Psychiatric disorders
altered mental status - grade 4
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Angioedema - Grade 4
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Arterial Thrombosis - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Atrial Fibrillation - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Atrial Fibrillation - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Atrioventricular block complete - grade 4
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
BK Viremia - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Hepatobiliary disorders
Blood bilirubin increased - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
Candidemia - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Cardiomyopathy - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
CMV Reactivation - Grade 4
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
CMV Viremia - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Psychiatric disorders
Confusion - Grade 4
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Creatinine increased - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Cystitis - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Immune system disorders
Cytokine Release Syndrome - Grade 4
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Decreased Ejection Fraction - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Blood and lymphatic system disorders
Delayed engraftment - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Multisystem organ failure - Grade 4
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Multisystem organ failure - Grade 5
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Abdominal - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Right lower quadrant - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
Pneumonitis - Grade 3
|
9.1%
3/33 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
8.9%
4/45 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
Pneumonitis - Grade 4
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Blood and lymphatic system disorders
Poor engraftment - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Infiltrates - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Infiltrates - Grade 4
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Pulseless electrical activity - Grade 5
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure - Grade 4
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure - Grade 5
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Nervous system disorders
Seizure - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
Sepsis - Grade 4
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
Sepsis - Grade 5
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Immune system disorders
Slow engraftment - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Nervous system disorders
Stroke - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Nervous system disorders
Syncope - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
8.9%
4/45 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
|
Blood and lymphatic system disorders
Thrombocytopenia - Grade 4
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
Urinary Tract Infection - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
Fungal Infection - Grade 5
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - chills - Grade 4
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - fever - Grade 4
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - Hives - Grade 4
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - hypotension - Grade 4
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - Hypoxia - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - Pruritus - Grade 4
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - tachycardia - Grade 4
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Pneumonitis - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Intracranial hemorrhage - Grade 5
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Labial lesion - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - labial - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Edema - Labia - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Weakness - Lower extremity - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Left Ventricular Systolic Dysfunction - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
Lung Infection - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
Meningitis - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Blood and lymphatic system disorders
Blood and Lymphatic System Disorders - Other - Grade 5
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Heart Failure - Grade 5
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
Other adverse events
| Measure |
Myeloablative HSCT
n=33 participants at risk
Myeloablative Hematopoietic Stem Cell Transplantation (HSCT): Patients will receive myeloablative transplants or nonmyeloablative transplants depending on their disease type.
Total Body Irradiation: Myeloablative HSCT Arm: Total body irradiation (TBI) is given in 8 fractions over 4 days (total dose of 12 Gy)
Cyclophosphamide: Cyclophosphamide is administered on the third day after the hematopoietic stem cell transplantation (HSCT) to help reduce graft-versus-host disease (GVHD). It is given at a dose of 60 mg/kg/d for 2 days on days +3 and +4.
Tacrolimus: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Mycophenolate mofetil: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Hematopoietic stem cell transplantation: Allogeneic marrow transplantation given after the last dose of total body irradiation (TBI)
|
Reduced Intensity HSCT
n=45 participants at risk
Reduced Intensity Hematopoietic Stem Cell Transplantation (HSCT): Patients who have received a previous transplant, patients who have received dose limiting radiation, and patients with a DLCO \<45% will receive the reduced intensity conditioning regimen.
Total Body Irradiation: Reduced Intensity HSCT Arm: TBI is given in one fraction (total dose of 2 Gy)
Cyclophosphamide: Cyclophosphamide is administered on the third day after the hematopoietic stem cell transplantation (HSCT) to help reduce graft-versus-host disease (GVHD). It is given at a dose of 60 mg/kg/d for 2 days on days +3 and +4.
Tacrolimus: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Mycophenolate mofetil: Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
Fludarabine: Started the fifth day before the transplant. Given for four days at 30 mg/m2/d.
Busulfan: Started the fourth day before the transplant. Given for two days at 3.2 mg/kg.
Hematopoietic stem cell transplantation: Allogeneic marrow transplantation given after the last dose of total body irradiation (TBI)
|
|---|---|---|
|
Gastrointestinal disorders
Anal fistula - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Anasarca - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Angina pectoris - Grade 1
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Angina pectoris - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Psychiatric disorders
Anorexia - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
11.1%
5/45 • Number of events 5 • Adverse events were recorded for 100 days following transplant.
|
|
Psychiatric disorders
Anorexia - Grade 2
|
18.2%
6/33 • Number of events 6 • Adverse events were recorded for 100 days following transplant.
|
17.8%
8/45 • Number of events 8 • Adverse events were recorded for 100 days following transplant.
|
|
Psychiatric disorders
Anorexia - Grade 3
|
15.2%
5/33 • Number of events 5 • Adverse events were recorded for 100 days following transplant.
|
11.1%
5/45 • Number of events 5 • Adverse events were recorded for 100 days following transplant.
|
|
Psychiatric disorders
Anxiety - Grade 1
|
27.3%
9/33 • Number of events 10 • Adverse events were recorded for 100 days following transplant.
|
33.3%
15/45 • Number of events 18 • Adverse events were recorded for 100 days following transplant.
|
|
Psychiatric disorders
Anxiety - Grade 2
|
45.5%
15/33 • Number of events 15 • Adverse events were recorded for 100 days following transplant.
|
37.8%
17/45 • Number of events 18 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Aphthous ulcer - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Musculoskeletal and connective tissue disorders
Abdominal Distention - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
Musculoskeletal and connective tissue disorders
Abdominal Distention - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Abnormal DLCO test - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Abrasion - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Acute Kidney Injury - Grade 1
|
15.2%
5/33 • Number of events 6 • Adverse events were recorded for 100 days following transplant.
|
20.0%
9/45 • Number of events 10 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Acute Kidney Injury - Grade 2
|
9.1%
3/33 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Acidosis - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Psychiatric disorders
Agitation - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Psychiatric disorders
Agitation - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
8.9%
4/45 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
|
Psychiatric disorders
Agitation - Grade 4
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Hepatobiliary disorders
Alanine aminotransferase increased - Grade 2
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Hepatobiliary disorders
Alanine phosphatase increased - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Immune system disorders
Allergic rhinitis - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Blood and lymphatic system disorders
Alloimmunization - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Immune system disorders
Alopecia - Grade 1
|
21.2%
7/33 • Number of events 7 • Adverse events were recorded for 100 days following transplant.
|
11.1%
5/45 • Number of events 5 • Adverse events were recorded for 100 days following transplant.
|
|
Immune system disorders
Alopecia - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Psychiatric disorders
Altered Mental State - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Altered Taste - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Reproductive system and breast disorders
Aspiration - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Asthenia - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma - Grade 2
|
9.1%
3/33 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Atrial Fibrillation - Grade 2
|
9.1%
3/33 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
8.9%
4/45 • Number of events 6 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Atrial tachycardia - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Awakening to Urinate - Grade 1
|
21.2%
7/33 • Number of events 7 • Adverse events were recorded for 100 days following transplant.
|
20.0%
9/45 • Number of events 9 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
Bacteremia - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
Bacteremia - Grade 3
|
12.1%
4/33 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
11.1%
5/45 • Number of events 5 • Adverse events were recorded for 100 days following transplant.
|
|
Nervous system disorders
Balance Problems - Grade 1
|
9.1%
3/33 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Barodontalgia - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Psychiatric disorders
Behavioral Issues - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
BK Viremia - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
BK Viremia - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
BK Viremia - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
BK Virus Cystitis - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Bleeding - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Blister - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Bloating - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Bloating - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Eye disorders
Blurred Vision - Grade 1
|
12.1%
4/33 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
15.6%
7/45 • Number of events 8 • Adverse events were recorded for 100 days following transplant.
|
|
Eye disorders
Blurred Vision - Grade 2
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Bradycardia - Grade 1
|
12.1%
4/33 • Number of events 5 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Bradycardia - Grade 2
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis - Grade 1
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Bruising - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Ear and labyrinth disorders
Burning Ears - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Burning Palms - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
Candidemia - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Cardiac - Abnormal T wave - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Celiac artery stenosis - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
Cellulitis - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Psychiatric disorders
Change in Mental Status - Grade 2
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Eye disorders
Change in Vision - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Musculoskeletal and connective tissue disorders
Charcot Foot - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Musculoskeletal and connective tissue disorders
Charcot Joint - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Chipped tooth - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Cholelithiasis - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Chronic Kidney Disease - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
DVT - Pericatheter Thrombus - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Dysgeusia - Grade 1
|
9.1%
3/33 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
11.1%
5/45 • Number of events 5 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Dysgeusia - Grade 2
|
9.1%
3/33 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Dyspepsia - Grade 1
|
3.0%
1/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Dyspepsia - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Dysphagia - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Dysphagia - Grade 2
|
9.1%
3/33 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea - Grade 1
|
24.2%
8/33 • Number of events 11 • Adverse events were recorded for 100 days following transplant.
|
28.9%
13/45 • Number of events 16 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea - Grade 2
|
21.2%
7/33 • Number of events 7 • Adverse events were recorded for 100 days following transplant.
|
15.6%
7/45 • Number of events 7 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea on Exertion - Grade 1
|
12.1%
4/33 • Number of events 5 • Adverse events were recorded for 100 days following transplant.
|
8.9%
4/45 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea on Exertion - Grade 2
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
13.3%
6/45 • Number of events 6 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Dysuria - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Dysuria - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
15.6%
7/45 • Number of events 7 • Adverse events were recorded for 100 days following transplant.
|
|
Ear and labyrinth disorders
Ear Fullness - grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Ear and labyrinth disorders
Ear Wax - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Eczema - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Edema - Grade 1
|
18.2%
6/33 • Number of events 6 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Edema - Grade 2
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Edema - Ankle - Grade 1
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Edema - Arm - Grade 1
|
6.1%
2/33 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Edema - Arytenoid - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Edema - Elbow - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Edema - Extremities - Grade 1
|
18.2%
6/33 • Number of events 7 • Adverse events were recorded for 100 days following transplant.
|
51.1%
23/45 • Number of events 23 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Edema - Extremities - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
8.9%
4/45 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Edema - Eye - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Edema - Eye Lid - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Edema - Face - Grade 1
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Edema - Foot - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Edema - Genital - Grade 2
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Edema - Groin - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Edema - Hand - Grade 1
|
9.1%
3/33 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Edema - Jaw - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Edema - Knees - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Edema - Neck - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Edema - Neck - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Edema - Periorbial - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Ejection Fraction Decreased - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Blood and lymphatic system disorders
Electrolyte Imbalance - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Blood and lymphatic system disorders
Electrolyte Imbalance - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Blood and lymphatic system disorders
Electrolyte Imbalance - Grade 3
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
15.6%
7/45 • Number of events 7 • Adverse events were recorded for 100 days following transplant.
|
|
Blood and lymphatic system disorders
Elevated alkaline phosphatase - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Hepatobiliary disorders
Elevated ferritin - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Hepatobiliary disorders
Elevated ferritin - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Aphthous ulcer - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Arrhythmia - Grade 1
|
9.1%
3/33 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Arrhythmia - Grade 2
|
9.1%
3/33 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Musculoskeletal and connective tissue disorders
Arthraglia - Grade 1
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
22.2%
10/45 • Number of events 10 • Adverse events were recorded for 100 days following transplant.
|
|
Musculoskeletal and connective tissue disorders
Arthraglia - Grade 2
|
27.3%
9/33 • Number of events 9 • Adverse events were recorded for 100 days following transplant.
|
20.0%
9/45 • Number of events 9 • Adverse events were recorded for 100 days following transplant.
|
|
Musculoskeletal and connective tissue disorders
Arthraglia - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Ascites - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Ascites - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
Aseptic Meningitis - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Hepatobiliary disorders
Aspartate aminotransferase increased - Grade 1
|
9.1%
3/33 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
13.3%
6/45 • Number of events 6 • Adverse events were recorded for 100 days following transplant.
|
|
Blood and lymphatic system disorders
Fluid Overload - Grade 2
|
24.2%
8/33 • Number of events 8 • Adverse events were recorded for 100 days following transplant.
|
17.8%
8/45 • Number of events 9 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Flushing - Grade 1
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Folliculitis - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Foot Redness - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Musculoskeletal and connective tissue disorders
Fracture - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
Fungal Rash - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Musculoskeletal and connective tissue disorders
Gait disturbance - Grade 1
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
Musculoskeletal and connective tissue disorders
Gait disturbance - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Gastritis - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
gastroesophageal reflux disease - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
gastroesophageal reflux disease - Grade 2
|
21.2%
7/33 • Number of events 7 • Adverse events were recorded for 100 days following transplant.
|
24.4%
11/45 • Number of events 11 • Adverse events were recorded for 100 days following transplant.
|
|
Hepatobiliary disorders
Gilbert's Syndrome - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Glass opacity in the lung - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Hepatobiliary disorders
Gout - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Psychiatric disorders
Hallucinations - Grade 1
|
9.1%
3/33 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
Psychiatric disorders
Hallucinations - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Headache - Grade 1
|
24.2%
8/33 • Number of events 10 • Adverse events were recorded for 100 days following transplant.
|
17.8%
8/45 • Number of events 11 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Headache - Grade 2
|
24.2%
8/33 • Number of events 9 • Adverse events were recorded for 100 days following transplant.
|
24.4%
11/45 • Number of events 11 • Adverse events were recorded for 100 days following transplant.
|
|
Ear and labyrinth disorders
Hearing Problems - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
Ear and labyrinth disorders
Hearing Problems - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Heart Failure - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Hematochezia - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Hematoma - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Hematoma - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Blood and lymphatic system disorders
Hematuria - Grade 1
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
15.6%
7/45 • Number of events 8 • Adverse events were recorded for 100 days following transplant.
|
|
Blood and lymphatic system disorders
Hematuria - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
15.6%
7/45 • Number of events 7 • Adverse events were recorded for 100 days following transplant.
|
|
Blood and lymphatic system disorders
Hemochromatosis - Grade 1
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Blood and lymphatic system disorders
Hemochromatosis - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Blood and lymphatic system disorders
Hemochromatosis - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Hemorrhage - Oral - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Hemorrhage - Oral - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Eye disorders
Hemorrhage - Right Eye - Grade 1
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Hemorrhoids - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
11.1%
5/45 • Number of events 5 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Hemorrhoids - Grade 2
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
Hepatitis B - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Musculoskeletal and connective tissue disorders
Hernia - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
HHV-6 DNAemia - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
HHV-6 Viremia - Grade 1
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
HHV-6 Viremia - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
HHV-6 Viremia - Grade 3
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Hoarseness - Grade 1
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Eye disorders
Hordeolum externum - Grade 2
|
3.0%
1/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Hot flashes - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Hepatobiliary disorders
hyperalkalinephosphatasemia - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
11.1%
5/45 • Number of events 5 • Adverse events were recorded for 100 days following transplant.
|
|
Hepatobiliary disorders
Hyperbilirubinemia - Grade 1
|
24.2%
8/33 • Number of events 9 • Adverse events were recorded for 100 days following transplant.
|
26.7%
12/45 • Number of events 13 • Adverse events were recorded for 100 days following transplant.
|
|
Hepatobiliary disorders
Hyperbilirubinemia - Grade 2
|
15.2%
5/33 • Number of events 5 • Adverse events were recorded for 100 days following transplant.
|
15.6%
7/45 • Number of events 7 • Adverse events were recorded for 100 days following transplant.
|
|
Hepatobiliary disorders
Hyperbilirubinemia - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
8.9%
4/45 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
|
Hepatobiliary disorders
Hyperbilirubinemia - Grade 4
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Metabolism and nutrition disorders
Hyperglycemia - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Hyperkalemia - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Hyperkalemia - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Hyperkalemia - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Blood and lymphatic system disorders
Hyperlipidemia - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
8.9%
4/45 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
|
Blood and lymphatic system disorders
Hyperlipidemia - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Hypernatremia - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Hypernatremia - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Hypernatremia - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Hypertension - Grade 1
|
36.4%
12/33 • Number of events 13 • Adverse events were recorded for 100 days following transplant.
|
20.0%
9/45 • Number of events 9 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Hypertension - Grade 2
|
39.4%
13/33 • Number of events 15 • Adverse events were recorded for 100 days following transplant.
|
48.9%
22/45 • Number of events 23 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
hypervolemia - grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
hypervolemia - Grade 2
|
12.1%
4/33 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
11.1%
5/45 • Number of events 5 • Adverse events were recorded for 100 days following transplant.
|
|
Nervous system disorders
hypoesthesia - right upper quadrant - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Endocrine disorders
Hypoglycemia - Grade 1
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Reproductive system and breast disorders
hypogonadism - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Blood and lymphatic system disorders
Hypokalemia - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Blood and lymphatic system disorders
Hypokalemia - Grade 3
|
15.2%
5/33 • Number of events 5 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Hypomagnesemia - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Hypomagnesemia - Grade 2
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Hypomagnesemia - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Blood and lymphatic system disorders
Hyponatremia - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Blood and lymphatic system disorders
Hyponatremia - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Blood and lymphatic system disorders
Hypophosphatemia - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Hypotension - Grade 1
|
12.1%
4/33 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
22.2%
10/45 • Number of events 11 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Hypotension - Grade 2
|
42.4%
14/33 • Number of events 17 • Adverse events were recorded for 100 days following transplant.
|
46.7%
21/45 • Number of events 30 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Hypotension - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Hypothermia - Grade 2
|
6.1%
2/33 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
Blood and lymphatic system disorders
Hypothyroidism - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia - Grade 2
|
15.2%
5/33 • Number of events 6 • Adverse events were recorded for 100 days following transplant.
|
17.8%
8/45 • Number of events 9 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia - Grade 3
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Metabolism and nutrition disorders
Impaired fasting glucose - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Psychiatric disorders
Impulsivity - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Increased Acute Rheumatic Fever - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Hepatobiliary disorders
Increased Alkaline Phosphatase - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Increased Creatinine - Grade 1
|
18.2%
6/33 • Number of events 6 • Adverse events were recorded for 100 days following transplant.
|
13.3%
6/45 • Number of events 8 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Increased Creatinine - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Blood and lymphatic system disorders
Increased Ferritin - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Hepatobiliary disorders
Increased Liver Function Tests - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Hepatobiliary disorders
Increased Liver Function Tests - Grade 2
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Increased Urination - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Indigestion - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Indigestion - Grade 2
|
9.1%
3/33 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
8.9%
4/45 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
Infection and Infestations - Other - Grade 3
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
Infectious Diarrhea - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Laceration - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Lack of Taste - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Left ventricular dysfunction - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Musculoskeletal and connective tissue disorders
Leg Cramps - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Lesion - Rectum - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Lesion - Penis - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Lethargy - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Lethargy - Grade 2
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Lethargy - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Lipoma - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Hepatobiliary disorders
Liver Cyst - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Immune system disorders
Lung Infection - Grade 2
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Lung nodule - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Blood and lymphatic system disorders
Lymphocytosis - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Malaise - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Psychiatric disorders
Memory change - Grade 1
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Reproductive system and breast disorders
Menorrhagia - Grade 2
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Metabolism and nutrition disorders
Metabolic Alkalosis - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Migraine - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Migraine - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Mitral valve disease - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Mobitz Type I - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Mole - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Nocturia - Grade 1
|
9.1%
3/33 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
8.9%
4/45 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Nocturia - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Nonspecific skin eruption - grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Obesity - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Obesity - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Obesity - Grade 4
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive Sleep Apnea - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Odynophagia - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Oliguria - Grade 1
|
12.1%
4/33 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Oliguria - Grade 2
|
33.3%
11/33 • Number of events 14 • Adverse events were recorded for 100 days following transplant.
|
28.9%
13/45 • Number of events 15 • Adverse events were recorded for 100 days following transplant.
|
|
Nervous system disorders
Orthostatic Hypotension - Grade 2
|
12.1%
4/33 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
Nervous system disorders
Orthostatic Hypotension - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
Oseomyelitis - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Hepatobiliary disorders
Elevated Liver Function Tests - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
8.9%
4/45 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
|
Hepatobiliary disorders
Elevated Liver Function Tests - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Hepatobiliary disorders
Elevated Liver Function Tests - Grade 3
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Elevated Prostate Specific Antigen - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Endocrine disorders
Elevated Thyroid Stimulating Hormone - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Emesis - Grade 1
|
24.2%
8/33 • Number of events 13 • Adverse events were recorded for 100 days following transplant.
|
31.1%
14/45 • Number of events 17 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Emesis - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
11.1%
5/45 • Number of events 5 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Enlarged prostate - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Epigastric Burning - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Eye disorders
Epiphora - Grade 1
|
12.1%
4/33 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Epistaxis - Grade 1
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
15.6%
7/45 • Number of events 8 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Epistaxis - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Epistaxis - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
Epstein-Barr virus (EBV) positive - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Musculoskeletal and connective tissue disorders
Erectile Dysfunction - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Erythema - Grade 1
|
12.1%
4/33 • Number of events 5 • Adverse events were recorded for 100 days following transplant.
|
11.1%
5/45 • Number of events 7 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Erythema - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Erythema - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Erythema Multiforme - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Erythema Multiforme - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Erythroderma - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Erythroderma - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Esophagitis - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Esophagitis - Grade 3
|
12.1%
4/33 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Excoriation - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Excoriation - Grade 2
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Eye disorders
Eye Problems - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Eye disorders
Eye ptosis - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Facial numbness - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Facial Rash - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Fall - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Fall - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
8.9%
4/45 • Number of events 5 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Fatigue - Grade 1
|
12.1%
4/33 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
8.9%
4/45 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Fatigue - Grade 2
|
54.5%
18/33 • Number of events 20 • Adverse events were recorded for 100 days following transplant.
|
60.0%
27/45 • Number of events 27 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Fatigue - Grade 3
|
27.3%
9/33 • Number of events 9 • Adverse events were recorded for 100 days following transplant.
|
28.9%
13/45 • Number of events 13 • Adverse events were recorded for 100 days following transplant.
|
|
Immune system disorders
Fever - Grade 1
|
69.7%
23/33 • Number of events 47 • Adverse events were recorded for 100 days following transplant.
|
88.9%
40/45 • Number of events 66 • Adverse events were recorded for 100 days following transplant.
|
|
Immune system disorders
Fever - Grade 2
|
51.5%
17/33 • Number of events 22 • Adverse events were recorded for 100 days following transplant.
|
20.0%
9/45 • Number of events 14 • Adverse events were recorded for 100 days following transplant.
|
|
Immune system disorders
Fever - Grade 3
|
9.1%
3/33 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
17.8%
8/45 • Number of events 12 • Adverse events were recorded for 100 days following transplant.
|
|
Blood and lymphatic system disorders
Fibrinogen decreased - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Flatulence - Grade 1
|
6.1%
2/33 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
11.1%
5/45 • Number of events 5 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Flatulence - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Eye disorders
Floaters - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Fluid Filled Blister - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Blood and lymphatic system disorders
Fluid Overload - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - PICC site - Grade 2
|
6.1%
2/33 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - rectal - Grade 1
|
9.1%
3/33 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - rectal - Grade 2
|
9.1%
3/33 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis - Grade 2
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Abdominal - Grade 1
|
24.2%
8/33 • Number of events 11 • Adverse events were recorded for 100 days following transplant.
|
26.7%
12/45 • Number of events 12 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Abdominal - Grade 2
|
36.4%
12/33 • Number of events 15 • Adverse events were recorded for 100 days following transplant.
|
33.3%
15/45 • Number of events 20 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Arm - Grade 1
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Arm - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - B/L Hips/thighs - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Back - Grade 1
|
24.2%
8/33 • Number of events 8 • Adverse events were recorded for 100 days following transplant.
|
8.9%
4/45 • Number of events 6 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Back - Grade 2
|
12.1%
4/33 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
17.8%
8/45 • Number of events 8 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Back - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - BM site - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Bone - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Bone - Grade 2
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Buttocks - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Calf - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Calf - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Catheter site - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Chest - Grade 1
|
24.2%
8/33 • Number of events 11 • Adverse events were recorded for 100 days following transplant.
|
8.9%
4/45 • Number of events 6 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Chest - Grade 2
|
12.1%
4/33 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
8.9%
4/45 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Ear - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Elbow - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Epigastric - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Epigastric - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Extremities - Grade 1
|
12.1%
4/33 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Extremities - Grade 2
|
9.1%
3/33 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Eye - Grade 1
|
9.1%
3/33 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Face - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Face - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Feet - Grade 1
|
3.0%
1/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Flank - Grade 1
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Flank - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Foley Insertion Site - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Foot - Grade 2
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Groin - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Hand - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Hand - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Heel - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Hemorrhoids - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Hip - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Hip - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Jaw - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Jaw - Grade 2
|
9.1%
3/33 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Knee - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Knee - Grade 2
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Left Upper Quadrant - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Leg - Grade 2
|
3.0%
1/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Muscle - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Muscle - Grade 2
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Neck - Grade 1
|
12.1%
4/33 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Neck - Grade 2
|
9.1%
3/33 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Neck - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Oral - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Oral - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Pelvic - Grade 1
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Penile - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Penile - Grade 2
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Penile - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - PICC site - Grade 1
|
3.0%
1/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Hemorrhage - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Pollakiuria - Grade 1
|
12.1%
4/33 • Number of events 5 • Adverse events were recorded for 100 days following transplant.
|
17.8%
8/45 • Number of events 10 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Pollakiuria - Grade 2
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Poor Urine Output - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Immune system disorders
Postnasal drip - Grade 1
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Pressure injury - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Ear and labyrinth disorders
presyncope - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 5 • Adverse events were recorded for 100 days following transplant.
|
|
Ear and labyrinth disorders
presyncope - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
8.9%
4/45 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Pruritus - Grade 1
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
22.2%
10/45 • Number of events 12 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Pruritus - Grade 2
|
12.1%
4/33 • Number of events 5 • Adverse events were recorded for 100 days following transplant.
|
11.1%
5/45 • Number of events 6 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Ptysis - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension - Grade 1
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Scrotal - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Shoulder - Grade 1
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Shoulder - Grade 2
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Shoulder - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Sinus - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Skin - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Teeth - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Throat - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Throat - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Toe - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Urinary - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Pain - Wrist - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Pallor - Grade 1
|
9.1%
3/33 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
Parainfluenza 3 - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Nervous system disorders
Paresthesia - Grade 1
|
18.2%
6/33 • Number of events 6 • Adverse events were recorded for 100 days following transplant.
|
20.0%
9/45 • Number of events 9 • Adverse events were recorded for 100 days following transplant.
|
|
Nervous system disorders
Paresthesia - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Nervous system disorders
Paresthesia - Foot - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Nervous system disorders
Paresthesia - Mouth - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Parotitis - Grade 1
|
15.2%
5/33 • Number of events 6 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Parotitis - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Musculoskeletal and connective tissue disorders
Penile spasms - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Pericardial Effusion - Grade 1
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Pericardial Effusion - Grade 2
|
12.1%
4/33 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Pericatheter Thrombus - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Periorbital Redness - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Nervous system disorders
Peripheral Motor Neuropathy - Grade 1
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Nervous system disorders
Peripheral Motor Neuropathy - Grade 2
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Perirectal Bleed - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Perirectal Irritation - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Perorbital Bruise - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Musculoskeletal and connective tissue disorders
Petechiae - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion - Grade 1
|
9.1%
3/33 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Infiltrates - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Infiltrates - Grade 4
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary nodules - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Premature Ventricular Contractions - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Psychiatric disorders
Pyschosis - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Rash - Grade 1
|
27.3%
9/33 • Number of events 10 • Adverse events were recorded for 100 days following transplant.
|
64.4%
29/45 • Number of events 31 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Rash - Grade 2
|
51.5%
17/33 • Number of events 23 • Adverse events were recorded for 100 days following transplant.
|
37.8%
17/45 • Number of events 20 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Rash - Grade 3
|
9.1%
3/33 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
8.9%
4/45 • Number of events 5 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Rectal Itching - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Rectal Mucositis - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Renal insufficiency - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Immune system disorders
Rhinorrhea - Grade 1
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Immune system disorders
Rhinorrhea - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Nervous system disorders
Rigors - Grade 1
|
33.3%
11/33 • Number of events 14 • Adverse events were recorded for 100 days following transplant.
|
31.1%
14/45 • Number of events 17 • Adverse events were recorded for 100 days following transplant.
|
|
Nervous system disorders
Rigors - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
11.1%
5/45 • Number of events 5 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
RSV B - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Sanguineous Drainage - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Scabs - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Scar - Grade 1
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Scattered skin tears - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Scrotal Irritation - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Immune system disorders
Seasonal Allergies - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Nervous system disorders
Seizure - Grade 2
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Nervous system disorders
Sensory Neuropathy - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Reproductive system and breast disorders
Sexual Problems - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Sibilant Rhonchus - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
Musculoskeletal and connective tissue disorders
Singultus - Grade 1
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
Musculoskeletal and connective tissue disorders
Singultus - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Sinus Brachycardia - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
8.9%
4/45 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Sinus Bradycardia - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Immune system disorders
Sinus Congestion - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Immune system disorders
Sinus Congestion - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Immune system disorders
Sinus Headache - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Immune system disorders
Sinus Pressure - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Sinus Tachycardia - Grade 1
|
27.3%
9/33 • Number of events 15 • Adverse events were recorded for 100 days following transplant.
|
20.0%
9/45 • Number of events 14 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
Sinusitis - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
Sinusitis - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Skin - Peeling - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Skin discoloration - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation - Grade 1
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Immune system disorders
skin induration - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
Skin infection - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Immune system disorders
Skin irritation - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Immune system disorders
Skin irritation - Scrotum - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Lump - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Immune system disorders
Skin Nodules- Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Immune system disorders
Skin Nodules - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Immune system disorders
Skin Peeling - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Immune system disorders
Skin Peeling - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Immune system disorders
Skin Rash - GVHD - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Skin tears - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Skin tightness - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Sleep Apnea - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Small Bowel Obstruction - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Immune system disorders
Sneezing - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Somnolence - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Sore Throat - Grade 1
|
9.1%
3/33 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Sore Throat - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Speech change - Grade 1
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Subconjuctival hemorrhage - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Subcutaneous emphysema - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Supraventricular tachycardia - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Sweating - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Syncope - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
Syphilis - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Tachycardia - Grade 1
|
39.4%
13/33 • Number of events 14 • Adverse events were recorded for 100 days following transplant.
|
33.3%
15/45 • Number of events 21 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Tachycardia - Grade 2
|
12.1%
4/33 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Tender Mass - RUE - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Tenderness - skin - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Thromboembolic event - Grade 2
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
Thrush - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
Thrush - Grade 2
|
9.1%
3/33 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
Endocrine disorders
Thyroid Nodule - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Hepatobiliary disorders
Transaminitis - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Nervous system disorders
Tremor - Grade 1
|
15.2%
5/33 • Number of events 5 • Adverse events were recorded for 100 days following transplant.
|
22.2%
10/45 • Number of events 11 • Adverse events were recorded for 100 days following transplant.
|
|
Nervous system disorders
Tremor - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Nervous system disorders
Tremor - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Tricuspid valve disease - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Tussis - Grade 1
|
12.1%
4/33 • Number of events 5 • Adverse events were recorded for 100 days following transplant.
|
24.4%
11/45 • Number of events 12 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Tussis - Grade 2
|
12.1%
4/33 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Unsteadiness - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
Upper Respiratory Infection - Grade 1
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
Upper Respiratory Infection - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Urethra irritation - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Urinary frequency - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Urinary Incontinence - Grade 1
|
9.1%
3/33 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Urinary Incontinence - Grade 2
|
12.1%
4/33 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
11.1%
5/45 • Number of events 5 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Urinary Retention - Grade 1
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Urinary Retention - Grade 2
|
9.1%
3/33 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
8.9%
4/45 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
Urinary Tract Infection - Grade 2
|
9.1%
3/33 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
13.3%
6/45 • Number of events 6 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
Urinary Tract Infection - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Urinary Urgency - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Urinary Urgency - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Wound - Buttocks - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Wound - Elbow - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Wound - Sacrum - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Wound Bleeding - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Wound - Skin - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Endocrine disorders
Xerostomia - Grade 1
|
27.3%
9/33 • Number of events 11 • Adverse events were recorded for 100 days following transplant.
|
11.1%
5/45 • Number of events 5 • Adverse events were recorded for 100 days following transplant.
|
|
Endocrine disorders
Xerostomia - Grade 2
|
15.2%
5/33 • Number of events 5 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Endocrine disorders
Xerostomia - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Cystitis - Grade 3
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Immune system disorders
Cytokine Release Syndrome - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Deconditioning - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Deconditioning - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Deconditioning - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Psychiatric disorders
decreased concentration - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Decreased Ejection Fraction - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Ear and labyrinth disorders
Decreased Hearing - L ear - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Ear and labyrinth disorders
Dizziness - Grade 2
|
12.1%
4/33 • Number of events 5 • Adverse events were recorded for 100 days following transplant.
|
20.0%
9/45 • Number of events 12 • Adverse events were recorded for 100 days following transplant.
|
|
Ear and labyrinth disorders
Dry Eye - Grade 1
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Eye disorders
Dry Eyes - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Decreased urine retention - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Eye disorders
Decreased Visual Focus - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Dry Lips - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
DVT - Grade 2
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Eye disorders
Itchy Eyes - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Nausea - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Nervous system disorders
Neuralgia - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Nervous system disorders
Neuropathy - Grade 1
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Dry Nasal passages - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Dry Skin - Grade 1
|
12.1%
4/33 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
8.9%
4/45 • Number of events 5 • Adverse events were recorded for 100 days following transplant.
|
|
Nervous system disorders
Neuropathy - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
11.1%
5/45 • Number of events 5 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Dry Skin - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Decreased/coarse Breath Sounds - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Dehydration - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Dehydration - Grade 2
|
15.2%
5/33 • Number of events 5 • Adverse events were recorded for 100 days following transplant.
|
15.6%
7/45 • Number of events 7 • Adverse events were recorded for 100 days following transplant.
|
|
Psychiatric disorders
Delirium - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Psychiatric disorders
Depression - Grade 1
|
24.2%
8/33 • Number of events 8 • Adverse events were recorded for 100 days following transplant.
|
17.8%
8/45 • Number of events 8 • Adverse events were recorded for 100 days following transplant.
|
|
Psychiatric disorders
Depression - Grade 2
|
21.2%
7/33 • Number of events 7 • Adverse events were recorded for 100 days following transplant.
|
22.2%
10/45 • Number of events 10 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Detrusor contraction - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Metabolism and nutrition disorders
Diabetes - Type 2 - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Diaphoresis - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Diarrhea - Grade 1
|
48.5%
16/33 • Number of events 19 • Adverse events were recorded for 100 days following transplant.
|
33.3%
15/45 • Number of events 19 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Diarrhea - Grade 2
|
27.3%
9/33 • Number of events 14 • Adverse events were recorded for 100 days following transplant.
|
40.0%
18/45 • Number of events 23 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Diarrhea - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
8.9%
4/45 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
|
Eye disorders
Diplopia - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Psychiatric disorders
Distressed - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Ear and labyrinth disorders
Dizziness - Grade 1
|
18.2%
6/33 • Number of events 8 • Adverse events were recorded for 100 days following transplant.
|
26.7%
12/45 • Number of events 15 • Adverse events were recorded for 100 days following transplant.
|
|
Eye disorders
Conjunctivitis - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Constipation - Grade 1
|
39.4%
13/33 • Number of events 16 • Adverse events were recorded for 100 days following transplant.
|
51.1%
23/45 • Number of events 39 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Constipation - Grade 2
|
6.1%
2/33 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Cough - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Musculoskeletal and connective tissue disorders
Cramping - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Cystitis - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Renal and urinary disorders
Chronic Renal Failure - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
Clostridium Difficile Infection - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
Clostridium Difficile Infection - Grade 2
|
9.1%
3/33 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
CMV Reactivation - Grade 1
|
9.1%
3/33 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
CMV Reactivation - Grade 2
|
15.2%
5/33 • Number of events 6 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
CMV Viremia - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
CMV Viremia - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Infections and infestations
CMV Viremia - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Colitis - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Psychiatric disorders
Concentration impairment - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Psychiatric disorders
Confusion - Grade 1
|
12.1%
4/33 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
17.8%
8/45 • Number of events 11 • Adverse events were recorded for 100 days following transplant.
|
|
Psychiatric disorders
Confusion - Grade 2
|
18.2%
6/33 • Number of events 6 • Adverse events were recorded for 100 days following transplant.
|
8.9%
4/45 • Number of events 5 • Adverse events were recorded for 100 days following transplant.
|
|
Immune system disorders
Congestion - Grade 1
|
21.2%
7/33 • Number of events 7 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Immune system disorders
Congestion - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Eye disorders
Conjunctival Hemorrhage - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Eye disorders
Conjunctival Hemorrhage - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion related reaction - bradycardia - Grade 4
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - Chest pain - Grade 4
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - Chills - Grade 1
|
9.1%
3/33 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - Chest tightness - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - Chills - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion related reaction - dizziness - Grade 4
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion related reaction - eye floaters - Grade 4
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion related reaction - fatigue - Grade 4
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - Fever - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - Fever - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - Flushing - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - Hives - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - Hives - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - Hives - Grade 4
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - HSCT - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - Hypotension - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - Hypotension - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - Hypotension - Grade 4
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - Itching - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - IVIG - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - Nausea - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - Nausea - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - Nausea - Grade 4
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - Numbness - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - Platelets - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - PLTs - Grade 2
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - Pruritis - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - Rash - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - Rash - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - Rigors - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - Rigors - Grade 2
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
8.9%
4/45 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - SOB - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - Tachycardia - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - Tachycardia - Grade 2
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - unspecified - Grade 1
|
9.1%
3/33 • Number of events 6 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - unspecified - Grade 2
|
12.1%
4/33 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - unspecified - Grade 3
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - Vomiting - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction - Vomiting - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Musculoskeletal and connective tissue disorders
Inguinal hernia - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Psychiatric disorders
Insomnia - Grade 1
|
60.6%
20/33 • Number of events 25 • Adverse events were recorded for 100 days following transplant.
|
37.8%
17/45 • Number of events 18 • Adverse events were recorded for 100 days following transplant.
|
|
Psychiatric disorders
Insomnia - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
22.2%
10/45 • Number of events 12 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Intracranial Hemorrhage - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Psychiatric disorders
Irritable - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Psychiatric disorders
Irritable - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Itching Throat - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Blood and lymphatic system disorders
monoclonal gammopathy of unknown significance - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Psychiatric disorders
Mood Changes - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Mouth - Thick Mucous Secretions - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Mouth Changes - Grade 2
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Mucositis - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
17.8%
8/45 • Number of events 9 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Mucositis - Grade 2
|
18.2%
6/33 • Number of events 7 • Adverse events were recorded for 100 days following transplant.
|
22.2%
10/45 • Number of events 11 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Mucositis - Grade 3
|
69.7%
23/33 • Number of events 23 • Adverse events were recorded for 100 days following transplant.
|
31.1%
14/45 • Number of events 14 • Adverse events were recorded for 100 days following transplant.
|
|
Cardiac disorders
Murmur - Grade 1
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Myalgia - Grade 1
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Myalgia - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Nails Peeling - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Immune system disorders
Nasal Congestion - Grade 1
|
12.1%
4/33 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Immune system disorders
Nasal Congestion - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Immune system disorders
Nasal Discharge - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Dryness - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Nausea - Grade 1
|
15.2%
5/33 • Number of events 5 • Adverse events were recorded for 100 days following transplant.
|
8.9%
4/45 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
|
Gastrointestinal disorders
Nausea - Grade 2
|
30.3%
10/33 • Number of events 12 • Adverse events were recorded for 100 days following transplant.
|
26.7%
12/45 • Number of events 12 • Adverse events were recorded for 100 days following transplant.
|
|
Reproductive system and breast disorders
Vaginal bleeding - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Skin and subcutaneous tissue disorders
Vaginal Itching - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Vascular disorders
Venous stasis dermatitis - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Ear and labyrinth disorders
Vertigo - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Psychiatric disorders
Visual Hallucinations - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Psychiatric disorders
Vivid Dreams - Grade 1
|
15.2%
5/33 • Number of events 5 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Psychiatric disorders
Vivid Dreams - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Weakness - Lower extremity - Grade 1
|
12.1%
4/33 • Number of events 4 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Weakness - Lower extremity - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Weakness - Right Side - Face - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Weight Loss - Grade 1
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
6.7%
3/45 • Number of events 3 • Adverse events were recorded for 100 days following transplant.
|
|
General disorders
Weight Loss - Grade 2
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
4.4%
2/45 • Number of events 2 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Wound - Grade 1
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Wound - Grade 2
|
0.00%
0/33 • Adverse events were recorded for 100 days following transplant.
|
2.2%
1/45 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
|
Injury, poisoning and procedural complications
Wound - Back - Grade 1
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded for 100 days following transplant.
|
0.00%
0/45 • Adverse events were recorded for 100 days following transplant.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place