Trial Outcomes & Findings for Melphalan+Bortezomib as a Conditioning Regimen for Autologous and Allogeneic Stem Cell Transplants in Multiple Myeloma (NCT NCT00948922)
NCT ID: NCT00948922
Last Updated: 2019-09-18
Results Overview
PFS: Number of participants, per treatment arm with progression free survival at time of analysis. Survival time will be measured from the date of transplant to the date of progression, death or the last follow-up, whichever comes first. Progressive Disease (PD): Increase of ≥ 25% from lowest response value in any one or more of the following: Serum M-component and/or; Urine M-component and/or; Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be \> 10 mg/dL; Bone marrow plasma cell percentage; absolute percentage ≥ 10%; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia that can be attributed solely to the plasma cell proliferative disorder.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
124 participants
Primary outcome timeframe
End of 2 year, post transplant follow-up
Results posted on
2019-09-18
Participant Flow
Participants were enrolled at Moffitt Cancer Center August 2009 through April 2015.
Participant milestones
| Measure |
A: Allogeneic Stem Cell Transplant
Allogeneic Stem Cell Transplant: Fludarabine+Melphalan+Bortezomib followed by Allogeneic Rescue.
Bortezomib: AUTOLOGOUS ARM: Day -3 bortezomib (1.3 mg/m\^2) as an intravenous push over 3 to 5 seconds (follows Melphalan infusion). ALLOGENEIC ARM: Day -3 bortezomib (1.3 mg/m\^2) as an intravenous push over 3 to 5 seconds (follows fludarabine and melphalan infusion).
Melphalan: AUTOLOGOUS ARM: Day -4 and Day -3 Melphalan 100 mg/m\^2/day IV over 30 minutes. ALLOGENEIC ARM: Day -4, Day -3 Melphalan 70 mg/m\^2/day IV over 30 minutes.
Fludarabine: Days -6,-5,-4,-3 Fludarabine 30 mg/m\^2/day IV
Allogeneic Stem Cell Transplant: Allogeneic Peripheral Blood Stem Cell Rescue. Day 0 Infusion of allogeneic peripheral blood stem cells. For the allogeneic matched-related donors peripheral blood stem cells will be harvested with granulocyte colony-stimulating factor (GCSF) mobilization and infused fresh to recipients. Allogeneic donor stem cells may be cryopreserved if they cannot be infused
|
B: Autologous Stem Cell Transplant
Autologous Stem Cell Transplant: Melphalan+Bortezomib followed by Autologous Rescue.
Bortezomib: AUTOLOGOUS ARM: Day -3 bortezomib (1.3 mg/m\^2) as an intravenous push over 3 to 5 seconds (follows Melphalan infusion). ALLOGENEIC ARM: Day -3 bortezomib (1.3 mg/m\^2) as an intravenous push over 3 to 5 seconds (follows fludarabine and melphalan infusion).
Melphalan: AUTOLOGOUS ARM: Day -4 and Day -3 Melphalan 100 mg/m\^2/day IV over 30 minutes. ALLOGENEIC ARM: Day -4, Day -3 Melphalan 70 mg/m\^2/day IV over 30 minutes.
Autologous Stem Cell Transplant: Autologous Stem Cell Transplant: Autologous Peripheral Blood Stem Cell Rescue. Stem cell mobilization with granulocyte colony-stimulating factor (G-CSF) at a dose of 10 μg/kg/day as per institutional standards. CD34+ peripheral blood stem cells will be collected following the administration of G-CSF as per institutional standards. Day 0 Infusion of autologous stem cells.
|
BE: Group B Expansion
Group B Expansion on Bortezomib Maintenance: Autologous Only.
Bortezomib: AUTOLOGOUS ARM: Day -3 bortezomib (1.3 mg/m\^2) as an intravenous push over 3 to 5 seconds (follows Melphalan infusion). ALLOGENEIC ARM: Day -3 bortezomib (1.3 mg/m\^2) as an intravenous push over 3 to 5 seconds (follows fludarabine and melphalan infusion).
Melphalan: AUTOLOGOUS ARM: Day -4 and Day -3 Melphalan 100 mg/m\^2/day IV over 30 minutes. ALLOGENEIC ARM: Day -4, Day -3 Melphalan 70 mg/m\^2/day IV over 30 minutes.
Autologous Stem Cell Transplant: Autologous Stem Cell Transplant: Autologous Peripheral Blood Stem Cell Rescue. Stem cell mobilization with granulocyte colony-stimulating factor (G-CSF) at a dose of 10 μg/kg/day as per institutional standards. CD34+ peripheral blood stem cells will be collected following the administration of G-CSF as per institutional standards. Day 0 Infusion of autologous stem cells.
|
|---|---|---|---|
|
Overall Study
STARTED
|
34
|
51
|
39
|
|
Overall Study
COMPLETED
|
26
|
37
|
38
|
|
Overall Study
NOT COMPLETED
|
8
|
14
|
1
|
Reasons for withdrawal
| Measure |
A: Allogeneic Stem Cell Transplant
Allogeneic Stem Cell Transplant: Fludarabine+Melphalan+Bortezomib followed by Allogeneic Rescue.
Bortezomib: AUTOLOGOUS ARM: Day -3 bortezomib (1.3 mg/m\^2) as an intravenous push over 3 to 5 seconds (follows Melphalan infusion). ALLOGENEIC ARM: Day -3 bortezomib (1.3 mg/m\^2) as an intravenous push over 3 to 5 seconds (follows fludarabine and melphalan infusion).
Melphalan: AUTOLOGOUS ARM: Day -4 and Day -3 Melphalan 100 mg/m\^2/day IV over 30 minutes. ALLOGENEIC ARM: Day -4, Day -3 Melphalan 70 mg/m\^2/day IV over 30 minutes.
Fludarabine: Days -6,-5,-4,-3 Fludarabine 30 mg/m\^2/day IV
Allogeneic Stem Cell Transplant: Allogeneic Peripheral Blood Stem Cell Rescue. Day 0 Infusion of allogeneic peripheral blood stem cells. For the allogeneic matched-related donors peripheral blood stem cells will be harvested with granulocyte colony-stimulating factor (GCSF) mobilization and infused fresh to recipients. Allogeneic donor stem cells may be cryopreserved if they cannot be infused
|
B: Autologous Stem Cell Transplant
Autologous Stem Cell Transplant: Melphalan+Bortezomib followed by Autologous Rescue.
Bortezomib: AUTOLOGOUS ARM: Day -3 bortezomib (1.3 mg/m\^2) as an intravenous push over 3 to 5 seconds (follows Melphalan infusion). ALLOGENEIC ARM: Day -3 bortezomib (1.3 mg/m\^2) as an intravenous push over 3 to 5 seconds (follows fludarabine and melphalan infusion).
Melphalan: AUTOLOGOUS ARM: Day -4 and Day -3 Melphalan 100 mg/m\^2/day IV over 30 minutes. ALLOGENEIC ARM: Day -4, Day -3 Melphalan 70 mg/m\^2/day IV over 30 minutes.
Autologous Stem Cell Transplant: Autologous Stem Cell Transplant: Autologous Peripheral Blood Stem Cell Rescue. Stem cell mobilization with granulocyte colony-stimulating factor (G-CSF) at a dose of 10 μg/kg/day as per institutional standards. CD34+ peripheral blood stem cells will be collected following the administration of G-CSF as per institutional standards. Day 0 Infusion of autologous stem cells.
|
BE: Group B Expansion
Group B Expansion on Bortezomib Maintenance: Autologous Only.
Bortezomib: AUTOLOGOUS ARM: Day -3 bortezomib (1.3 mg/m\^2) as an intravenous push over 3 to 5 seconds (follows Melphalan infusion). ALLOGENEIC ARM: Day -3 bortezomib (1.3 mg/m\^2) as an intravenous push over 3 to 5 seconds (follows fludarabine and melphalan infusion).
Melphalan: AUTOLOGOUS ARM: Day -4 and Day -3 Melphalan 100 mg/m\^2/day IV over 30 minutes. ALLOGENEIC ARM: Day -4, Day -3 Melphalan 70 mg/m\^2/day IV over 30 minutes.
Autologous Stem Cell Transplant: Autologous Stem Cell Transplant: Autologous Peripheral Blood Stem Cell Rescue. Stem cell mobilization with granulocyte colony-stimulating factor (G-CSF) at a dose of 10 μg/kg/day as per institutional standards. CD34+ peripheral blood stem cells will be collected following the administration of G-CSF as per institutional standards. Day 0 Infusion of autologous stem cells.
|
|---|---|---|---|
|
Overall Study
Did not start study treatment
|
2
|
5
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
1
|
|
Overall Study
Death
|
3
|
0
|
0
|
|
Overall Study
Disease progression
|
0
|
1
|
0
|
|
Overall Study
Insurance issues
|
1
|
0
|
0
|
|
Overall Study
Transplant eligibility issues
|
2
|
3
|
0
|
|
Overall Study
Not evaluable at time of analysis
|
0
|
3
|
0
|
Baseline Characteristics
Melphalan+Bortezomib as a Conditioning Regimen for Autologous and Allogeneic Stem Cell Transplants in Multiple Myeloma
Baseline characteristics by cohort
| Measure |
A: Allogeneic Stem Cell Transplant
n=34 Participants
Allogeneic Stem Cell Transplant: Fludarabine+Melphalan+Bortezomib followed by Allogeneic Rescue.
|
B: Autologous Stem Cell Transplant
n=51 Participants
Autologous Stem Cell Transplant: Melphalan+Bortezomib followed by Autologous Rescue.
|
BE: Group B Expansion
n=39 Participants
Group B Expansion on Bortezomib Maintenance: Autologous Only.
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.5 years
n=99 Participants
|
62 years
n=107 Participants
|
62 years
n=206 Participants
|
60 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
62 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
62 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
104 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
102 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=99 Participants
|
51 participants
n=107 Participants
|
39 participants
n=206 Participants
|
124 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: End of 2 year, post transplant follow-upPopulation: All participants evaluable at time of analysis
PFS: Number of participants, per treatment arm with progression free survival at time of analysis. Survival time will be measured from the date of transplant to the date of progression, death or the last follow-up, whichever comes first. Progressive Disease (PD): Increase of ≥ 25% from lowest response value in any one or more of the following: Serum M-component and/or; Urine M-component and/or; Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be \> 10 mg/dL; Bone marrow plasma cell percentage; absolute percentage ≥ 10%; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia that can be attributed solely to the plasma cell proliferative disorder.
Outcome measures
| Measure |
A: Allogeneic Stem Cell Transplant
n=26 Participants
Allogeneic Stem Cell Transplant: Fludarabine+Melphalan+Bortezomib followed by Allogeneic Rescue.
|
B: Autologous Stem Cell Transplant
n=37 Participants
Autologous Stem Cell Transplant: Melphalan+Bortezomib followed by Autologous Rescue.
|
BE: Group B Expansion
n=38 Participants
Group B Expansion on Bortezomib Maintenance: Autologous Only.
|
|---|---|---|---|
|
Progression Free Survival (PFS)
|
17 Participants
|
25 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: End of 2 year, post transplant follow-upOverall survival in participants with multiple myeloma treated with Bortezomib (Velcade®) containing conditioning regimen and autologous as well as allogeneic transplantation.
Outcome measures
| Measure |
A: Allogeneic Stem Cell Transplant
n=26 Participants
Allogeneic Stem Cell Transplant: Fludarabine+Melphalan+Bortezomib followed by Allogeneic Rescue.
|
B: Autologous Stem Cell Transplant
n=37 Participants
Autologous Stem Cell Transplant: Melphalan+Bortezomib followed by Autologous Rescue.
|
BE: Group B Expansion
n=38 Participants
Group B Expansion on Bortezomib Maintenance: Autologous Only.
|
|---|---|---|---|
|
Overall Survival (OS) Rate
|
79.2 percentage
Interval 57.0 to 90.8
|
89.2 percentage
Interval 73.7 to 95.8
|
97.3 percentage
Interval 82.3 to 99.6
|
SECONDARY outcome
Timeframe: End of 2 year, post transplant follow-upPopulation: Patients were in very good partial response at the time on enrollment without sufficient plasma cells in bone marrow to be able to perform assay for molecular response.
Complete Response according to International Myeloma Working Group uniform response criteria. CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: End of 2 year, post transplant follow-upPopulation: Allogenic Stem Cell Transplant patients only. Autologous patients do not suffer from GVHD.
Percentage of participants with Acute or Chronic GVHD following transplant
Outcome measures
| Measure |
A: Allogeneic Stem Cell Transplant
n=26 Participants
Allogeneic Stem Cell Transplant: Fludarabine+Melphalan+Bortezomib followed by Allogeneic Rescue.
|
B: Autologous Stem Cell Transplant
Autologous Stem Cell Transplant: Melphalan+Bortezomib followed by Autologous Rescue.
|
BE: Group B Expansion
Group B Expansion on Bortezomib Maintenance: Autologous Only.
|
|---|---|---|---|
|
Percentage of Participants With Acute or Chronic Graft-versus-host Disease (GVHD) Following Transplant
|
34 percentage of participants
|
—
|
—
|
Adverse Events
A: Allogeneic Stem Cell Transplant
Serious events: 13 serious events
Other events: 0 other events
Deaths: 3 deaths
B: Autologous Stem Cell Transplant
Serious events: 18 serious events
Other events: 1 other events
Deaths: 1 deaths
BE: Group B Expansion
Serious events: 10 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
A: Allogeneic Stem Cell Transplant
n=32 participants at risk
Allogeneic Stem Cell Transplant: Fludarabine+Melphalan+Bortezomib followed by Allogeneic Rescue.
|
B: Autologous Stem Cell Transplant
n=42 participants at risk
Autologous Stem Cell Transplant: Melphalan+Bortezomib followed by Autologous Rescue.
|
BE: Group B Expansion
n=39 participants at risk
Group B Expansion on Bortezomib Maintenance: Autologous Only.
|
|---|---|---|---|
|
Immune system disorders
Allergic reaction
|
0.00%
0/32 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.4%
1/42 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other
|
3.1%
1/32 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/42 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Blood and lymphatic system disorders
Haptoglobin
|
0.00%
0/32 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.4%
1/42 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/32 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.4%
1/42 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
0.00%
0/32 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/42 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
5.1%
2/39 • Number of events 2 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia - Atrial fibrillation
|
0.00%
0/32 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
7.1%
3/42 • Number of events 3 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Cardiac disorders
Cardiac General - Other
|
3.1%
1/32 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/42 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Cardiac disorders
Cardiopulmonary arrest, cause unknown (non-fatal)
|
0.00%
0/32 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/42 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.6%
1/39 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Cardiac disorders
Hypotension
|
3.1%
1/32 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.4%
1/42 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
General disorders
Fatigue
|
0.00%
0/32 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.4%
1/42 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
General disorders
Fever (in the absence of neutropenia)
|
9.4%
3/32 • Number of events 3 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/42 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
General disorders
Death not associated with CTCAE term
|
9.4%
3/32 • Number of events 3 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.4%
1/42 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/32 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/42 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.6%
1/39 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/32 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/42 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.6%
1/39 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Gastrointestinal disorders
Dysphagia
|
3.1%
1/32 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/42 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Gastrointestinal disorders
Esophagitis
|
3.1%
1/32 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/42 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
3.1%
1/32 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.4%
1/42 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Gastrointestinal disorders
Mucositis/stomatitis
|
3.1%
1/32 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/42 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Gastrointestinal disorders
Nausea
|
3.1%
1/32 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
4.8%
2/42 • Number of events 2 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
5.1%
2/39 • Number of events 2 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Gastrointestinal disorders
Typhlitis
|
0.00%
0/32 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/42 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.6%
1/39 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/32 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.4%
1/42 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.6%
1/39 • Number of events 2 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Musculoskeletal and connective tissue disorders
Hemorrhage/Bleeding - Other, knee effusion
|
0.00%
0/32 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.4%
1/42 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Infections and infestations
Colitis, infectious
|
0.00%
0/32 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.4%
1/42 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.6%
1/39 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Infections and infestations
Febrile neutropenia
|
3.1%
1/32 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.4%
1/42 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Brain
|
3.1%
1/32 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/42 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Lung
|
0.00%
0/32 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.4%
1/42 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Paranasal
|
3.1%
1/32 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/42 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Salivary gland
|
3.1%
1/32 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/42 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Skin
|
0.00%
0/32 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/42 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.6%
1/39 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Infections and infestations
Infection with unknown ANC - Appendix
|
0.00%
0/32 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.4%
1/42 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Infections and infestations
Infection with unknown ANC - Gallbladder
|
0.00%
0/32 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.4%
1/42 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Infections and infestations
Infection with unknown ANC - Salivary gland
|
3.1%
1/32 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/42 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Infections and infestations
Infection with unknown ANC - Skin
|
0.00%
0/32 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.4%
1/42 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Infections and infestations
Opportunistic infection associated with >= Grade 2 Lymphopenia
|
3.1%
1/32 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/42 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Metabolism and nutrition disorders
ALT, SGPT - Increase
|
3.1%
1/32 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.4%
1/42 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Metabolism and nutrition disorders
AST, SGOT - Increase
|
3.1%
1/32 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.4%
1/42 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
3.1%
1/32 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.4%
1/42 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Metabolism and nutrition disorders
Calcium, serum-high (hypercalcemia)
|
0.00%
0/32 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.4%
1/42 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Musculoskeletal and connective tissue disorders
Arthritis (non-septic)
|
0.00%
0/32 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.4%
1/42 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/32 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.4%
1/42 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/32 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.4%
1/42 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Nervous system disorders
Encephalopathy
|
3.1%
1/32 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/42 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Nervous system disorders
Extrapyramidal/involuntary movement/restlessness
|
0.00%
0/32 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.4%
1/42 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Psychiatric disorders
Mental status
|
0.00%
0/32 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.4%
1/42 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
3.1%
1/32 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.4%
1/42 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
0.00%
0/32 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.4%
1/42 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.2%
2/32 • Number of events 2 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.4%
1/42 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Respiratory, thoracic and mediastinal disorders
Edema, larynx
|
0.00%
0/32 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.4%
1/42 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.1%
1/32 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/42 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other, Pneumonia
|
3.1%
1/32 • Number of events 2 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/42 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other, Pulmonary edema
|
3.1%
1/32 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/42 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other, Acute respiratory failure
|
0.00%
0/32 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/42 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.6%
1/39 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Renal and urinary disorders
Renal failure
|
6.2%
2/32 • Number of events 2 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.4%
1/42 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
5.1%
2/39 • Number of events 2 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other, Renal insufficiency
|
0.00%
0/32 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.4%
1/42 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other, Hematuria
|
0.00%
0/32 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/42 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.6%
1/39 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary malignancy - possibly related to cancer treatment
|
3.1%
1/32 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/42 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Vascular disorders
Thrombosis/embolism (vascular access-related)
|
3.1%
1/32 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.4%
1/42 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
3.1%
1/32 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/42 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
Other adverse events
| Measure |
A: Allogeneic Stem Cell Transplant
n=32 participants at risk
Allogeneic Stem Cell Transplant: Fludarabine+Melphalan+Bortezomib followed by Allogeneic Rescue.
|
B: Autologous Stem Cell Transplant
n=42 participants at risk
Autologous Stem Cell Transplant: Melphalan+Bortezomib followed by Autologous Rescue.
|
BE: Group B Expansion
n=39 participants at risk
Group B Expansion on Bortezomib Maintenance: Autologous Only.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/32 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
2.4%
1/42 • Number of events 1 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
0.00%
0/39 • 7 years, 8 months
All Serious Adverse Events are reported, regardless of causality. For this study that includes patients undergoing hematopoietic cell transplantation (HCT), review and consideration was given for reporting of Other Adverse Events that are designated in the protocol as commonly observed after HCT. Patients are monitored for Serious Adverse Events and Other Adverse events beginning at on treatment date. Patients who did not receive treatment: not included in at risk numbers.
|
Additional Information
Dr. Melissa Alsina
H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-7202
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place