Trial Outcomes & Findings for Pilot and Feasibility Study of Reduced-Intensity Hematopoietic Stem Cell Transplant for MonoMAC (NCT NCT00923364)
NCT ID: NCT00923364
Last Updated: 2020-03-12
Results Overview
Neutrophil engraftment is defined as a neutrophil count of \>0.5 x 10(9) cells/L for 3 consecutive days.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
30 days
Results posted on
2020-03-12
Participant Flow
Participant milestones
| Measure |
Recipients
Hematopoietic Stem Cell Transplant for MonoMAC: 10/10 Human Leukocyte Antigen (HLA) Matched Related Donor (MRD) or Unrelated Donor (URD) Transplant. 9/10 HLA Matched Related Donor or Unrelated Donor Transplant. Haploidentical Related Donor Transplant. Umbilical Cord Blood Transplant.
Fludarabine(Fludara,Berlex Laboratories): 40 mg/m(2) intravenous (IV) (in the vein) over 30 minutes (in the vein) once daily on Days -6, -5, -4, and -3 or 30 mg/m(2) IV over 30 minutes (in the vein) once daily on Days -6, -5, -4, -3, and -2
Total Body Irradiation (TBI): 200 centigray (cGy) on Day -1 or 300 cGy on Day -1 (for 9/10 URD and Haplo patients)
Allogeneic hematopoietic stem cell (HSC): stem cell transplant
|
Healthy Related Donors
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
5
|
|
Overall Study
COMPLETED
|
10
|
5
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
Recipients
Hematopoietic Stem Cell Transplant for MonoMAC: 10/10 Human Leukocyte Antigen (HLA) Matched Related Donor (MRD) or Unrelated Donor (URD) Transplant. 9/10 HLA Matched Related Donor or Unrelated Donor Transplant. Haploidentical Related Donor Transplant. Umbilical Cord Blood Transplant.
Fludarabine(Fludara,Berlex Laboratories): 40 mg/m(2) intravenous (IV) (in the vein) over 30 minutes (in the vein) once daily on Days -6, -5, -4, and -3 or 30 mg/m(2) IV over 30 minutes (in the vein) once daily on Days -6, -5, -4, -3, and -2
Total Body Irradiation (TBI): 200 centigray (cGy) on Day -1 or 300 cGy on Day -1 (for 9/10 URD and Haplo patients)
Allogeneic hematopoietic stem cell (HSC): stem cell transplant
|
Healthy Related Donors
|
|---|---|---|
|
Overall Study
Death
|
3
|
0
|
|
Overall Study
Did not go to transplant
|
1
|
0
|
Baseline Characteristics
Pilot and Feasibility Study of Reduced-Intensity Hematopoietic Stem Cell Transplant for MonoMAC
Baseline characteristics by cohort
| Measure |
Recipients and Healthy Related Donors
n=19 Participants
Hematopoietic Stem Cell Transplant for MonoMAC: 10/10 Human Leukocyte Antigen (HLA) Matched Related Donor (MRD) or Unrelated Donor (URD) Transplant. 9/10 HLA Matched Related Donor or Unrelated Donor Transplant. Haploidentical Related Donor Transplant. Umbilical Cord Blood Transplant.
Fludarabine(Fludara,Berlex Laboratories): 40 mg/m(2) intravenous (IV) (in the vein) over 30 minutes (in the vein) once daily on Days -6, -5, -4, and -3 or 30 mg/m(2) IV over 30 minutes (in the vein) once daily on Days -6, -5, -4, -3, and -2
Total Body Irradiation (TBI): 200 centigray (cGy) on Day -1 or 300 cGy on Day -1 (for 9/10 URD and Haplo patients)
Allogeneic hematopoietic stem cell (HSC): stem cell transplant Healthy related donors =5; recipients = 14.
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
30.21 years
STANDARD_DEVIATION 7.61 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: 10/19 analyzed:5 pts were healthy related donors, 1 pt taken off study prior to transplant \& 3 pts had early deaths (before outcome measurements could be evaluated)
Neutrophil engraftment is defined as a neutrophil count of \>0.5 x 10(9) cells/L for 3 consecutive days.
Outcome measures
| Measure |
Recipients Only
n=10 Participants
Hematopoietic Stem Cell Transplant for MonoMAC: 10/10 Human Leukocyte Antigen (HLA) Matched Related Donor (MRD) or Unrelated Donor (URD) Transplant. 9/10 HLA Matched Related Donor or Unrelated Donor Transplant. Haploidentical Related Donor Transplant. Umbilical Cord Blood Transplant.
Fludarabine(Fludara,Berlex Laboratories): 40 mg/m(2) intravenous (IV) (in the vein) over 30 minutes (in the vein) once daily on Days -6, -5, -4, and -3 or 30 mg/m(2) IV over 30 minutes (in the vein) once daily on Days -6, -5, -4, -3, and -2 Total Body Irradiation (TBI): 200 centigray (cGy) on Day -1 or 300 cGy on Day -1 (for 9/10 URD and Haplo patients) Allogeneic hematopoietic stem cell (HSC): stem cell transplant
|
|---|---|
|
Days to Neutrophil Engraftment
|
12 Days
Interval 12.0 to 80.0
|
PRIMARY outcome
Timeframe: 30 daysPopulation: 10/19 analyzed:5 pts were healthy related donors, 1 pt taken off study prior to transplant \& 3 pts had early deaths (before outcome measurements could be evaluated)
Platelet engraftment is defined as a platelet count of \>20 x 10(9) cells/L for 7 consecutive days without requiring a platelet transfusion.
Outcome measures
| Measure |
Recipients Only
n=10 Participants
Hematopoietic Stem Cell Transplant for MonoMAC: 10/10 Human Leukocyte Antigen (HLA) Matched Related Donor (MRD) or Unrelated Donor (URD) Transplant. 9/10 HLA Matched Related Donor or Unrelated Donor Transplant. Haploidentical Related Donor Transplant. Umbilical Cord Blood Transplant.
Fludarabine(Fludara,Berlex Laboratories): 40 mg/m(2) intravenous (IV) (in the vein) over 30 minutes (in the vein) once daily on Days -6, -5, -4, and -3 or 30 mg/m(2) IV over 30 minutes (in the vein) once daily on Days -6, -5, -4, -3, and -2 Total Body Irradiation (TBI): 200 centigray (cGy) on Day -1 or 300 cGy on Day -1 (for 9/10 URD and Haplo patients) Allogeneic hematopoietic stem cell (HSC): stem cell transplant
|
|---|---|
|
Days to Platelet Engraftment
|
30 Days
Interval 0.0 to 30.0
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: 10/19 analyzed:5 pts were healthy related donors, 1 pt taken off study prior to transplant \& 3 pts had early deaths (before outcome measurements could be evaluated)
Engraftment of donor cells was assessed using polymorphisms in regions known to contain short tandem repeats. Peripheral blood cluster of differentiation 14 (CD14+), cluster of differentiation 3 (CD3-)/cluster of differentiation 56 (CD56+), cluster of differentiation 19 (CD19+), and CD3+ subsets were isolated by flow cytometry and chimerism was assessed.
Outcome measures
| Measure |
Recipients Only
n=10 Participants
Hematopoietic Stem Cell Transplant for MonoMAC: 10/10 Human Leukocyte Antigen (HLA) Matched Related Donor (MRD) or Unrelated Donor (URD) Transplant. 9/10 HLA Matched Related Donor or Unrelated Donor Transplant. Haploidentical Related Donor Transplant. Umbilical Cord Blood Transplant.
Fludarabine(Fludara,Berlex Laboratories): 40 mg/m(2) intravenous (IV) (in the vein) over 30 minutes (in the vein) once daily on Days -6, -5, -4, and -3 or 30 mg/m(2) IV over 30 minutes (in the vein) once daily on Days -6, -5, -4, -3, and -2 Total Body Irradiation (TBI): 200 centigray (cGy) on Day -1 or 300 cGy on Day -1 (for 9/10 URD and Haplo patients) Allogeneic hematopoietic stem cell (HSC): stem cell transplant
|
|---|---|
|
Percentage of Donor Cells at Last Follow Up in Patients With Mutations GATA Binding Protein 2 (GATA2)
Donor CD14+ cells, %
|
99.8 percentage of donor cells
Interval 99.0 to 100.0
|
|
Percentage of Donor Cells at Last Follow Up in Patients With Mutations GATA Binding Protein 2 (GATA2)
Donor CD19+ cells, %
|
100 percentage of donor cells
Interval 100.0 to 100.0
|
|
Percentage of Donor Cells at Last Follow Up in Patients With Mutations GATA Binding Protein 2 (GATA2)
Donor CD3-/CD56+ cells, %
|
99.8 percentage of donor cells
Interval 99.0 to 100.0
|
|
Percentage of Donor Cells at Last Follow Up in Patients With Mutations GATA Binding Protein 2 (GATA2)
Donor CD3+ cells, %
|
97.6 percentage of donor cells
Interval 91.0 to 100.0
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: 10/19 analyzed:5 pts were healthy related donors, 1 pt taken off study prior to transplant \& 3 pts had early deaths (before outcome measurements could be evaluated)
Acute GVHD is assessed according to the 1994 Consensus Conference Grading Criteria. Chronic GVHD is assessed by the 2005 Chronic GVHD Consensus Project. GVHD can affect performance status and attack multiple organ systems such as the skin, liver, gut, mouth, eyes, joints, lung, etc. that can lead to a rash, diarrhea, metabolic changes, infection and/or death. The clinical grading of acute GVHD is grade 0 (none) to 4 (severe). Chronic GVHD is a delayed form of GVHD that may occur after day 100 post transplant.
Outcome measures
| Measure |
Recipients Only
n=10 Participants
Hematopoietic Stem Cell Transplant for MonoMAC: 10/10 Human Leukocyte Antigen (HLA) Matched Related Donor (MRD) or Unrelated Donor (URD) Transplant. 9/10 HLA Matched Related Donor or Unrelated Donor Transplant. Haploidentical Related Donor Transplant. Umbilical Cord Blood Transplant.
Fludarabine(Fludara,Berlex Laboratories): 40 mg/m(2) intravenous (IV) (in the vein) over 30 minutes (in the vein) once daily on Days -6, -5, -4, and -3 or 30 mg/m(2) IV over 30 minutes (in the vein) once daily on Days -6, -5, -4, -3, and -2 Total Body Irradiation (TBI): 200 centigray (cGy) on Day -1 or 300 cGy on Day -1 (for 9/10 URD and Haplo patients) Allogeneic hematopoietic stem cell (HSC): stem cell transplant
|
|---|---|
|
Incidence of Acute and Chronic Graft-versus-host Disease (GVHD)
Acute
|
2 participants
|
|
Incidence of Acute and Chronic Graft-versus-host Disease (GVHD)
Chronic
|
3 participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: 10/19 analyzed:5 pts were healthy related donors, 1 pt taken off study prior to transplant \& 3 pts had early deaths (before outcome measurements could be evaluated)
Overall survival is defined as date of on-study to date of death from any cause or last follow up.
Outcome measures
| Measure |
Recipients Only
n=10 Participants
Hematopoietic Stem Cell Transplant for MonoMAC: 10/10 Human Leukocyte Antigen (HLA) Matched Related Donor (MRD) or Unrelated Donor (URD) Transplant. 9/10 HLA Matched Related Donor or Unrelated Donor Transplant. Haploidentical Related Donor Transplant. Umbilical Cord Blood Transplant.
Fludarabine(Fludara,Berlex Laboratories): 40 mg/m(2) intravenous (IV) (in the vein) over 30 minutes (in the vein) once daily on Days -6, -5, -4, and -3 or 30 mg/m(2) IV over 30 minutes (in the vein) once daily on Days -6, -5, -4, -3, and -2 Total Body Irradiation (TBI): 200 centigray (cGy) on Day -1 or 300 cGy on Day -1 (for 9/10 URD and Haplo patients) Allogeneic hematopoietic stem cell (HSC): stem cell transplant
|
|---|---|
|
Overall Survival
|
76 months
Interval 18.0 to 95.0
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: 10/19 analyzed:5pts were healthy related donors, 1 pt taken off study prior to transplant \& 3 pts had early deaths (before outcome measurements could be evaluated)
Number of participants with documented evidence of disease progression following start of treatment.
Outcome measures
| Measure |
Recipients Only
n=10 Participants
Hematopoietic Stem Cell Transplant for MonoMAC: 10/10 Human Leukocyte Antigen (HLA) Matched Related Donor (MRD) or Unrelated Donor (URD) Transplant. 9/10 HLA Matched Related Donor or Unrelated Donor Transplant. Haploidentical Related Donor Transplant. Umbilical Cord Blood Transplant.
Fludarabine(Fludara,Berlex Laboratories): 40 mg/m(2) intravenous (IV) (in the vein) over 30 minutes (in the vein) once daily on Days -6, -5, -4, and -3 or 30 mg/m(2) IV over 30 minutes (in the vein) once daily on Days -6, -5, -4, -3, and -2 Total Body Irradiation (TBI): 200 centigray (cGy) on Day -1 or 300 cGy on Day -1 (for 9/10 URD and Haplo patients) Allogeneic hematopoietic stem cell (HSC): stem cell transplant
|
|---|---|
|
Number of Participants With Disease Free Survival
|
8 Participants
|
SECONDARY outcome
Timeframe: Date treatment consent signed to date off study, approximately, 91 monthsPopulation: Data were not collected separately for donors and recipients.
Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events v3.0. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
Recipients Only
n=19 Participants
Hematopoietic Stem Cell Transplant for MonoMAC: 10/10 Human Leukocyte Antigen (HLA) Matched Related Donor (MRD) or Unrelated Donor (URD) Transplant. 9/10 HLA Matched Related Donor or Unrelated Donor Transplant. Haploidentical Related Donor Transplant. Umbilical Cord Blood Transplant.
Fludarabine(Fludara,Berlex Laboratories): 40 mg/m(2) intravenous (IV) (in the vein) over 30 minutes (in the vein) once daily on Days -6, -5, -4, and -3 or 30 mg/m(2) IV over 30 minutes (in the vein) once daily on Days -6, -5, -4, -3, and -2 Total Body Irradiation (TBI): 200 centigray (cGy) on Day -1 or 300 cGy on Day -1 (for 9/10 URD and Haplo patients) Allogeneic hematopoietic stem cell (HSC): stem cell transplant
|
|---|---|
|
Number of Participants With Serious and Non-serious Adverse Events
|
16 Participants
|
Adverse Events
Recipients and Healthy Related Donors
Serious events: 12 serious events
Other events: 16 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Recipients and Healthy Related Donors
n=19 participants at risk
Hematopoietic Stem Cell Transplant for MonoMAC: 10/10 Human Leukocyte Antigen (HLA) Matched Related Donor (MRD) or Unrelated Donor (URD) Transplant. 9/10 HLA Matched Related Donor or Unrelated Donor Transplant. Haploidentical Related Donor Transplant. Umbilical Cord Blood Transplant.
Fludarabine(Fludara,Berlex Laboratories): 40 mg/m(2) intravenous (IV) (in the vein) over 30 minutes (in the vein) once daily on Days -6, -5, -4, and -3 or 30 mg/m(2) IV over 30 minutes (in the vein) once daily on Days -6, -5, -4, -3, and -2 Total Body Irradiation (TBI): 200 centigray (cGy) on Day -1 or 300 cGy on Day -1 (for 9/10 URD and Haplo patients) Allogeneic hematopoietic stem cell (HSC): stem cell transplant Healthy related donors =5; recipients = 14.
|
|---|---|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
10.5%
2/19 • Number of events 3 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome (ARDS)
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Cardiac disorders
Cardiac troponin I (cTnI)
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Cardiac disorders
Cardiopulmonary arrest, cause unknown (non-fatal)
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Hepatobiliary disorders
Cholecystitis
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Renal and urinary disorders
Cystitis
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Vascular disorders
DIC (disseminated intravascular coagulation)
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
General disorders
Death not associated with CTCAE term::Death NOS
|
21.1%
4/19 • Number of events 4 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Gastrointestinal disorders
Diarrhea
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
10.5%
2/19 • Number of events 2 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Infections and infestations
Febrile neutropenia
|
10.5%
2/19 • Number of events 4 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Gastrointestinal disorders
Hemorrhage, GI::Upper GI NOS
|
5.3%
1/19 • Number of events 2 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Renal and urinary disorders
Hemorrhage, GU::Vagina
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory::Lung
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Hepatobiliary disorders
Hepatobiliary/Pancreas - Other (Specify, __)
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Cardiac disorders
Hypotension
|
10.5%
2/19 • Number of events 2 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.5%
2/19 • Number of events 3 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Infections and infestations
Infection
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Infections and infestations
Infection (documented clinically or microbiologically)
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Infections and infestations
Infection - Other (Specify, __)
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Blood
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Upper aerodigestive NOS
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Infections and infestations
Infection with unknown ANC::Blood
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Infections and infestations
Infection with unknown ANC::Colon
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Nervous system disorders
Leak (including anastomotic), GI::Leak NOS
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
5.3%
1/19 • Number of events 2 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
5.3%
1/19 • Number of events 3 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
10.5%
2/19 • Number of events 2 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)::Stomach
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)::Esophagus
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)::Oral cavity
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Gastrointestinal disorders
Nausea
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Nervous system disorders
Neuropathy: motor
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Gastrointestinal disorders
Pain::Abdomen NOS
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Blood and lymphatic system disorders
Platelets
|
10.5%
2/19 • Number of events 8 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
10.5%
2/19 • Number of events 2 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
10.5%
2/19 • Number of events 3 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Metabolism and nutrition disorders
Proteinuria
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Renal and urinary disorders
Renal failure
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
10.5%
2/19 • Number of events 2 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Vascular disorders
Vessel injury-artery::Other NOS
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
Other adverse events
| Measure |
Recipients and Healthy Related Donors
n=19 participants at risk
Hematopoietic Stem Cell Transplant for MonoMAC: 10/10 Human Leukocyte Antigen (HLA) Matched Related Donor (MRD) or Unrelated Donor (URD) Transplant. 9/10 HLA Matched Related Donor or Unrelated Donor Transplant. Haploidentical Related Donor Transplant. Umbilical Cord Blood Transplant.
Fludarabine(Fludara,Berlex Laboratories): 40 mg/m(2) intravenous (IV) (in the vein) over 30 minutes (in the vein) once daily on Days -6, -5, -4, and -3 or 30 mg/m(2) IV over 30 minutes (in the vein) once daily on Days -6, -5, -4, -3, and -2 Total Body Irradiation (TBI): 200 centigray (cGy) on Day -1 or 300 cGy on Day -1 (for 9/10 URD and Haplo patients) Allogeneic hematopoietic stem cell (HSC): stem cell transplant Healthy related donors =5; recipients = 14.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Pain::Bone
|
10.5%
2/19 • Number of events 4 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Nervous system disorders
Pain::Head/headache
|
15.8%
3/19 • Number of events 4 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
57.9%
11/19 • Number of events 37 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
52.6%
10/19 • Number of events 38 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Metabolism and nutrition disorders
Acidosis (metabolic or respiratory)
|
5.3%
1/19 • Number of events 3 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
26.3%
5/19 • Number of events 20 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
31.6%
6/19 • Number of events 23 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
10.5%
2/19 • Number of events 2 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
26.3%
5/19 • Number of events 12 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Renal and urinary disorders
Bladder spasms
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Blood and lymphatic system disorders
CD4 count
|
5.3%
1/19 • Number of events 3 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Metabolism and nutrition disorders
CPK (creatine phosphokinase)
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Respiratory, thoracic and mediastinal disorders
Carbon monoxide diffusion capacity (DL(co))
|
15.8%
3/19 • Number of events 4 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Cardiac disorders
Cardiac Arrhythmia - Other (Specify, persistent tachycardia)
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Metabolism and nutrition disorders
Cholesterol, serum-high (hypercholesteremia)
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Metabolism and nutrition disorders
Creatinine
|
10.5%
2/19 • Number of events 7 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Renal and urinary disorders
Cystitis
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Skin and subcutaneous tissue disorders
Dermal change lymphedema, phlebolymphedema
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, v dermatitis per biopsy)
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Gastrointestinal disorders
Diarrhea
|
31.6%
6/19 • Number of events 13 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Eye disorders
Dry eye syndrome
|
21.1%
4/19 • Number of events 4 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
10.5%
2/19 • Number of events 3 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Blood and lymphatic system disorders
Edema: limb
|
10.5%
2/19 • Number of events 2 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Gastrointestinal disorders
Enteritis (inflammation of the small bowel)
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Gastrointestinal disorders
Esophagitis
|
15.8%
3/19 • Number of events 3 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Respiratory, thoracic and mediastinal disorders
FEV(1)
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Infections and infestations
Febrile neutropenia
|
15.8%
3/19 • Number of events 11 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
21.1%
4/19 • Number of events 8 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Metabolism and nutrition disorders
GGT (gamma-Glutamyl transpeptidase)
|
21.1%
4/19 • Number of events 4 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, v)
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
15.8%
3/19 • Number of events 48 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Ear and labyrinth disorders
Hearing: patients without baseline audiogram and not enrolled in a monitoring program
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
47.4%
9/19 • Number of events 72 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Metabolism and nutrition disorders
Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Gastrointestinal disorders
Hemorrhage, GI::Lower GI NOS
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory::Nose
|
10.5%
2/19 • Number of events 3 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
General disorders
Hemorrhage/Bleeding - Other (Specify, diathesis)
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Vascular disorders
Hypertension
|
21.1%
4/19 • Number of events 5 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Vascular disorders
Hypotension
|
21.1%
4/19 • Number of events 4 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
26.3%
5/19 • Number of events 9 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Gastrointestinal disorders
Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation)
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Infections and infestations
Infection (documented clinically or microbiologically)
|
10.5%
2/19 • Number of events 2 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Infections and infestations
Infection - Other (Specify, skin:zoster; thrush)
|
10.5%
2/19 • Number of events 2 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Anal/perianal
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Bladder (urinary)
|
10.5%
2/19 • Number of events 2 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Blood
|
47.4%
9/19 • Number of events 21 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Catheter-related
|
10.5%
2/19 • Number of events 5 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Ileum
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Larynx
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)
|
15.8%
3/19 • Number of events 3 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Nose
|
5.3%
1/19 • Number of events 2 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Oral cavity-gums (gingivitis)
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Peritoneal cavity
|
10.5%
2/19 • Number of events 2 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Pharynx
|
5.3%
1/19 • Number of events 2 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Sinus
|
15.8%
3/19 • Number of events 6 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis)
|
10.5%
2/19 • Number of events 2 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Upper aerodigestive NOS
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS
|
15.8%
3/19 • Number of events 4 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS
|
15.8%
3/19 • Number of events 6 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Vulva
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils::Wound
|
5.3%
1/19 • Number of events 3 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Infections and infestations
Infection with unknown ANC::Blood
|
10.5%
2/19 • Number of events 5 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Infections and infestations
Infection with unknown ANC::Brain + Spinal cord (encephalomyelitis)
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Infections and infestations
Infection with unknown ANC::Bronchus
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Infections and infestations
Infection with unknown ANC::Catheter-related
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Infections and infestations
Infection with unknown ANC::Lung (pneumonia)
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Infections and infestations
Infection with unknown ANC::Upper airway NOS
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Nervous system disorders
Leak, cerebrospinal fluid (CSF)
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
36.8%
7/19 • Number of events 90 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Hepatobiliary disorders
Liver dysfunction/failure (clinical)
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Blood and lymphatic system disorders
Lymphedema-related fibrosis
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
47.4%
9/19 • Number of events 126 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Metabolism and nutrition disorders
Magnesium, serum-high (hypermagnesemia)
|
15.8%
3/19 • Number of events 9 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Nervous system disorders
Mood alteration::Agitation
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)::Oral cavity
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)::Oral cavity
|
10.5%
2/19 • Number of events 3 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)::Facial
|
5.3%
1/19 • Number of events 2 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reactions
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Gastrointestinal disorders
Nausea
|
21.1%
4/19 • Number of events 7 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Nervous system disorders
Neuropathy: sensory
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
31.6%
6/19 • Number of events 20 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Eye disorders
Ocular surface disease
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Eye disorders
Ocular/Visual - Other (Specify, decreased vision)
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Blood and lymphatic system disorders
PTT (Partial Thromboplastin Time)
|
21.1%
4/19 • Number of events 6 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Gastrointestinal disorders
Pain::Abdomen NOS
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Gastrointestinal disorders
Pain::Anus
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Musculoskeletal and connective tissue disorders
Pain::Back
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Gastrointestinal disorders
Pain::Dental/teeth/peridontal
|
5.3%
1/19 • Number of events 2 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Musculoskeletal and connective tissue disorders
Pain::Extremity-limb
|
5.3%
1/19 • Number of events 4 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Blood and lymphatic system disorders
Pain::Lymph node
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Musculoskeletal and connective tissue disorders
Pain::Neck
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
General disorders
Pain::Pain NOS
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Skin and subcutaneous tissue disorders
Pain::Skin
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Reproductive system and breast disorders
Pain::Testicle
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Cardiac disorders
Pericarditis
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
31.6%
6/19 • Number of events 23 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Blood and lymphatic system disorders
Platelets
|
31.6%
6/19 • Number of events 37 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
10.5%
2/19 • Number of events 11 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Cardiac disorders
Prolonged QTc interval
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Metabolism and nutrition disorders
Proteinuria
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Cardiac disorders
Pulmonary hypertension
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
47.4%
9/19 • Number of events 13 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Renal and urinary disorders
Renal failure
|
10.5%
2/19 • Number of events 2 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy - possibly related to cancer treatment (Specify, donor cell leukemia)
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
5.3%
1/19 • Number of events 2 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia::Sinus bradycardia
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia::Sinus tachycardia
|
15.8%
3/19 • Number of events 4 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Vascular disorders
Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura [TTP]
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Metabolism and nutrition disorders
Triglyceride, serum-high (hypertriglyceridemia)
|
21.1%
4/19 • Number of events 9 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
10.5%
2/19 • Number of events 2 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Skin and subcutaneous tissue disorders
Urticaria (hives, welts, wheals)
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Reproductive system and breast disorders
Vaginal dryness
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Reproductive system and breast disorders
Vaginal stenosis/length
|
5.3%
1/19 • Number of events 1 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
Gastrointestinal disorders
Vomiting
|
26.3%
5/19 • Number of events 5 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
|
General disorders
Weight loss
|
10.5%
2/19 • Number of events 2 • Date treatment consent signed to date off study, approximately, 91 months.
Data were not collected separately for donors and recipients.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place