Trial Outcomes & Findings for Precision-exercise-prescription for Lung Cancer Patients Undergoing Surgery: The PEP Study (NCT NCT03306992)
NCT ID: NCT03306992
Last Updated: 2026-06-09
Results Overview
Six Minute Walk (6MW) distance is the distance patients can walk indoors on a 25-meter level, smooth-surfaced track over the course of 6 minutes. This outcome will report the mean 6MW distance at hospital discharge (up to 38 days after the initiation of the study intervention), at the 2-Month Post Surgery Visit (up to 5 months from the initiation of the study intervention), and at the 6-Month Post Surgery Visit (up to 9 months from the initiation of the study intervention).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
182 participants
Primary outcome timeframe
Hospital Discharge (up to 38 days after the initiation of the study therapy), 2-Month Post Surgery Visit (up to 5 months after the initiation of the study therapy), and 6-Month Post Surgery Visit (up to 9 months after the initiation of study therapy)
Results posted on
2026-06-09
Participant Flow
Participant milestones
| Measure |
Personalized Exercise Program
Personalized Exercise Program: The PEP intervention involved a combination of home-based exercise as well as in-patient exercise. The exercise modes included basic transfer and calisthenics mobility, aerobic and resistance exercises and were performed in various postures (supine, sitting, standing, and walking) with variable challenges (level walking, bending, inclines, steps, and squatting).
For patients randomized to the Intervention Group (Group 1), the PEP intervention was personalized, implemented, and modified (based on the patients AM-PAC mobility stage) by a licensed physical therapist in face-to-face, virtual, or phone meetings (\~30-40 minutes). An exercise education manual, specifically developed for this study, was used by the physical therapist to educate the patients on all aspects of starting and maintaining the exercise intervention.
|
Standard of Care - No Exercise
For Participants randomized to the Standard of Care Group (Group 2), no personalized exercise program was utilized.
|
|---|---|---|
|
Hospital Discharge to 2 Month Follow up
STARTED
|
92
|
90
|
|
Hospital Discharge to 2 Month Follow up
COMPLETED
|
82
|
85
|
|
Hospital Discharge to 2 Month Follow up
NOT COMPLETED
|
10
|
5
|
|
2 Month to 6 Month Follow up
STARTED
|
82
|
85
|
|
2 Month to 6 Month Follow up
COMPLETED
|
82
|
82
|
|
2 Month to 6 Month Follow up
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Personalized Exercise Program
Personalized Exercise Program: The PEP intervention involved a combination of home-based exercise as well as in-patient exercise. The exercise modes included basic transfer and calisthenics mobility, aerobic and resistance exercises and were performed in various postures (supine, sitting, standing, and walking) with variable challenges (level walking, bending, inclines, steps, and squatting).
For patients randomized to the Intervention Group (Group 1), the PEP intervention was personalized, implemented, and modified (based on the patients AM-PAC mobility stage) by a licensed physical therapist in face-to-face, virtual, or phone meetings (\~30-40 minutes). An exercise education manual, specifically developed for this study, was used by the physical therapist to educate the patients on all aspects of starting and maintaining the exercise intervention.
|
Standard of Care - No Exercise
For Participants randomized to the Standard of Care Group (Group 2), no personalized exercise program was utilized.
|
|---|---|---|
|
Hospital Discharge to 2 Month Follow up
Withdrawal by Subject
|
7
|
2
|
|
Hospital Discharge to 2 Month Follow up
Death
|
0
|
1
|
|
Hospital Discharge to 2 Month Follow up
Did not perform 6MW test
|
3
|
2
|
|
2 Month to 6 Month Follow up
Death
|
0
|
3
|
Baseline Characteristics
Precision-exercise-prescription for Lung Cancer Patients Undergoing Surgery: The PEP Study
Baseline characteristics by cohort
| Measure |
Personalized Exercise Program
n=92 Participants
Personalized Exercise Program: The PEP intervention involved a combination of home-based exercise as well as in-patient exercise. The exercise modes included basic transfer and calisthenics mobility, aerobic and resistance exercises and were performed in various postures (supine, sitting, standing, and walking) with variable challenges (level walking, bending, inclines, steps, and squatting).
For patients randomized to the Intervention Group (Group 1), the PEP intervention was personalized, implemented, and modified (based on the patients AM-PAC mobility stage) by a licensed physical therapist in face-to-face, virtual, or phone meetings (\~30-40 minutes). An exercise education manual, specifically developed for this study, was used by the physical therapist to educate the patients on all aspects of starting and maintaining the exercise intervention.
|
Standard of Care - No Exercise
n=90 Participants
For Participants randomized to the Standard of Care Group (Group 2), no personalized exercise program was utilized.
|
Total
n=182 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.7 years
STANDARD_DEVIATION 14.7 • n=20 Participants
|
62.7 years
STANDARD_DEVIATION 13.0 • n=20 Participants
|
62.7 years
STANDARD_DEVIATION 13.8 • n=40 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=20 Participants
|
57 Participants
n=20 Participants
|
108 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=20 Participants
|
33 Participants
n=20 Participants
|
74 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
86 Participants
n=20 Participants
|
83 Participants
n=20 Participants
|
169 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
86 Participants
n=20 Participants
|
83 Participants
n=20 Participants
|
169 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
92 participants
n=20 Participants
|
90 participants
n=20 Participants
|
182 participants
n=40 Participants
|
|
Rural-Urban Status
Urban
|
82 Participants
n=20 Participants
|
75 Participants
n=20 Participants
|
157 Participants
n=40 Participants
|
|
Rural-Urban Status
Rural
|
10 Participants
n=20 Participants
|
15 Participants
n=20 Participants
|
25 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Hospital Discharge (up to 38 days after the initiation of the study therapy), 2-Month Post Surgery Visit (up to 5 months after the initiation of the study therapy), and 6-Month Post Surgery Visit (up to 9 months after the initiation of study therapy)Six Minute Walk (6MW) distance is the distance patients can walk indoors on a 25-meter level, smooth-surfaced track over the course of 6 minutes. This outcome will report the mean 6MW distance at hospital discharge (up to 38 days after the initiation of the study intervention), at the 2-Month Post Surgery Visit (up to 5 months from the initiation of the study intervention), and at the 6-Month Post Surgery Visit (up to 9 months from the initiation of the study intervention).
Outcome measures
| Measure |
Personalized Exercise Program
n=81 Participants
Personalized Exercise Program: The PEP intervention involved a combination of home-based exercise as well as in-patient exercise. The exercise modes included basic transfer and calisthenics mobility, aerobic and resistance exercises and were performed in various postures (supine, sitting, standing, and walking) with variable challenges (level walking, bending, inclines, steps, and squatting).
For patients randomized to the Intervention Group (Group 1), the PEP intervention was personalized, implemented, and modified (based on the patients AM-PAC mobility stage) by a licensed physical therapist in face-to-face, virtual, or phone meetings (\~30-40 minutes). An exercise education manual, specifically developed for this study, was used by the physical therapist to educate the patients on all aspects of starting and maintaining the exercise intervention.
|
Standard of Care - No Exercise
n=84 Participants
For Participants randomized to the Standard of Care Group (Group 2), no personalized exercise program was utilized.
|
|---|---|---|
|
Mobility Performance - Six Minute Walk (6MW) Distance
Hospital Discharge
|
409.8 meters
Standard Deviation 169.8
|
411.0 meters
Standard Deviation 164.3
|
|
Mobility Performance - Six Minute Walk (6MW) Distance
2-Month Post Surgery Visit
|
490.5 meters
Standard Deviation 127.6
|
475.9 meters
Standard Deviation 129.5
|
|
Mobility Performance - Six Minute Walk (6MW) Distance
6-Month Post Surgery Visit
|
483.1 meters
Standard Deviation 151.9
|
463.3 meters
Standard Deviation 180
|
SECONDARY outcome
Timeframe: Hospital Discharge (up to 38 days after the initiation of the study therapy), 2-Month Post Surgery Visit (up to 5 months after the initiation of the study therapy), and 6-Month Post Surgery Visit (up to 9 months after the initiation of study therapy)This outcome will report the results from the Short Physical Performance Battery (SPPB). This secondary outcome measure is associated with the evaluation of improvement in physical performance is the result of the short physical performance battery test. The SPPB score (ranging from 0 to 12) will be obtained for each patient at the time points described above. A score of 0 indicates the worst performance, and a score of 12 indicates the best performance. This outcome will report median SPPB scores at hospital discharge (up to 38 days after the initiation of the study intervention), at the 2-Month Post Surgery Visit (up to 5 months from the initiation of the study intervention), and at the 6-Month Post Surgery Visit (up to 9 months from the initiation of the study intervention).
Outcome measures
| Measure |
Personalized Exercise Program
n=81 Participants
Personalized Exercise Program: The PEP intervention involved a combination of home-based exercise as well as in-patient exercise. The exercise modes included basic transfer and calisthenics mobility, aerobic and resistance exercises and were performed in various postures (supine, sitting, standing, and walking) with variable challenges (level walking, bending, inclines, steps, and squatting).
For patients randomized to the Intervention Group (Group 1), the PEP intervention was personalized, implemented, and modified (based on the patients AM-PAC mobility stage) by a licensed physical therapist in face-to-face, virtual, or phone meetings (\~30-40 minutes). An exercise education manual, specifically developed for this study, was used by the physical therapist to educate the patients on all aspects of starting and maintaining the exercise intervention.
|
Standard of Care - No Exercise
n=84 Participants
For Participants randomized to the Standard of Care Group (Group 2), no personalized exercise program was utilized.
|
|---|---|---|
|
Evaluate the Change Short Physical Performance Battery (SPPB) Score
Hospital Discharge
|
11 score on a scale
Interval 9.0 to 12.0
|
11.5 score on a scale
Interval 8.5 to 12.0
|
|
Evaluate the Change Short Physical Performance Battery (SPPB) Score
2-Month Post Surgery Visit
|
12 score on a scale
Interval 11.0 to 12.0
|
12 score on a scale
Interval 10.0 to 12.0
|
|
Evaluate the Change Short Physical Performance Battery (SPPB) Score
6-Month Post Surgery Visit
|
12 score on a scale
Interval 11.0 to 12.0
|
12 score on a scale
Interval 11.0 to 12.0
|
SECONDARY outcome
Timeframe: Hospital Discharge (up to 38 days after the initiation of the study therapy), 2-Month Post Surgery Visit (up to 5 months after the initiation of the study therapy), and 6-Month Post Surgery Visit (up to 9 months after the initiation of the study therapy)The FACT-L (Functional Assessment of Cancer Therapy-Lung) questionnaire assesses health-related quality of life (QOL). Total scores range from 0-136, with lower scores representing worse QOL and higher scores representing better QOL. This outcome measure will report mean FACT-L total scores at Hospital Discharge (up to 38 days after the initiation of the study therapy), 2-Month Post Surgery Visit (up to 5 months after the initiation of the study therapy), and 6-Month Post Surgery Visit (up to 9 months after the initiation of the study therapy).
Outcome measures
| Measure |
Personalized Exercise Program
n=81 Participants
Personalized Exercise Program: The PEP intervention involved a combination of home-based exercise as well as in-patient exercise. The exercise modes included basic transfer and calisthenics mobility, aerobic and resistance exercises and were performed in various postures (supine, sitting, standing, and walking) with variable challenges (level walking, bending, inclines, steps, and squatting).
For patients randomized to the Intervention Group (Group 1), the PEP intervention was personalized, implemented, and modified (based on the patients AM-PAC mobility stage) by a licensed physical therapist in face-to-face, virtual, or phone meetings (\~30-40 minutes). An exercise education manual, specifically developed for this study, was used by the physical therapist to educate the patients on all aspects of starting and maintaining the exercise intervention.
|
Standard of Care - No Exercise
n=84 Participants
For Participants randomized to the Standard of Care Group (Group 2), no personalized exercise program was utilized.
|
|---|---|---|
|
FACT-L (Functional Assessment of Cancer Therapy-Lung) Questionnaire
Hospital Discharge
|
100 score on a scale
Standard Deviation 18.1
|
101.5 score on a scale
Standard Deviation 17.0
|
|
FACT-L (Functional Assessment of Cancer Therapy-Lung) Questionnaire
2-Month Follow up
|
106.4 score on a scale
Standard Deviation 14.8
|
103.5 score on a scale
Standard Deviation 17.1
|
|
FACT-L (Functional Assessment of Cancer Therapy-Lung) Questionnaire
6-Month Follow up
|
106.5 score on a scale
Standard Deviation 16
|
105.9 score on a scale
Standard Deviation 15.7
|
SECONDARY outcome
Timeframe: Hospital Discharge (up to 38 days after the initiation of the study therapy), 2-Month Post Surgery Visit (up to 5 months after the initiation of the study therapy), and 6-Month Post Surgery Visit (up to 9 months after the initiation of study therapy)This outcome will report the results of the Fatigue Subscale (FS) from the FACIT-F (Chronic Illness Fatigue Scale) questionnaire. The FACIT-F is a self-reported evaluation of fatigue in cancer patients. This questionnaire has patients rank statements regarding physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns from 0 Not at All to 4 Very Much. This outcome will report the FS score from the FACIT-F. The FS has a minimum of 0 and a maximum of 52; the higher the score the better the Quality of Life (QOL). The FS Score is calculated from 13 survey items. Individual items that were "reverse items" (meaning a high value indicates poor QOL) were subtracted from 4. Then all "reverse items" and normal items were added together to calculate the FS score. This assessment was scored according to the FACIT-F Scoring Guidelines (Version 4).
Outcome measures
| Measure |
Personalized Exercise Program
n=81 Participants
Personalized Exercise Program: The PEP intervention involved a combination of home-based exercise as well as in-patient exercise. The exercise modes included basic transfer and calisthenics mobility, aerobic and resistance exercises and were performed in various postures (supine, sitting, standing, and walking) with variable challenges (level walking, bending, inclines, steps, and squatting).
For patients randomized to the Intervention Group (Group 1), the PEP intervention was personalized, implemented, and modified (based on the patients AM-PAC mobility stage) by a licensed physical therapist in face-to-face, virtual, or phone meetings (\~30-40 minutes). An exercise education manual, specifically developed for this study, was used by the physical therapist to educate the patients on all aspects of starting and maintaining the exercise intervention.
|
Standard of Care - No Exercise
n=84 Participants
For Participants randomized to the Standard of Care Group (Group 2), no personalized exercise program was utilized.
|
|---|---|---|
|
Fatigue Subscale (FS)
Hospital Discharge
|
34.5 score on a scale
Standard Deviation 11.4
|
33.5 score on a scale
Standard Deviation 12.1
|
|
Fatigue Subscale (FS)
2 Month Follow-up Visit
|
38.6 score on a scale
Standard Deviation 8.7
|
36 score on a scale
Standard Deviation 10.7
|
|
Fatigue Subscale (FS)
6-Month Follow-up
|
38.2 score on a scale
Standard Deviation 10.2
|
37.5 score on a scale
Standard Deviation 11.3
|
SECONDARY outcome
Timeframe: Hospital Discharge (up to 38 days after the initiation of the study therapy), 2-Month Post Surgery Visit (up to 5 months after the initiation of the study therapy), and 6-Month Post Surgery Visit (up to 9 months after the initiation of study therapy)This outcome will report the results of the BREQ-3. The questionnaire has 24 items, each item ranging from 0 "Not True for Me" to 4 "Very True for Me". This questionnaire will report 6 sub-scores, Amotivation, External Regulation, Introjected Regulation, Identified Regulation, Integrated Regulation, Intrinsic Regulation. Each sub score is a the average of 4 items, ranging from 0-4 with higher values indicating higher motivation.
Outcome measures
| Measure |
Personalized Exercise Program
n=81 Participants
Personalized Exercise Program: The PEP intervention involved a combination of home-based exercise as well as in-patient exercise. The exercise modes included basic transfer and calisthenics mobility, aerobic and resistance exercises and were performed in various postures (supine, sitting, standing, and walking) with variable challenges (level walking, bending, inclines, steps, and squatting).
For patients randomized to the Intervention Group (Group 1), the PEP intervention was personalized, implemented, and modified (based on the patients AM-PAC mobility stage) by a licensed physical therapist in face-to-face, virtual, or phone meetings (\~30-40 minutes). An exercise education manual, specifically developed for this study, was used by the physical therapist to educate the patients on all aspects of starting and maintaining the exercise intervention.
|
Standard of Care - No Exercise
n=84 Participants
For Participants randomized to the Standard of Care Group (Group 2), no personalized exercise program was utilized.
|
|---|---|---|
|
BREQ-3 (Behavioral Regulation in Exercise Questionnaire 3) Questionnaire
Discharge: External Regulation
|
0.8 score on a scale
Standard Deviation 1.1
|
0.9 score on a scale
Standard Deviation 1.0
|
|
BREQ-3 (Behavioral Regulation in Exercise Questionnaire 3) Questionnaire
Discharge: Amotivation
|
0.2 score on a scale
Standard Deviation 0.5
|
0.2 score on a scale
Standard Deviation 0.5
|
|
BREQ-3 (Behavioral Regulation in Exercise Questionnaire 3) Questionnaire
Discharge: Introjected Regulation
|
1.7 score on a scale
Standard Deviation 1.1
|
1.7 score on a scale
Standard Deviation 1
|
|
BREQ-3 (Behavioral Regulation in Exercise Questionnaire 3) Questionnaire
Discharge: Identified Regulation
|
2.9 score on a scale
Standard Deviation .8
|
2.8 score on a scale
Standard Deviation 0.9
|
|
BREQ-3 (Behavioral Regulation in Exercise Questionnaire 3) Questionnaire
Discharge: Integrated Regulation
|
2.2 score on a scale
Standard Deviation 1.3
|
2.1 score on a scale
Standard Deviation 1.2
|
|
BREQ-3 (Behavioral Regulation in Exercise Questionnaire 3) Questionnaire
Discharge: Intrinsic Regulation
|
2.3 score on a scale
Standard Deviation 1.2
|
2.3 score on a scale
Standard Deviation 1.2
|
|
BREQ-3 (Behavioral Regulation in Exercise Questionnaire 3) Questionnaire
2-Month: Amotivation
|
0.1 score on a scale
Standard Deviation 0.3
|
0.2 score on a scale
Standard Deviation 0.4
|
|
BREQ-3 (Behavioral Regulation in Exercise Questionnaire 3) Questionnaire
2-Month: External Regulation
|
0.8 score on a scale
Standard Deviation 1
|
0.90 score on a scale
Standard Deviation 1
|
|
BREQ-3 (Behavioral Regulation in Exercise Questionnaire 3) Questionnaire
2-Months: Introjected Regulation
|
1.7 score on a scale
Standard Deviation 1.1
|
1.7 score on a scale
Standard Deviation 1.1
|
|
BREQ-3 (Behavioral Regulation in Exercise Questionnaire 3) Questionnaire
2-Months: Identified Regulation
|
3.0 score on a scale
Standard Deviation 0.7
|
2.9 score on a scale
Standard Deviation 0.9
|
|
BREQ-3 (Behavioral Regulation in Exercise Questionnaire 3) Questionnaire
2-Months: Integrated Regulation
|
2.2 score on a scale
Standard Deviation 1.1
|
2.1 score on a scale
Standard Deviation 1.2
|
|
BREQ-3 (Behavioral Regulation in Exercise Questionnaire 3) Questionnaire
2-Months: Intrinsic Regulation
|
2.2 score on a scale
Standard Deviation 1
|
2.3 score on a scale
Standard Deviation 1.1
|
|
BREQ-3 (Behavioral Regulation in Exercise Questionnaire 3) Questionnaire
6-Months: Amotivation
|
0.2 score on a scale
Standard Deviation 0.4
|
0.3 score on a scale
Standard Deviation 0.6
|
|
BREQ-3 (Behavioral Regulation in Exercise Questionnaire 3) Questionnaire
6-Months: External Regulation
|
0.8 score on a scale
Standard Deviation 1.0
|
0.8 score on a scale
Standard Deviation 1.0
|
|
BREQ-3 (Behavioral Regulation in Exercise Questionnaire 3) Questionnaire
6-Months: Introjected Regulation
|
1.9 score on a scale
Standard Deviation 1.1
|
1.8 score on a scale
Standard Deviation 1.2
|
|
BREQ-3 (Behavioral Regulation in Exercise Questionnaire 3) Questionnaire
6-Months: Identified Regulation
|
3.1 score on a scale
Standard Deviation 0.8
|
2.9 score on a scale
Standard Deviation 0.9
|
|
BREQ-3 (Behavioral Regulation in Exercise Questionnaire 3) Questionnaire
6-Months: Integrated Regulation
|
2.4 score on a scale
Standard Deviation 1.2
|
2.3 score on a scale
Standard Deviation 1.1
|
|
BREQ-3 (Behavioral Regulation in Exercise Questionnaire 3) Questionnaire
6-Months: Intrinsic Regulation
|
2.4 score on a scale
Standard Deviation 1.1
|
2.4 score on a scale
Standard Deviation 1.2
|
Adverse Events
Personalized Exercise Program
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Standard of Care - No Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Personalized Exercise Program
n=92 participants at risk
Personalized Exercise Program: The PEP intervention involved a combination of home-based exercise as well as in-patient exercise. The exercise modes included basic transfer and calisthenics mobility, aerobic and resistance exercises and were performed in various postures (supine, sitting, standing, and walking) with variable challenges (level walking, bending, inclines, steps, and squatting).
For patients randomized to the Intervention Group (Group 1), the PEP intervention was personalized, implemented, and modified (based on the patients AM-PAC mobility stage) by a licensed physical therapist in face-to-face, virtual, or phone meetings (\~30-40 minutes). An exercise education manual, specifically developed for this study, was used by the physical therapist to educate the patients on all aspects of starting and maintaining the exercise intervention.
|
Standard of Care - No Exercise
n=90 participants at risk
For Participants randomized to the Standard of Care Group (Group 2), no personalized exercise program was utilized.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.1%
1/92 • Number of events 1 • Adverse event, Safety Adverse Event, and All Cause Mortality data were collected from the initiation of the study intervention to the Month 6 Follow-Up Visit, up to 6 months.
For this low-risk study, adverse events of interest were collected, recorded, and followed as appropriate. This includes any injuries, events, and conditions with a causal relation to the PEP intervention and require medical attention.
|
0.00%
0/90 • Adverse event, Safety Adverse Event, and All Cause Mortality data were collected from the initiation of the study intervention to the Month 6 Follow-Up Visit, up to 6 months.
For this low-risk study, adverse events of interest were collected, recorded, and followed as appropriate. This includes any injuries, events, and conditions with a causal relation to the PEP intervention and require medical attention.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.2%
2/92 • Number of events 2 • Adverse event, Safety Adverse Event, and All Cause Mortality data were collected from the initiation of the study intervention to the Month 6 Follow-Up Visit, up to 6 months.
For this low-risk study, adverse events of interest were collected, recorded, and followed as appropriate. This includes any injuries, events, and conditions with a causal relation to the PEP intervention and require medical attention.
|
0.00%
0/90 • Adverse event, Safety Adverse Event, and All Cause Mortality data were collected from the initiation of the study intervention to the Month 6 Follow-Up Visit, up to 6 months.
For this low-risk study, adverse events of interest were collected, recorded, and followed as appropriate. This includes any injuries, events, and conditions with a causal relation to the PEP intervention and require medical attention.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased cervical spine
|
1.1%
1/92 • Number of events 1 • Adverse event, Safety Adverse Event, and All Cause Mortality data were collected from the initiation of the study intervention to the Month 6 Follow-Up Visit, up to 6 months.
For this low-risk study, adverse events of interest were collected, recorded, and followed as appropriate. This includes any injuries, events, and conditions with a causal relation to the PEP intervention and require medical attention.
|
0.00%
0/90 • Adverse event, Safety Adverse Event, and All Cause Mortality data were collected from the initiation of the study intervention to the Month 6 Follow-Up Visit, up to 6 months.
For this low-risk study, adverse events of interest were collected, recorded, and followed as appropriate. This includes any injuries, events, and conditions with a causal relation to the PEP intervention and require medical attention.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.1%
1/92 • Number of events 1 • Adverse event, Safety Adverse Event, and All Cause Mortality data were collected from the initiation of the study intervention to the Month 6 Follow-Up Visit, up to 6 months.
For this low-risk study, adverse events of interest were collected, recorded, and followed as appropriate. This includes any injuries, events, and conditions with a causal relation to the PEP intervention and require medical attention.
|
0.00%
0/90 • Adverse event, Safety Adverse Event, and All Cause Mortality data were collected from the initiation of the study intervention to the Month 6 Follow-Up Visit, up to 6 months.
For this low-risk study, adverse events of interest were collected, recorded, and followed as appropriate. This includes any injuries, events, and conditions with a causal relation to the PEP intervention and require medical attention.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
1.1%
1/92 • Number of events 1 • Adverse event, Safety Adverse Event, and All Cause Mortality data were collected from the initiation of the study intervention to the Month 6 Follow-Up Visit, up to 6 months.
For this low-risk study, adverse events of interest were collected, recorded, and followed as appropriate. This includes any injuries, events, and conditions with a causal relation to the PEP intervention and require medical attention.
|
0.00%
0/90 • Adverse event, Safety Adverse Event, and All Cause Mortality data were collected from the initiation of the study intervention to the Month 6 Follow-Up Visit, up to 6 months.
For this low-risk study, adverse events of interest were collected, recorded, and followed as appropriate. This includes any injuries, events, and conditions with a causal relation to the PEP intervention and require medical attention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place