Trial Outcomes & Findings for A Research Program Targeting Pre- and Peri-transplant Optimization Program (R-PPOP) (NCT NCT03823651)
NCT ID: NCT03823651
Last Updated: 2024-09-27
Results Overview
Participants were asked to record or report their exercise sessions.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
6 months
Results posted on
2024-09-27
Participant Flow
Participants were recruited from the Duke Adult Bone Marrow Transplant program between May 2019 and November 2021. The first subject was consented on May 6, 2019 and the last subject was consented on November 2, 2021.
29 subjects (16 patients and 13 caregivers) signed the consent form for this study. 5 subjects (3 patients and 2 caregivers) did not begin the study after signing the consent form. 24 subjects began study activity after signing the consent form.
Participant milestones
| Measure |
Patient
These are patients undergoing hematopoetic stem cell transplant. Patients will complete Interval training, undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.
Interval training: Patients will be asked to complete up to 3 x 30-minute structured high intensity interval training aerobic exercise sessions/week. For the first session, patients will come to the Duke Center for Living for in person evaluation and training. After the initial training session in person, a subsequent training session will take place at the patient's home via iPad/iPhone videoconference using a device provided to the patient to provide additional support and the opportunity to answer questions. Subsequent sessions will be done independently by patients, but study staff will be available via iPad/iPhone if questions arise.
Psychiatric consult: Subjects who score below threshold on the PHQ2/PHQ9, PC-PTSD/PCL-5, PROMIS-Depression and/or PROMIS-Anxiety assessments will be referred to a psychiatrist for follow up.
Nutrition/diet evaluation: PG-SGA, ASA24, food group tracking Assessments and Vit D, Vit A, albumin, prealbumin, lipids, A1c levels will be used to provide weekly feedback for one month
Referral to Social Worker: Subjects who score below threshold on the PROMIS-Emotional Support and/or PROMIS-Social Isolation assessments will be referred to a social worker for follow up
|
Caregiver
These are the assigned caregivers for transplant patients. Caregivers will undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.
Psychiatric consult: Subjects who score below threshold on the PHQ2/PHQ9, PC-PTSD/PCL-5, PROMIS-Depression and/or PROMIS-Anxiety assessments will be referred to a psychiatrist for follow up.
Nutrition/diet evaluation: PG-SGA, ASA24, food group tracking Assessments and Vit D, Vit A, albumin, prealbumin, lipids, A1c levels will be used to provide weekly feedback for one month
Referral to Social Worker: Subjects who score below threshold on the PROMIS-Emotional Support and/or PROMIS-Social Isolation assessments will be referred to a social worker for follow up
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
11
|
|
Overall Study
COMPLETED
|
7
|
5
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
Patient
These are patients undergoing hematopoetic stem cell transplant. Patients will complete Interval training, undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.
Interval training: Patients will be asked to complete up to 3 x 30-minute structured high intensity interval training aerobic exercise sessions/week. For the first session, patients will come to the Duke Center for Living for in person evaluation and training. After the initial training session in person, a subsequent training session will take place at the patient's home via iPad/iPhone videoconference using a device provided to the patient to provide additional support and the opportunity to answer questions. Subsequent sessions will be done independently by patients, but study staff will be available via iPad/iPhone if questions arise.
Psychiatric consult: Subjects who score below threshold on the PHQ2/PHQ9, PC-PTSD/PCL-5, PROMIS-Depression and/or PROMIS-Anxiety assessments will be referred to a psychiatrist for follow up.
Nutrition/diet evaluation: PG-SGA, ASA24, food group tracking Assessments and Vit D, Vit A, albumin, prealbumin, lipids, A1c levels will be used to provide weekly feedback for one month
Referral to Social Worker: Subjects who score below threshold on the PROMIS-Emotional Support and/or PROMIS-Social Isolation assessments will be referred to a social worker for follow up
|
Caregiver
These are the assigned caregivers for transplant patients. Caregivers will undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.
Psychiatric consult: Subjects who score below threshold on the PHQ2/PHQ9, PC-PTSD/PCL-5, PROMIS-Depression and/or PROMIS-Anxiety assessments will be referred to a psychiatrist for follow up.
Nutrition/diet evaluation: PG-SGA, ASA24, food group tracking Assessments and Vit D, Vit A, albumin, prealbumin, lipids, A1c levels will be used to provide weekly feedback for one month
Referral to Social Worker: Subjects who score below threshold on the PROMIS-Emotional Support and/or PROMIS-Social Isolation assessments will be referred to a social worker for follow up
|
|---|---|---|
|
Overall Study
Death
|
5
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Caregiver to patient who died
|
0
|
5
|
|
Overall Study
Caregiver to patient who was withdrawn due to physician decision
|
0
|
1
|
Baseline Characteristics
Caregivers were not included in BMI analysis
Baseline characteristics by cohort
| Measure |
Patient
n=13 Participants
These are patients undergoing hematopoetic stem cell transplant. Patients will complete Interval training, undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.
Interval training: Patients will be asked to complete up to 3 x 30-minute structured high intensity interval training aerobic exercise sessions/week. For the first session, patients will come to the Duke Center for Living for in person evaluation and training. After the initial training session in person, a subsequent training session will take place at the patient's home via iPad/iPhone videoconference using a device provided to the patient to provide additional support and the opportunity to answer questions. Subsequent sessions will be done independently by patients, but study staff will be available via iPad/iPhone if questions arise.
Psychiatric consult: Subjects who score below threshold on the PHQ2/PHQ9, PC-PTSD/PCL-5, PROMIS-Depression and/or PROMIS-Anxiety assessments will be referred to a psychiatrist for follow up.
Nutrition/diet evaluation: PG-SGA, ASA24, food group tracking Assessments and Vit D, Vit A, albumin, prealbumin, lipids, A1c levels will be used to provide weekly feedback for one month
Referral to Social Worker: Subjects who score below threshold on the PROMIS-Emotional Support and/or PROMIS-Social Isolation assessments will be referred to a social worker for follow up
|
Caregiver
n=11 Participants
These are the assigned caregivers for transplant patients. Caregivers will undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.
Psychiatric consult: Subjects who score below threshold on the PHQ2/PHQ9, PC-PTSD/PCL-5, PROMIS-Depression and/or PROMIS-Anxiety assessments will be referred to a psychiatrist for follow up.
Nutrition/diet evaluation: PG-SGA, ASA24, food group tracking Assessments and Vit D, Vit A, albumin, prealbumin, lipids, A1c levels will be used to provide weekly feedback for one month
Referral to Social Worker: Subjects who score below threshold on the PROMIS-Emotional Support and/or PROMIS-Social Isolation assessments will be referred to a social worker for follow up
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 Years
STANDARD_DEVIATION 11.6 • n=13 Participants
|
55 Years
STANDARD_DEVIATION 13.8 • n=11 Participants
|
56 Years
STANDARD_DEVIATION 12.6 • n=24 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=13 Participants
|
9 Participants
n=11 Participants
|
12 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=13 Participants
|
2 Participants
n=11 Participants
|
12 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=13 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=13 Participants
|
11 Participants
n=11 Participants
|
24 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=13 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=13 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=13 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=13 Participants
|
3 Participants
n=11 Participants
|
6 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=13 Participants
|
8 Participants
n=11 Participants
|
18 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=13 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=24 Participants
|
|
BMI (body mass index)
|
29.5 kg/m2
STANDARD_DEVIATION 4.8 • n=13 Participants • Caregivers were not included in BMI analysis
|
—
|
29.5 kg/m2
STANDARD_DEVIATION 4.8 • n=13 Participants • Caregivers were not included in BMI analysis
|
|
Weight
|
90.8 kg
STANDARD_DEVIATION 19.7 • n=13 Participants • Caregivers not included in weight analysis
|
—
|
90.8 kg
STANDARD_DEVIATION 19.7 • n=13 Participants • Caregivers not included in weight analysis
|
|
Diagnosis
Myelodysplastic syndrome
|
5 Participants
n=13 Participants • Caregivers are not included in the Diagnosis category
|
—
|
5 Participants
n=13 Participants • Caregivers are not included in the Diagnosis category
|
|
Diagnosis
Acute myeloid leukemia
|
3 Participants
n=13 Participants • Caregivers are not included in the Diagnosis category
|
—
|
3 Participants
n=13 Participants • Caregivers are not included in the Diagnosis category
|
|
Diagnosis
Diffuse large B-cell lymphoma
|
2 Participants
n=13 Participants • Caregivers are not included in the Diagnosis category
|
—
|
2 Participants
n=13 Participants • Caregivers are not included in the Diagnosis category
|
|
Diagnosis
Acute lymphoblastic leukemia
|
1 Participants
n=13 Participants • Caregivers are not included in the Diagnosis category
|
—
|
1 Participants
n=13 Participants • Caregivers are not included in the Diagnosis category
|
|
Diagnosis
Chronic lymphocytic leukemia
|
1 Participants
n=13 Participants • Caregivers are not included in the Diagnosis category
|
—
|
1 Participants
n=13 Participants • Caregivers are not included in the Diagnosis category
|
|
Diagnosis
Peripheral T-cell lymphoma
|
1 Participants
n=13 Participants • Caregivers are not included in the Diagnosis category
|
—
|
1 Participants
n=13 Participants • Caregivers are not included in the Diagnosis category
|
|
Receiving chemotherapy during intervention
Yes
|
10 Participants
n=13 Participants • Caregivers are not included in the chemotherapy during transplant analysis
|
—
|
10 Participants
n=13 Participants • Caregivers are not included in the chemotherapy during transplant analysis
|
|
Receiving chemotherapy during intervention
No
|
3 Participants
n=13 Participants • Caregivers are not included in the chemotherapy during transplant analysis
|
—
|
3 Participants
n=13 Participants • Caregivers are not included in the chemotherapy during transplant analysis
|
|
Work Status
Employed Full-Time
|
4 Participants
n=13 Participants
|
3 Participants
n=11 Participants
|
7 Participants
n=24 Participants
|
|
Work Status
Employed Part-Time
|
0 Participants
n=13 Participants
|
2 Participants
n=11 Participants
|
2 Participants
n=24 Participants
|
|
Work Status
Homemaker
|
0 Participants
n=13 Participants
|
1 Participants
n=11 Participants
|
1 Participants
n=24 Participants
|
|
Work Status
Retired
|
6 Participants
n=13 Participants
|
4 Participants
n=11 Participants
|
10 Participants
n=24 Participants
|
|
Work Status
Unemployed/Disabled
|
2 Participants
n=13 Participants
|
0 Participants
n=11 Participants
|
2 Participants
n=24 Participants
|
|
Work Status
Unemployed/Seeking
|
0 Participants
n=13 Participants
|
1 Participants
n=11 Participants
|
1 Participants
n=24 Participants
|
|
Work Status
Unknown/Not Reported
|
1 Participants
n=13 Participants
|
0 Participants
n=11 Participants
|
1 Participants
n=24 Participants
|
|
Martial Status
Married or living with significant other
|
13 Participants
n=13 Participants
|
10 Participants
n=11 Participants
|
23 Participants
n=24 Participants
|
|
Martial Status
Single, never married
|
0 Participants
n=13 Participants
|
1 Participants
n=11 Participants
|
1 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 13 patients were prescribed the HIIT intervention, but only 9 consistently recorded sessions throughout the duration of the study.
Participants were asked to record or report their exercise sessions.
Outcome measures
| Measure |
Patient
n=9 Participants
These are patients undergoing hematopoetic stem cell transplant. Patients will complete Interval training, undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.
Interval training: Patients will be asked to complete up to 3 x 30-minute structured high intensity interval training aerobic exercise sessions/week. For the first session, patients will come to the Duke Center for Living for in person evaluation and training. After the initial training session in person, a subsequent training session will take place at the patient's home via iPad/iPhone videoconference using a device provided to the patient to provide additional support and the opportunity to answer questions. Subsequent sessions will be done independently by patients, but study staff will be available via iPad/iPhone if questions arise.
Psychiatric consult: Subjects who score below threshold on the PHQ2/PHQ9, PC-PTSD/PCL-5, PROMIS-Depression and/or PROMIS-Anxiety assessments will be referred to a psychiatrist for follow up.
Nutrition/diet evaluation: PG-SGA, ASA24, food group tracking Assessments and Vit D, Vit A, albumin, prealbumin, lipids, A1c levels will be used to provide weekly feedback for one month
Referral to Social Worker: Subjects who score below threshold on the PROMIS-Emotional Support and/or PROMIS-Social Isolation assessments will be referred to a social worker for follow up
|
|---|---|
|
Number of Participants Who Completed at Least Half of Their High Intensity Interval Training Sessions
|
9 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearScored as 0 (No, least severe), 1 (Yes, sometimes) and 2 (Yes, on a regular basis, most severe)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearScored from 0 (least severe) to 4 (most severe)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearParticipants will answer Yes/No to whether they have had any falls in the preceding 6 months
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365, 730Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearBiomarker panel to be analyzed: CRP, Eotaxin, Eotaxin-3, FGF (basic), Flt-1/VEGFR-1, GM-CSF, ICAM-1, IFN-γ, IL-10, IL-12/IL-23p40, IL-12p70, IL-13, IL-15, IL-16, IL-17A, IL-17A/F, IL-17B, IL-17C, IL-17D, IL-1RA, IL-1α, IL-1β, IL-2, IL-21, IL-22, IL-23, IL-27, IL-3, IL-31, IL-4, IL-5, IL-6, IL-7, IL-8, IL-8 (HA), IL-9, IP-10, MCP-1, MCP-4, MDC, MIP-1α, MIP-1β, MIP-3α, PlGF, SAA, TARC, Tie-2, TNF-α, TNF-β, TSLP, VCAM-1, VEGF-A, VEGF-C, VEGF-D
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearAssessment is scored as 0 (never/least severe), 1 (sometimes), 2 (on a regular basis/most severe)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearAssessment is scored from 1 (least severe) to 5 (most severe)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 daysOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 daysOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 daysOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearAssessment is scored from 1 (least severe) to 5 (most severe)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearAssessment is scored from 5 (least severe) to 1 (most severe)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearAssessment is scored from 5 (least severe) to 1 (most severe)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: day 180CPET is scored by measuring changes in V02 max
Outcome measures
Outcome data not reported
Adverse Events
Patient
Serious events: 0 serious events
Other events: 2 other events
Deaths: 5 deaths
Caregiver
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Patient
n=13 participants at risk
These are patients undergoing hematopoetic stem cell transplant. Patients will complete Interval training, undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.
Interval training: Patients will be asked to complete up to 3 x 30-minute structured high intensity interval training aerobic exercise sessions/week. For the first session, patients will come to the Duke Center for Living for in person evaluation and training. After the initial training session in person, a subsequent training session will take place at the patient's home via iPad/iPhone videoconference using a device provided to the patient to provide additional support and the opportunity to answer questions. Subsequent sessions will be done independently by patients, but study staff will be available via iPad/iPhone if questions arise.
Psychiatric consult: Subjects who score below threshold on the PHQ2/PHQ9, PC-PTSD/PCL-5, PROMIS-Depression and/or PROMIS-Anxiety assessments will be referred to a psychiatrist for follow up.
Nutrition/diet evaluation: PG-SGA, ASA24, food group tracking Assessments and Vit D, Vit A, albumin, prealbumin, lipids, A1c levels will be used to provide weekly feedback for one month
Referral to Social Worker: Subjects who score below threshold on the PROMIS-Emotional Support and/or PROMIS-Social Isolation assessments will be referred to a social worker for follow up
|
Caregiver
n=11 participants at risk
These are the assigned caregivers for transplant patients. Caregivers will undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.
Psychiatric consult: Subjects who score below threshold on the PHQ2/PHQ9, PC-PTSD/PCL-5, PROMIS-Depression and/or PROMIS-Anxiety assessments will be referred to a psychiatrist for follow up.
Nutrition/diet evaluation: PG-SGA, ASA24, food group tracking Assessments and Vit D, Vit A, albumin, prealbumin, lipids, A1c levels will be used to provide weekly feedback for one month
Referral to Social Worker: Subjects who score below threshold on the PROMIS-Emotional Support and/or PROMIS-Social Isolation assessments will be referred to a social worker for follow up
|
|---|---|---|
|
Cardiac disorders
Cardiac Arrhythmia
|
7.7%
1/13 • Number of events 1 • Adverse event data was collected for participants from enrollment through 1 year post-transplant
Adverse events are self-reported by study participants. The patients on this study are undergoing allogeneic stem cell transplantation, which is a procedure that is associated with high rates of adverse outcomes and morbidity. As such, we only record adverse events that are directly reported to us by the study participant or that are directly related to the study activity (i.e. falls during 6 minute walk test, emotional distress from answering study questionnaires, etc.)
|
0.00%
0/11 • Adverse event data was collected for participants from enrollment through 1 year post-transplant
Adverse events are self-reported by study participants. The patients on this study are undergoing allogeneic stem cell transplantation, which is a procedure that is associated with high rates of adverse outcomes and morbidity. As such, we only record adverse events that are directly reported to us by the study participant or that are directly related to the study activity (i.e. falls during 6 minute walk test, emotional distress from answering study questionnaires, etc.)
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
7.7%
1/13 • Number of events 1 • Adverse event data was collected for participants from enrollment through 1 year post-transplant
Adverse events are self-reported by study participants. The patients on this study are undergoing allogeneic stem cell transplantation, which is a procedure that is associated with high rates of adverse outcomes and morbidity. As such, we only record adverse events that are directly reported to us by the study participant or that are directly related to the study activity (i.e. falls during 6 minute walk test, emotional distress from answering study questionnaires, etc.)
|
0.00%
0/11 • Adverse event data was collected for participants from enrollment through 1 year post-transplant
Adverse events are self-reported by study participants. The patients on this study are undergoing allogeneic stem cell transplantation, which is a procedure that is associated with high rates of adverse outcomes and morbidity. As such, we only record adverse events that are directly reported to us by the study participant or that are directly related to the study activity (i.e. falls during 6 minute walk test, emotional distress from answering study questionnaires, etc.)
|
|
Surgical and medical procedures
Surgery for hip fracture
|
7.7%
1/13 • Number of events 1 • Adverse event data was collected for participants from enrollment through 1 year post-transplant
Adverse events are self-reported by study participants. The patients on this study are undergoing allogeneic stem cell transplantation, which is a procedure that is associated with high rates of adverse outcomes and morbidity. As such, we only record adverse events that are directly reported to us by the study participant or that are directly related to the study activity (i.e. falls during 6 minute walk test, emotional distress from answering study questionnaires, etc.)
|
0.00%
0/11 • Adverse event data was collected for participants from enrollment through 1 year post-transplant
Adverse events are self-reported by study participants. The patients on this study are undergoing allogeneic stem cell transplantation, which is a procedure that is associated with high rates of adverse outcomes and morbidity. As such, we only record adverse events that are directly reported to us by the study participant or that are directly related to the study activity (i.e. falls during 6 minute walk test, emotional distress from answering study questionnaires, etc.)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place