Trial Outcomes & Findings for Nonmyeloablative Haploidentical Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Sickle Cell Disease (NCT NCT03077542)
NCT ID: NCT03077542
Last Updated: 2024-08-07
Results Overview
The percentage of sickle cell participants at 100 days post-transplant who have not rejected their grafts and who are without severe graft-versus-host disease (GVHD). Severe GVHD is defined as grade 3 or higher for acute GVHD and moderate to severe for chronic GVHD according to NIH Consensus Criteria. Stem cell graft rejection is defined as
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
57 participants
Primary outcome timeframe
100 days post transplant
Results posted on
2024-08-07
Participant Flow
Participant milestones
| Measure |
Participants With Sickle Cell Disease in Nonmyeloablative Haplo Blood Stem Cell Transplants
Participants will receive pentostatin on days -21, -17, -13, and -9 and oral cyclophosphamide from days -21 to -8. Alemtuzumab to be infused on days -7 to -3, followed by 400 cGy TBI on day -1. Donor derived peripheral blood stem cells will given on Day 0 then Cyclophosphamide will be given at 50 mg/kg on day +3. Sirolimus loading dose of 5mg PO q4h x three doses at one day after the completion of cyclophosphamide (on day +4) and continued the following day at 5mg PO q24h to maintain trough levels between 5-15 ng/ml.
|
Human Leukocyte Antigens (HLA) Haploidentical Related Stem Cell Donor
A haploidentical relative donor will receive filgrastim (G-CSF) 10 to 16 µg/kg/d subcutaneously or intravenously for up to 6 days with apheresis collections of peripheral blood hematopoietic progenitor cells (PBPC) after the 5th day (and after the 6th day if required).
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
29
|
|
Overall Study
COMPLETED
|
18
|
27
|
|
Overall Study
NOT COMPLETED
|
10
|
2
|
Reasons for withdrawal
| Measure |
Participants With Sickle Cell Disease in Nonmyeloablative Haplo Blood Stem Cell Transplants
Participants will receive pentostatin on days -21, -17, -13, and -9 and oral cyclophosphamide from days -21 to -8. Alemtuzumab to be infused on days -7 to -3, followed by 400 cGy TBI on day -1. Donor derived peripheral blood stem cells will given on Day 0 then Cyclophosphamide will be given at 50 mg/kg on day +3. Sirolimus loading dose of 5mg PO q4h x three doses at one day after the completion of cyclophosphamide (on day +4) and continued the following day at 5mg PO q24h to maintain trough levels between 5-15 ng/ml.
|
Human Leukocyte Antigens (HLA) Haploidentical Related Stem Cell Donor
A haploidentical relative donor will receive filgrastim (G-CSF) 10 to 16 µg/kg/d subcutaneously or intravenously for up to 6 days with apheresis collections of peripheral blood hematopoietic progenitor cells (PBPC) after the 5th day (and after the 6th day if required).
|
|---|---|---|
|
Overall Study
Death
|
4
|
0
|
|
Overall Study
Physician Decision
|
6
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Nonmyeloablative Haploidentical Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Sickle Cell Disease
Baseline characteristics by cohort
| Measure |
Participants With Sickle Cell Disease With Nonmyeloablative Haplo Blood Stem Cell Transplants
n=28 Participants
Participants will receive pentostatin on days -21, -17, -13, and -9 and oral cyclophosphamide from days -21 to -8. Alemtuzumab to be infused on days -7 to -3, followed by 400 cGy TBI on day -1. Donor derived peripheral blood stem cells will be given on Day 0 then cyclophosphamide will be given at 50 mg/kg on day +3. Sirolimus loading dose of 5mg PO q4h x three doses at one day after the completion of cyclophosphamide (on day +4) and continued the following day at 5mg PO q24h to maintain trough levels between 5-15 ng/ml.
|
Human Leukocyte Antigens (HLA) Haploidentical Related Stem Cell Donor
n=29 Participants
A haploidentical relative donor will receive filgrastim (G-CSF) 10 to 16 µg/kg/d subcutaneously or intravenously for up to 6 days with apheresis collections of peripheral blood hematopoietic progenitor cells (PBPC) after the 5th day (and after the 6th day if required).
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
29 participants
n=7 Participants
|
57 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 100 days post transplantPopulation: Analysis includes only those participants that received stem cell transplant
The percentage of sickle cell participants at 100 days post-transplant who have not rejected their grafts and who are without severe graft-versus-host disease (GVHD). Severe GVHD is defined as grade 3 or higher for acute GVHD and moderate to severe for chronic GVHD according to NIH Consensus Criteria. Stem cell graft rejection is defined as
Outcome measures
| Measure |
Participants With Sickle Cell Disease With Nonmyeloablative Haplo Blood Stem Cell Transplants
n=22 Participants
Participants will receive pentostatin on days -21, -17, -13, and -9 and oral cyclophosphamide from days -21 to -8. Alemtuzumab to be infused on days -7 to -3, followed by 400 cGy TBI on day -1. Donor derived peripheral blood stem cells will be given on Day 0 then cyclophosphamide will be given at 50 mg/kg on day +3. Sirolimus loading dose of 5mg PO q4h x three doses at one day after the completion of cyclophosphamide (on day +4) and continued the following day at 5mg PO q24h to maintain trough levels between 5-15 ng/ml.
|
|---|---|
|
Percentage of Participants Who Have Not Rejected Their Stem Cell Graft and Who Are Without Severe Graft-versus-host Disease Following Stem Cell Transplant
|
20 Participants
|
SECONDARY outcome
Timeframe: Up to Year 5The level of chimerism required to maintain both graft survival as well as hematologic normalcy. Hematologic normalcy may be defined as: being free from acute complications of sickle cell disease. The chimeric status of patients will be measured on days +14 (or when subject starts to engraft), +30, +60 and +100, and periodically after day +100, by microsatellite analysis of the peripheral blood. Engraftment of donor cells was assessed with the use of methods that detect informative polymorphisms in regions known to contain short tandem repeats. Peripheral-blood CD3+ T cells and CD14+CD15+ myeloid cells were selected for analysis with the use of immunomagnetic beads (Dynal).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearIncidence of donor type hemoglobin at 1 year post-transplant in SCD patients who have not been transfused in the previous 3 months.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 100Number of participants who developed Acute Graft vs Host Disease (GVHD) Grades I, II, III, IV as defined by CIMBTR criteria for Organ Stages of Acute GVHD. Grades are defined as: Grade I: Skin = Maculopapular rash\< 25% of body surface area (BSA); Liver = Total Bilirubin 2-3 mg/dL; Lower GI = stool output/day is 500-999 mL/day. Grade II: Skin = rash on 25-50 percent body surface area; Liver = Total Bilirubin 3.1-6.0 mg/dL; Lower GI = Diarrhea 1001-1500 mL/day. Grade III: Skin = Rash on \>50% of body surface; Liver = Total Bilirubin 6.1 - 15.0 mg/dL; Lower GI = Diarrhea \> 1500 mL/day. Grade IV: Skin = Generalized erythroderma plus bullous formation; Liver = Total Bilirubin \>15 mg/dL; Lower GI = Severe abdominal pain with or without ileus. Grade I GVHD is characterized as mild disease, grade II GVHD as moderate, grade III as severe, and grade IV life-threatening.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Year 5Number of Participants Who Developed Moderate or Severe Chronic Graft vs Host Disease (GVHD) up to 5 years. Moderate chronic GVHD involves EITHER 3 organs/sites with no clinically significant functional impairment OR a less than or equal to 1 organ/site with clinically significant functional impairment, but no major disability. Severe GVHD is associated with a major disability caused by chronic GVHD.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Year 5Percentage of participant that are disease-free survival following stem cell transplant. Disease-free survival is defined as alive and free acute complications related to sickle cell disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Year 5Percentage of Participant Overall Survival up to year 5 following stem cell transplant. Overall survival is defined as being alive following stem cell transplant.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 YearsIncidence of graft failure following stem cell transplant. Graft failure is defined as the absence of or insufficient donor chimerism associated with the return of acute complications of sickle cell disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsParticipant graft rejection rate following stem cell transplant. Graft rejection is defined as donor myeloid chimerism and donor lymphoid chimerism \<5%.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearNumber of participants that experienced transplant-related mortality. Transplant-related mortality is defined as death that is at least possibly related to the transplant (GVHD, toxicity, infection, other causes).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Year 5Determine whether the type of haploidentical donor impacts the incidence of regimen failure. Number of participants that experienced regimen failure and type of haploidentical donor. Determine whether specific haploidentical donors (i.e. parent versus sibling versus child) will decrease the incidence of regimen failure. Haploidentical donor analyses include mother versus father, parent versus sibling, and parent versus child.
Outcome measures
Outcome data not reported
Adverse Events
Participants With Sickle Cell Disease in Nonmyeloablative Haplo Blood Stem Cell Transplants
Serious events: 25 serious events
Other events: 26 other events
Deaths: 4 deaths
Human Leukocyte Antigens (HLA) Haploidentical Related Stem Cell Donor
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Participants With Sickle Cell Disease in Nonmyeloablative Haplo Blood Stem Cell Transplants
n=28 participants at risk
Participants will receive pentostatin on days -21, -17, -13, and -9 and oral cyclophosphamide from days -21 to -8. Alemtuzumab to be infused on days -7 to -3, followed by 400 cGy TBI on day -1. Donor derived peripheral blood stem cells will given on Day 0 then Cyclophosphamide will be given at 50 mg/kg on day +3. Sirolimus loading dose of 5mg PO q4h x three doses at one day after the completion of cyclophosphamide (on day +4) and continued the following day at 5mg PO q24h to maintain trough levels between 5-15 ng/ml.
|
Human Leukocyte Antigens (HLA) Haploidentical Related Stem Cell Donor
n=29 participants at risk
A haploidentical relative donor will receive filgrastim (G-CSF) 10 to 16 µg/kg/d subcutaneously or intravenously for up to 6 days with apheresis collections of peripheral blood hematopoietic progenitor cells (PBPC) after the 5th day (and after the 6th day if required).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
21.4%
6/28 • Number of events 11 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Cardiac disorders
Atrial fibrillation
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Cardiac disorders
Rapid ventricular response
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Cardiac disorders
Heart failure
|
3.6%
1/28 • Number of events 2 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Cardiac disorders
Sinus tachycardia
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Cardiac disorders
Supraventricular tachycardia
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Gastrointestinal disorders
Abdominal pain
|
17.9%
5/28 • Number of events 7 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Gastrointestinal disorders
Colitis
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Gastrointestinal disorders
Constipation
|
7.1%
2/28 • Number of events 2 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Gastrointestinal disorders
Diarrhea
|
10.7%
3/28 • Number of events 5 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Gastrointestinal disorders
Dry mouth
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Gastrointestinal disorders
Dysphagia
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Gastrointestinal disorders
Enterocolitis
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Gastrointestinal disorders
GI Bleeding
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Gastrointestinal disorders
Gastroenteritis
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Gastrointestinal disorders
Hernia
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Gastrointestinal disorders
Melena
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Gastrointestinal disorders
Unspecified Liver Lesion
|
3.6%
1/28 • Number of events 2 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Gastrointestinal disorders
Nausea
|
10.7%
3/28 • Number of events 4 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Gastrointestinal disorders
Obstruction gastric
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Gastrointestinal disorders
Tooth infection
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
3.6%
1/28 • Number of events 2 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
1/28 • Number of events 2 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
General disorders
Edema limbs
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
General disorders
Fall
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
General disorders
Fatigue
|
7.1%
2/28 • Number of events 2 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
General disorders
Fever
|
25.0%
7/28 • Number of events 8 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
General disorders
Infusion related reaction
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
General disorders
Multi-organ failure
|
7.1%
2/28 • Number of events 2 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
General disorders
Non-cardiac chest pain
|
7.1%
2/28 • Number of events 2 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
General disorders
Pain
|
67.9%
19/28 • Number of events 97 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Hepatobiliary disorders
Hepatic failure
|
7.1%
2/28 • Number of events 2 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Immune system disorders
Allergic reaction
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Immune system disorders
Acute Graft versus Host Disease (aGVHD- GI)
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Immune system disorders
Angioedema
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Immune system disorders
Autoimmune hemolytic anemia
|
7.1%
2/28 • Number of events 2 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Immune system disorders
Evans Syndrome
|
7.1%
2/28 • Number of events 2 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Immune system disorders
Hemophagocytic Lymphohistiocytosis (HLH)
|
10.7%
3/28 • Number of events 3 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Immune system disorders
Thrombotic-microangiopathy (TMA)
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Infections and infestations
Bone infection
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Infections and infestations
Catheter related infection
|
10.7%
3/28 • Number of events 3 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Infections and infestations
Bacteremia
|
10.7%
3/28 • Number of events 3 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Infections and infestations
CMV reactivation
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Infections and infestations
COVID-19 infection
|
14.3%
4/28 • Number of events 4 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Infections and infestations
EBV positive post-transplant lymphoproliferative disease (PTLD)
|
17.9%
5/28 • Number of events 5 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Infections and infestations
Influenza
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Infections and infestations
Influenza B
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Infections and infestations
Pneumonia
|
3.6%
1/28 • Number of events 2 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Infections and infestations
RSV infection
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Infections and infestations
Retropharyngeal fluid collection, + for Staph aureus
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Infections and infestations
Septic shock
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Infections and infestations
Varicella zoster disease
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Infections and infestations
Lung infection
|
14.3%
4/28 • Number of events 8 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Infections and infestations
Sepsis
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Infections and infestations
Wound infection
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Injury, poisoning and procedural complications
Central apheresis line site bleeding
|
0.00%
0/28 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
3.4%
1/29 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
4/28 • Number of events 4 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Investigations
Aspartate aminotransferase increased
|
21.4%
6/28 • Number of events 7 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Investigations
Blood bilirubin increased
|
7.1%
2/28 • Number of events 2 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Investigations
Thrombocytopenia
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Investigations
Lymphocyte count decreased
|
3.6%
1/28 • Number of events 3 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Investigations
Neutrophil count decreased
|
28.6%
8/28 • Number of events 9 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Investigations
Platelet count decreased
|
25.0%
7/28 • Number of events 7 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Investigations
Weight loss
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Investigations
White blood cell decreased
|
7.1%
2/28 • Number of events 2 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Metabolism and nutrition disorders
Acidosis
|
7.1%
2/28 • Number of events 4 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Metabolism and nutrition disorders
Alkalosis
|
7.1%
2/28 • Number of events 2 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.6%
1/28 • Number of events 2 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.7%
3/28 • Number of events 5 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
10.7%
3/28 • Number of events 4 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Metabolism and nutrition disorders
Iron overload
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Metabolism and nutrition disorders
SIADH
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Musculoskeletal and connective tissue disorders
Avascular necrosis
|
10.7%
3/28 • Number of events 5 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
7.1%
2/28 • Number of events 2 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Nervous system disorders
Cognitive disturbance
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Nervous system disorders
Dizziness
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Nervous system disorders
Encephalopathy
|
7.1%
2/28 • Number of events 4 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Nervous system disorders
Headache
|
10.7%
3/28 • Number of events 4 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Nervous system disorders
Intracranial hemorrhage
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Nervous system disorders
Leukoencephalopathy
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Nervous system disorders
Adverse drug reaction
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Nervous system disorders
Necrotizing leukoencephalopathy
|
3.6%
1/28 • Number of events 2 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Nervous system disorders
Opioid toxicity
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.6%
1/28 • Number of events 3 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Nervous system disorders
Seizure
|
7.1%
2/28 • Number of events 2 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Nervous system disorders
Somnolence
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Nervous system disorders
Transient ischemic attacks
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Nervous system disorders
Tremor
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Psychiatric disorders
Depression
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Psychiatric disorders
Psychosis
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Renal and urinary disorders
Acute kidney injury
|
7.1%
2/28 • Number of events 5 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Renal and urinary disorders
Proteinuria
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Renal and urinary disorders
Focal segmental glomerulosclerosis (FSGS)
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Renal and urinary disorders
Nephrotic Syndrome
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Renal and urinary disorders
Nephrotic range proteinuria
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Renal and urinary disorders
Urinary retention
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Renal and urinary disorders
Urinary tract infection
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.6%
1/28 • Number of events 3 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
7.1%
2/28 • Number of events 2 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
10.7%
3/28 • Number of events 3 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Respiratory, thoracic and mediastinal disorders
Acute chest syndrome
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Respiratory, thoracic and mediastinal disorders
Cryptogenic organizing pneumonia.
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Respiratory, thoracic and mediastinal disorders
Hypopnea
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.3%
4/28 • Number of events 5 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Skin and subcutaneous tissue disorders
Acute Skin Graft vs Host Disease
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Surgical and medical procedures
Elective resection of seizure foci
|
3.6%
1/28 • Number of events 2 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Surgical and medical procedures
Hip arthroplasty
|
7.1%
2/28 • Number of events 3 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Surgical and medical procedures
Kidney biopsy
|
7.1%
2/28 • Number of events 2 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Surgical and medical procedures
Splenectomy
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Vascular disorders
Hematoma
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Vascular disorders
Hypertension
|
3.6%
1/28 • Number of events 2 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Vascular disorders
Hypotension
|
10.7%
3/28 • Number of events 4 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Vascular disorders
Thromboembolic event
|
7.1%
2/28 • Number of events 2 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Vascular disorders
Hemorrhagic shock
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Vascular disorders
Hypovolemic shock
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
Other adverse events
| Measure |
Participants With Sickle Cell Disease in Nonmyeloablative Haplo Blood Stem Cell Transplants
n=28 participants at risk
Participants will receive pentostatin on days -21, -17, -13, and -9 and oral cyclophosphamide from days -21 to -8. Alemtuzumab to be infused on days -7 to -3, followed by 400 cGy TBI on day -1. Donor derived peripheral blood stem cells will given on Day 0 then Cyclophosphamide will be given at 50 mg/kg on day +3. Sirolimus loading dose of 5mg PO q4h x three doses at one day after the completion of cyclophosphamide (on day +4) and continued the following day at 5mg PO q24h to maintain trough levels between 5-15 ng/ml.
|
Human Leukocyte Antigens (HLA) Haploidentical Related Stem Cell Donor
n=29 participants at risk
A haploidentical relative donor will receive filgrastim (G-CSF) 10 to 16 µg/kg/d subcutaneously or intravenously for up to 6 days with apheresis collections of peripheral blood hematopoietic progenitor cells (PBPC) after the 5th day (and after the 6th day if required).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
32.1%
9/28 • Number of events 19 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Blood and lymphatic system disorders
Engraftment Syndrome
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
35.7%
10/28 • Number of events 12 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
7.1%
2/28 • Number of events 3 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Cardiac disorders
Sinus tachycardia
|
7.1%
2/28 • Number of events 2 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
4/28 • Number of events 5 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Gastrointestinal disorders
Colitis
|
7.1%
2/28 • Number of events 2 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Gastrointestinal disorders
Gastritis
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Gastrointestinal disorders
Hematochezia
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Gastrointestinal disorders
Mucositis oral
|
7.1%
2/28 • Number of events 2 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
General disorders
Edema limbs
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
General disorders
Localized edema
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
General disorders
Pain
|
64.3%
18/28 • Number of events 33 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Immune system disorders
Suspected angioedema
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Immune system disorders
Vitiligo
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Infections and infestations
Bone infection
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Infections and infestations
Catheter related infection
|
10.7%
3/28 • Number of events 3 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Infections and infestations
Esophageal infection
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Infections and infestations
Bacteremia
|
17.9%
5/28 • Number of events 7 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Infections and infestations
CMV reactivation
|
25.0%
7/28 • Number of events 10 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Infections and infestations
Cellulitis
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Infections and infestations
Cystitis
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Infections and infestations
Folliculitis/Furuncle
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Infections and infestations
Methicillin-susceptible Staphylococcus aureus (MSSA).
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Infections and infestations
Parotitis
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Infections and infestations
Lung infection
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Infections and infestations
Soft tissue infection
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
7.1%
2/28 • Number of events 3 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Investigations
Alanine aminotransferase increased
|
21.4%
6/28 • Number of events 7 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Investigations
Aspartate aminotransferase increased
|
28.6%
8/28 • Number of events 11 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Investigations
Blood bilirubin increased
|
28.6%
8/28 • Number of events 12 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Investigations
Febrile neutropenia
|
3.6%
1/28 • Number of events 2 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Investigations
Hyperkalemia
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Investigations
Hypernatremia
|
3.6%
1/28 • Number of events 3 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Investigations
Hyponatremia
|
7.1%
2/28 • Number of events 2 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Investigations
Ferritin increased
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Investigations
Lymphocyte count decreased
|
57.1%
16/28 • Number of events 57 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Investigations
Neutrophil count decreased
|
57.1%
16/28 • Number of events 61 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
6.9%
2/29 • Number of events 2 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Investigations
Platelet count decreased
|
39.3%
11/28 • Number of events 31 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Investigations
Weight loss
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Investigations
White blood cell decreased
|
42.9%
12/28 • Number of events 44 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Metabolism and nutrition disorders
Alkalosis
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.7%
3/28 • Number of events 6 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
7.1%
2/28 • Number of events 2 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.3%
4/28 • Number of events 11 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
10.7%
3/28 • Number of events 5 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Musculoskeletal and connective tissue disorders
Skin infection
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Nervous system disorders
Encephalopathy
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Nervous system disorders
Headache
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Nervous system disorders
Serotonin syndrome
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Nervous system disorders
Seizure
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Nervous system disorders
Somnolence
|
7.1%
2/28 • Number of events 2 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Psychiatric disorders
Agitation
|
7.1%
2/28 • Number of events 2 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Psychiatric disorders
Confusion
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Renal and urinary disorders
Acute kidney injury
|
14.3%
4/28 • Number of events 7 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Skin and subcutaneous tissue disorders
Eczematous dermatitis
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Surgical and medical procedures
Abscess aspiration
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Surgical and medical procedures
Splenectomy
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Surgical and medical procedures
Tooth extraction
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Vascular disorders
Hypertension
|
7.1%
2/28 • Number of events 2 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
|
Vascular disorders
Thromboembolic event
|
3.6%
1/28 • Number of events 1 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
0.00%
0/29 • Up to 5 years
Adverse events will be collected from time of autologous stem cell collection/bone marrow harvest until completion of follow-up care post stem cell transplant. All AEs will be followed until satisfactory resolution.
|
Additional Information
Courtney Fitzhugh, M.D.
National Heart, Lung, and Blood Institute at National Institutes of Health
Phone: 301.402.6496
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place