Trial Outcomes & Findings for Exercise and Stress Management Post Autologous and Allogeneic Transplant (BMT CTN 0902) (NCT NCT01278927)
NCT ID: NCT01278927
Last Updated: 2022-12-08
Results Overview
To determine whether exercise or stress management improves self-reported physical and mental functioning compared to standard care at 100 days post hematopoietic cell transplantation (HCT) using evaluated patients. The Physical Component Score (PCS) and Mental Component Score (MCS) of the SF-36 will be the primary endpoint measures of functional status. Raw scores are converted to a standard metric (0-100), with higher scores being indicative of a better health state.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
711 participants
Primary outcome timeframe
100 days
Results posted on
2022-12-08
Participant Flow
Participant milestones
| Measure |
Exercise
Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
|
Stress Management
Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
|
Exercise and Stress Management
Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
|
Standard Care
Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
180
|
178
|
178
|
175
|
|
Overall Study
COMPLETED
|
180
|
178
|
178
|
175
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exercise and Stress Management Post Autologous and Allogeneic Transplant (BMT CTN 0902)
Baseline characteristics by cohort
| Measure |
Exercise
n=180 Participants
Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
|
Stress Management
n=178 Participants
Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
|
Exercise and Stress Management
n=178 Participants
Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
|
Standard Care
n=175 Participants
Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
|
Total
n=711 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
<=40 years
|
26 participants
n=5 Participants
|
21 participants
n=7 Participants
|
26 participants
n=5 Participants
|
27 participants
n=4 Participants
|
100 participants
n=21 Participants
|
|
Age, Customized
41-<65 years
|
105 participants
n=5 Participants
|
123 participants
n=7 Participants
|
118 participants
n=5 Participants
|
111 participants
n=4 Participants
|
457 participants
n=21 Participants
|
|
Age, Customized
>=65 years
|
49 participants
n=5 Participants
|
34 participants
n=7 Participants
|
34 participants
n=5 Participants
|
37 participants
n=4 Participants
|
154 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
306 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
405 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
172 Participants
n=5 Participants
|
167 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
167 Participants
n=4 Participants
|
673 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
162 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
152 Participants
n=4 Participants
|
626 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Karnofsky Performance-status Score
>=90%
|
112 participants
n=5 Participants
|
111 participants
n=7 Participants
|
94 participants
n=5 Participants
|
102 participants
n=4 Participants
|
419 participants
n=21 Participants
|
|
Karnofsky Performance-status Score
70%-80%
|
65 participants
n=5 Participants
|
64 participants
n=7 Participants
|
76 participants
n=5 Participants
|
68 participants
n=4 Participants
|
273 participants
n=21 Participants
|
|
Karnofsky Performance-status Score
50%-60%
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
4 participants
n=4 Participants
|
10 participants
n=21 Participants
|
|
Karnofsky Performance-status Score
Missing/Not done
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
1 participants
n=4 Participants
|
9 participants
n=21 Participants
|
|
Disease
AML/ANLL/ALL
|
42 participants
n=5 Participants
|
47 participants
n=7 Participants
|
40 participants
n=5 Participants
|
42 participants
n=4 Participants
|
171 participants
n=21 Participants
|
|
Disease
CML
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
14 participants
n=21 Participants
|
|
Disease
MDS/MPS
|
19 participants
n=5 Participants
|
16 participants
n=7 Participants
|
15 participants
n=5 Participants
|
13 participants
n=4 Participants
|
63 participants
n=21 Participants
|
|
Disease
MM/PCD
|
50 participants
n=5 Participants
|
44 participants
n=7 Participants
|
45 participants
n=5 Participants
|
57 participants
n=4 Participants
|
196 participants
n=21 Participants
|
|
Disease
Lymphoma
|
54 participants
n=5 Participants
|
60 participants
n=7 Participants
|
66 participants
n=5 Participants
|
50 participants
n=4 Participants
|
230 participants
n=21 Participants
|
|
Disease
CLL/SLL
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
7 participants
n=4 Participants
|
20 participants
n=21 Participants
|
|
Disease
Solid Tumors
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Disease
SAA
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
9 participants
n=21 Participants
|
|
Disease
Other Disease
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Disease
Missing
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
1 participants
n=4 Participants
|
5 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 100 daysTo determine whether exercise or stress management improves self-reported physical and mental functioning compared to standard care at 100 days post hematopoietic cell transplantation (HCT) using evaluated patients. The Physical Component Score (PCS) and Mental Component Score (MCS) of the SF-36 will be the primary endpoint measures of functional status. Raw scores are converted to a standard metric (0-100), with higher scores being indicative of a better health state.
Outcome measures
| Measure |
Exercise
n=139 Participants
Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
|
Stress Management
n=142 Participants
Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
|
Exercise and Stress Management
n=136 Participants
Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
|
Standard Care
n=143 Participants
Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
|
|---|---|---|---|---|
|
Functional Status
PCS
|
42.2 units on a scale
Standard Deviation 10.47
|
41.8 units on a scale
Standard Deviation 9.59
|
40.6 units on a scale
Standard Deviation 10.49
|
42.5 units on a scale
Standard Deviation 9.22
|
|
Functional Status
MCS
|
50.8 units on a scale
Standard Deviation 10.44
|
52.4 units on a scale
Standard Deviation 9.43
|
52.1 units on a scale
Standard Deviation 9.70
|
50.4 units on a scale
Standard Deviation 10.69
|
SECONDARY outcome
Timeframe: 100 daysPatients will complete the MOS 36-Item Short Form (SF-36), a widely used self-report measure designed to assess perceived health and functioning, contains eight scales: Physical Functioning (PF), Role-Physical (R-P); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Mental Health (MH); and Role-Emotional (R-E). Scales are comprised of different numbers of items and use a variety of rating formats. Raw scores are converted to a standard metric (0-100), with higher scores being indicative of a better health state.
Outcome measures
| Measure |
Exercise
n=139 Participants
Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
|
Stress Management
n=142 Participants
Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
|
Exercise and Stress Management
n=136 Participants
Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
|
Standard Care
n=143 Participants
Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
|
|---|---|---|---|---|
|
Symptoms
Physical Functioning
|
66.46 units on a scale
Standard Deviation 24.47
|
66.12 units on a scale
Standard Deviation 23.95
|
65.83 units on a scale
Standard Deviation 23.34
|
67.38 units on a scale
Standard Deviation 24.30
|
|
Symptoms
Role Physical
|
54.79 units on a scale
Standard Deviation 30.21
|
53.49 units on a scale
Standard Deviation 30.72
|
54.74 units on a scale
Standard Deviation 29.33
|
58.51 units on a scale
Standard Deviation 26.98
|
|
Symptoms
Bodily Pain
|
67.78 units on a scale
Standard Deviation 24.74
|
71.55 units on a scale
Standard Deviation 25.17
|
67.96 units on a scale
Standard Deviation 26.18
|
68.19 units on a scale
Standard Deviation 24.15
|
|
Symptoms
General Health
|
63.62 units on a scale
Standard Deviation 19.93
|
60.05 units on a scale
Standard Deviation 19.86
|
58.06 units on a scale
Standard Deviation 20.25
|
59.43 units on a scale
Standard Deviation 19.38
|
|
Symptoms
Vitality
|
54.91 units on a scale
Standard Deviation 20.84
|
58.13 units on a scale
Standard Deviation 18.29
|
54.42 units on a scale
Standard Deviation 21.03
|
53.56 units on a scale
Standard Deviation 21.06
|
|
Symptoms
Social Functioning
|
73.83 units on a scale
Standard Deviation 25.89
|
76.13 units on a scale
Standard Deviation 26.52
|
72.64 units on a scale
Standard Deviation 26.96
|
72.67 units on a scale
Standard Deviation 26.68
|
|
Symptoms
Role Emotional
|
81.73 units on a scale
Standard Deviation 25.64
|
80.44 units on a scale
Standard Deviation 26.83
|
86.68 units on a scale
Standard Deviation 21.23
|
81.83 units on a scale
Standard Deviation 25.29
|
|
Symptoms
Mental Health
|
76.68 units on a scale
Standard Deviation 17.24
|
80.17 units on a scale
Standard Deviation 15.29
|
77.85 units on a scale
Standard Deviation 17.58
|
76.75 units on a scale
Standard Deviation 17.59
|
SECONDARY outcome
Timeframe: 100 daysCancer and treatment distress will be measured by the acute version of the Cancer and Treatment Distress (CTXD) scale, a 27 item validated measure of distress with domains of Uncertainty, Health Burden, Family Strain, Identity and Managing the Medical System used extensively in HCT studies. The scale ranges from 0 - 3, where a higher score reflects more distress.
Outcome measures
| Measure |
Exercise
n=140 Participants
Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
|
Stress Management
n=144 Participants
Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
|
Exercise and Stress Management
n=138 Participants
Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
|
Standard Care
n=144 Participants
Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
|
|---|---|---|---|---|
|
Cancer and Treatment Distress (CTXD)
|
0.96 units on a scale
Standard Deviation 0.56
|
0.88 units on a scale
Standard Deviation 0.60
|
1.04 units on a scale
Standard Deviation 0.66
|
0.94 units on a scale
Standard Deviation 0.57
|
SECONDARY outcome
Timeframe: 100 daysThe Pittsburgh Sleep Quality Index (PSQI) is a widely used seven item self-report measure of sleep patterns and difficulties. A modified version will be used to obtain self-reports of the following for the past week: sleep quality, sleep latency, sleep efficiency, and use of sleeping medications. The scale ranges from 0 - 21, where a higher score reflects worse sleep quality.
Outcome measures
| Measure |
Exercise
n=132 Participants
Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
|
Stress Management
n=136 Participants
Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
|
Exercise and Stress Management
n=135 Participants
Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
|
Standard Care
n=138 Participants
Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
|
|---|---|---|---|---|
|
The Pittsburgh Sleep Quality Index (PSQI)
|
4.55 units on a scale
Standard Deviation 3.50
|
3.49 units on a scale
Standard Deviation 2.93
|
4.44 units on a scale
Standard Deviation 3.31
|
4.02 units on a scale
Standard Deviation 3.13
|
SECONDARY outcome
Timeframe: 100 daysTwo questions using a similar format as the SF-36 were added to measure nausea. The scale ranges from 1 - 5, where a higher score indicates worse nausea.
Outcome measures
| Measure |
Exercise
n=138 Participants
Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
|
Stress Management
n=143 Participants
Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
|
Exercise and Stress Management
n=138 Participants
Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
|
Standard Care
n=144 Participants
Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
|
|---|---|---|---|---|
|
Nausea
|
2.74 units on a scale
Standard Deviation 1.38
|
2.63 units on a scale
Standard Deviation 1.41
|
2.80 units on a scale
Standard Deviation 1.47
|
2.85 units on a scale
Standard Deviation 1.49
|
SECONDARY outcome
Timeframe: 100 daysThe number of hospital days within the first 100 days after graft infusion will be collected for patients surviving at least 100 days.
Outcome measures
| Measure |
Exercise
n=175 Participants
Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
|
Stress Management
n=172 Participants
Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
|
Exercise and Stress Management
n=172 Participants
Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
|
Standard Care
n=173 Participants
Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
|
|---|---|---|---|---|
|
Days of Hospitalization
|
21.1 days
Standard Deviation 20.3
|
22.7 days
Standard Deviation 19.6
|
21.6 days
Standard Deviation 20.6
|
20.9 days
Standard Deviation 17.0
|
SECONDARY outcome
Timeframe: 6 monthsThe SF-36 PCS and MCS will be collected from participants at six months. Raw scores are converted to a standard metric (0-100), with higher scores being indicative of a better health state.
Outcome measures
| Measure |
Exercise
n=125 Participants
Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
|
Stress Management
n=122 Participants
Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
|
Exercise and Stress Management
n=117 Participants
Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
|
Standard Care
n=128 Participants
Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
|
|---|---|---|---|---|
|
SF-36 Late Outcomes
PCS
|
44.5 units on a scale
Standard Deviation 9.4
|
42.3 units on a scale
Standard Deviation 10.6
|
43.4 units on a scale
Standard Deviation 10.0
|
42.8 units on a scale
Standard Deviation 10.1
|
|
SF-36 Late Outcomes
MCS
|
51.6 units on a scale
Standard Deviation 9.8
|
52.5 units on a scale
Standard Deviation 9.1
|
50.7 units on a scale
Standard Deviation 11.0
|
51.7 units on a scale
Standard Deviation 9.9
|
SECONDARY outcome
Timeframe: 6 months and 1 yearBoth survival at 6 months and overall survival at last follow-up will be reported. Overall survival is defined as the interval between transplantation and death or last follow-up. Patients alive when the study closes or lost to follow up are censored at the date of last contact.
Outcome measures
| Measure |
Exercise
n=180 Participants
Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
|
Stress Management
n=178 Participants
Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
|
Exercise and Stress Management
n=178 Participants
Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
|
Standard Care
n=175 Participants
Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
|
|---|---|---|---|---|
|
Survival
6 months
|
89 percentage of participants
Interval 83.0 to 92.0
|
89 percentage of participants
Interval 84.0 to 93.0
|
86 percentage of participants
Interval 80.0 to 90.0
|
92 percentage of participants
Interval 88.0 to 96.0
|
|
Survival
1 year
|
85 percentage of participants
Interval 79.0 to 90.0
|
82 percentage of participants
Interval 75.0 to 88.0
|
72 percentage of participants
Interval 64.0 to 80.0
|
79 percentage of participants
Interval 70.0 to 86.0
|
Adverse Events
Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stress Management
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Exercise and Stress Management
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Exercise
n=178 participants at risk
Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief (10 minute) personalized introduction to the home-based exercise intervention. On Day 30 post hematopoietic cell transplantation (HCT), participants will meet briefly with the same interventionist when possible. To minimize contamination across intervention conditions, participants randomized to Exercise will be provided with only general advice regarding stress management (i.e., to continue using any techniques they currently use to manage stress). The interventionist will meet with the patient again in person or by phone at approximately 60 days post transplant.
Exercise: Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
|
Stress Management
n=175 participants at risk
Participants will receive a packet of materials from the study interventionist, along with a brief standardized introduction to the self-administered intervention. On Day 30 post HCT, the interventionist will meet with the participant to answer any questions about the intervention, encourage the continued use of stress management techniques as recommended, and monitor for any adverse reactions to use of the techniques. The interventionist will meet with the patient again in person or by phone at approximately 60 days post transplant. Whenever possible, the interventionist meeting with the patient at 30 and 60 days should be the same interventionist who previously met with the patient.
Stress Management: Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
|
Exercise and Stress Management
n=174 participants at risk
Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions. On Day 30 post HCT, the same interventionist will meet with the participant briefly to answer any questions about the interventions, encourage the continued use of the interventions as recommended, and monitor for any adverse reactions. The interventionist will meet with the patient again in person or by phone at approximately 60 days post transplant. Whenever possible, the interventionist meeting with the patient at 30 and 60 days should be the same interventionist who previously met with the patient.
Exercise and Stress Management: Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
|
Standard Care
n=174 participants at risk
Patients randomized to standard care only will be informed of their assigned condition and receive a digital video disc (DVD). The interventionist will briefly discuss the topics of the DVD and elicit questions. To minimize contamination across intervention conditions, participants randomized to the control group will be provided with only general advice about exercise and stress management during treatment (i.e., to maintain any usual patterns of exercise to the extent possible and to continue using any techniques they currently use to manage stress).
Standard Care: Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
|
|---|---|---|---|---|
|
Psychiatric disorders
Depression
|
0.00%
0/178 • 6-months post-transplant
Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event.
|
0.00%
0/175 • 6-months post-transplant
Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event.
|
0.57%
1/174 • 6-months post-transplant
Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event.
|
0.00%
0/174 • 6-months post-transplant
Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place