Trial Outcomes & Findings for A Proposal to Test the Efficacy and Tolerability of Bortezomib in Pulmonary Chronic GVHD (NCT NCT01163786)

NCT ID: NCT01163786

Last Updated: 2020-04-10

Results Overview

FEV1 will be measured by spirometry assessments at baseline (pre-transplant baseline - prior to pulmonary chronic graft-versus-host disease (p-CGVHD)) during treatment (10 weeks) and at follow up visit 9 (at 12 weeks) and at follow up visit 10 (at 18 weeks) with patients having spirometry tested up to 6 times from screening to the end of the study. FEV1 is reported as slopes computed by dividing difference in FEV1 by time in months.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 17 participants
• Primary outcome timeframe: Mean time to diagnosis (from transplant to p-CGVHD ) of 3.36 years (+/- 1.88 years) and up to 18 weeks after baseline
• Results posted on: 2020-04-10

Participant Flow

The study opened for accrual on July 20, 2010 with an accrual goal of up to 20 evaluable patients. The first patient being enrolled on the study on October 7th 2010. The study was closed permanently on August 31 2015 before the accrual goal was met with 17 patients being treated on study.

Patients were diagnosed with pulmonary Chronic Graft Verses Host Disease (p-CGVHD) after having undergone allogeneic hematopoietic stem cell transplant (HSCT). Patients were required to be less than 100 days post HSCT, with an absolute decrease of 12% or more in forced expiratory volume in 1 second (FEV1) from pre-transplant baseline.

Participant milestones

Measure	Bortezomib Patients will receive 2 cycles of Bortezomib (given weekly for 4 weeks) for a total of 8 doses of Bortezomib. Each cycle will consist of weekly bortezomib with a 2 week interval between cycles. Bortezomib: Each patient will receive 2 cycles of Bortezomib. For each cycle Bortezomib will be given once a week, 1.3mg/m2 for 4 weeks with 2 weeks between each cycle.
Treatment With Bortezomib STARTED	17
Treatment With Bortezomib Completed 1st Cycle	17
Treatment With Bortezomib Completed 2nd Cycle	14
Treatment With Bortezomib COMPLETED	14
Treatment With Bortezomib NOT COMPLETED	3
Completed Follow up (Visit 9 and 10) STARTED	14
Completed Follow up (Visit 9 and 10) Completed Week 12 Follow up (Visit 9)	14
Completed Follow up (Visit 9 and 10) Completed Week 18 Follow up (Visit 10)	13
Completed Follow up (Visit 9 and 10) COMPLETED	13
Completed Follow up (Visit 9 and 10) NOT COMPLETED	1

Reasons for withdrawal

Measure	Bortezomib Patients will receive 2 cycles of Bortezomib (given weekly for 4 weeks) for a total of 8 doses of Bortezomib. Each cycle will consist of weekly bortezomib with a 2 week interval between cycles. Bortezomib: Each patient will receive 2 cycles of Bortezomib. For each cycle Bortezomib will be given once a week, 1.3mg/m2 for 4 weeks with 2 weeks between each cycle.
Treatment With Bortezomib Withdrawal by Subject	1
Treatment With Bortezomib Adverse Event	2
Completed Follow up (Visit 9 and 10) Other	1

Baseline Characteristics

A Proposal to Test the Efficacy and Tolerability of Bortezomib in Pulmonary Chronic GVHD

Baseline characteristics by cohort

Measure	Bortezomib n=17 Participants Patients will receive 2 cycles of Bortezomib (given weekly for 4 weeks) for a total of 8 doses of Bortezomib. Each cycle will consist of weekly bortezomib with a 2 week interval between cycles. Bortezomib: Each patient will receive 2 cycles of Bortezomib. For each cycle Bortezomib will be given once a week, 1.3mg/m2 for 4 weeks with 2 weeks between each cycle.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=93 Participants
Age, Categorical >=65 years	2 Participants n=93 Participants
Sex: Female, Male Female	4 Participants n=93 Participants
Sex: Female, Male Male	13 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	15 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants
Region of Enrollment United States	17 participants n=93 Participants
Disease Acute Leukemia	6 Participants n=93 Participants
Disease Chronic Myelogenous Leukemia	3 Participants n=93 Participants
Disease Lymophoma	4 Participants n=93 Participants
Disease Myeloma	2 Participants n=93 Participants
Disease Other	2 Participants n=93 Participants
Sex Matching of Transplantation Female-female	1 Participants n=93 Participants
Sex Matching of Transplantation Female-male	3 Participants n=93 Participants
Sex Matching of Transplantation male-female	5 Participants n=93 Participants
Sex Matching of Transplantation male-male	8 Participants n=93 Participants
Transplant Type Matched Sibling	12 Participants n=93 Participants
Transplant Type Matched unrelated	4 Participants n=93 Participants
Transplant Type Mini matched unrelated	1 Participants n=93 Participants
Plumonary Function Testing (PFT) at time of transplant Forced Expiratory Volume in 1 Second (FEV1)	90 percentage STANDARD_DEVIATION 17 • n=93 Participants
Plumonary Function Testing (PFT) at time of transplant Forced Vital Capacity (FVC)	89 percentage STANDARD_DEVIATION 18 • n=93 Participants
Plumonary Function Testing (PFT) at time of transplant FEV/FVC	81 percentage STANDARD_DEVIATION 5 • n=93 Participants
lumonary Function Testing at time of pulmonary Chronic Graft-verses-host disease (pGVHD) Diagnosis Forced Expiratory Volume in 1 Second (FEV1)	47 percentage STANDARD_DEVIATION 16 • n=93 Participants
lumonary Function Testing at time of pulmonary Chronic Graft-verses-host disease (pGVHD) Diagnosis Forced Vital Capacity (FVC)	60 percentage STANDARD_DEVIATION 15 • n=93 Participants
lumonary Function Testing at time of pulmonary Chronic Graft-verses-host disease (pGVHD) Diagnosis FEV/FVC	61 percentage STANDARD_DEVIATION 14 • n=93 Participants
Time from transplant to pGVHD diagnosis	3.36 years STANDARD_DEVIATION 1.88 • n=93 Participants

PRIMARY outcome

Timeframe: Mean time to diagnosis (from transplant to p-CGVHD ) of 3.36 years (+/- 1.88 years) and up to 18 weeks after baseline

FEV1 will be measured by spirometry assessments at baseline (pre-transplant baseline - prior to pulmonary chronic graft-versus-host disease (p-CGVHD)) during treatment (10 weeks) and at follow up visit 9 (at 12 weeks) and at follow up visit 10 (at 18 weeks) with patients having spirometry tested up to 6 times from screening to the end of the study. FEV1 is reported as slopes computed by dividing difference in FEV1 by time in months.

Outcome measures

Measure	Bortezomib n=17 Participants Patients will receive 2 cycles of Bortezomib (given weekly for 4 weeks) for a total of 8 doses of Bortezomib. Each cycle will consist of weekly bortezomib with a 2 week interval between cycles. Bortezomib: Each patient will receive 2 cycles of Bortezomib. For each cycle Bortezomib will be given once a week, 1.3mg/m2 for 4 weeks with 2 weeks between each cycle.
Change in Pulmonary Function as Measured by Forced Expiratory Volume in 1 Second (FEV1) Decline During Treatment with Bortezomib	-0.25 percentage per month Interval -9.42 to 3.52
Change in Pulmonary Function as Measured by Forced Expiratory Volume in 1 Second (FEV1) Decline Prior to diagnosis of p-CGVHD	-1.06 percentage per month Interval -5.36 to -0.33

SECONDARY outcome

Timeframe: Up to 18 weeks from baseline

Population: Data was collected but not analyzed due to the study closing before accrual was met. Below is data on how many patients started 6 minute walk and how many patients stopped before reaching 6 minutes at each time point is shown below.

Patients will have an exercise tolerance assessment defined as a 6 minute walk completed at cycle 1 (week 1) and cycle 2 (week 5) of treatment and visit 9 (12 weeks) and visit 10 (18 weeks).

Outcome measures

Measure	Bortezomib n=13 Participants Patients will receive 2 cycles of Bortezomib (given weekly for 4 weeks) for a total of 8 doses of Bortezomib. Each cycle will consist of weekly bortezomib with a 2 week interval between cycles. Bortezomib: Each patient will receive 2 cycles of Bortezomib. For each cycle Bortezomib will be given once a week, 1.3mg/m2 for 4 weeks with 2 weeks between each cycle.
Exercise Tolerance- 6 Minute Walk Cycle 1 (Visit 1): Started 6 Minute walk	13 participants
Exercise Tolerance- 6 Minute Walk Cycle 1 (Visit 1): Stopped before 6 minutes	3 participants
Exercise Tolerance- 6 Minute Walk Cycle 1(Visit 1):Declined walk	0 participants
Exercise Tolerance- 6 Minute Walk Cycle 2 (Visit 5) : Started 6 Minute walk	3 participants
Exercise Tolerance- 6 Minute Walk Cycle 2 (Visit 5) : Stopped before 6 minutes	0 participants
Exercise Tolerance- 6 Minute Walk Cycle 2(Visit 5):Declined walk	0 participants
Exercise Tolerance- 6 Minute Walk Follow up/Visit 9: Started 6 Minute walk	6 participants
Exercise Tolerance- 6 Minute Walk Follow up/Visit 9 : Stopped before 6 minutes	1 participants
Exercise Tolerance- 6 Minute Walk Follow up/Visit 9: Declined walk	1 participants
Exercise Tolerance- 6 Minute Walk Follow up/Visit 10 : Started 6 Minute walk	5 participants
Exercise Tolerance- 6 Minute Walk Follow up/Visit 10 : Stopped before 6 minutes	1 participants
Exercise Tolerance- 6 Minute Walk Follow up/Visit 10: Declined walk	1 participants

SECONDARY outcome

Timeframe: up to 18 weeks

Population: Data was collected but not analyzed. Averages for each patient at each timepoint are shown below. N/a is shown for timepoints where data was not collected.

This is a quality of life questionnaire which yields scores for 8 domains (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health). This questionnaire will be completed by patients on Visit 1 (week 1), Visit 5 (week 5), Visit 8 (week 8), Visit 9 (12 weeks), and Visit 10 (18 weeks).

Questionnaires were scored per the scoring rules for the RAND 36-Item Health Survey (version 1.0) A high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. Items that are left blank (missing data) are not taken into account when calculating the scale scores. Hence, scale scores represent the average for all items in the scale that the respondent answered.

Outcome measures

Measure	Bortezomib n=17 Participants Patients will receive 2 cycles of Bortezomib (given weekly for 4 weeks) for a total of 8 doses of Bortezomib. Each cycle will consist of weekly bortezomib with a 2 week interval between cycles. Bortezomib: Each patient will receive 2 cycles of Bortezomib. For each cycle Bortezomib will be given once a week, 1.3mg/m2 for 4 weeks with 2 weeks between each cycle.
Short Form (SF)-36 Health Survey Pt #3 : Social Functioning : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #3 : Social Functioning : Visit 9	87.5 Average Score
Short Form (SF)-36 Health Survey Pt #3 Pain : Visit 1	90 Average Score
Short Form (SF)-36 Health Survey Pt #3 Pain : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #3 Pain : Visit 8	100 Average Score
Short Form (SF)-36 Health Survey Pt #3 Pain : Visit 9	100 Average Score
Short Form (SF)-36 Health Survey Pt #3 : General Health : Visit 5	20 Average Score
Short Form (SF)-36 Health Survey Pt #3 : General Health : Visit 8	31.25 Average Score
Short Form (SF)-36 Health Survey Pt #4 : Physical Functioning : Visit 9	50 Average Score
Short Form (SF)-36 Health Survey Pt #4 : Role-physcial : Visit 1	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #4 : Role-physcial : Visit 5	25 Average Score
Short Form (SF)-36 Health Survey Pt #4 : Role-physcial : Visit 8	100 Average Score
Short Form (SF)-36 Health Survey Pt #7: Energy/fatigue : Visit 10	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #4 : Role-physcial : Visit 9	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #4 : Role-emotional : Visit 1	33.33 Average Score
Short Form (SF)-36 Health Survey Pt #4 : Role-emotional : Visit 9	33.33 Average Score
Short Form (SF)-36 Health Survey Pt #4 : Role-emotional : Visit 10	33.33 Average Score
Short Form (SF)-36 Health Survey Pt #4 : Energy/fatigue : Visit 5	35 Average Score
Short Form (SF)-36 Health Survey Pt #4 : Energy/fatigue : Visit 8	35 Average Score
Short Form (SF)-36 Health Survey Pt #4 : Energy/fatigue : Visit 10	35 Average Score
Short Form (SF)-36 Health Survey Pt #4 : Emotional Well-being : Visit 1	60 Average Score
Short Form (SF)-36 Health Survey Pt #4 : Emotional Well-being : Visit 5	56 Average Score
Short Form (SF)-36 Health Survey Pt #4 : Emotional Well-being : Visit 8	72 Average Score
Short Form (SF)-36 Health Survey Pt #4 : Emotional Well-being : Visit 9	66.67 Average Score
Short Form (SF)-36 Health Survey Pt #4 : Emotional Well-being : Visit 10	60 Average Score
Short Form (SF)-36 Health Survey Pt #4 : Social Functioning : Visit 5	37.5 Average Score
Short Form (SF)-36 Health Survey Pt #4 : Social Functioning : Visit 8	50 Average Score
Short Form (SF)-36 Health Survey Pt #4 : Pain : Visit 1	22.5 Average Score
Short Form (SF)-36 Health Survey Pt #4 : Pain : Visit 5	20 Average Score
Short Form (SF)-36 Health Survey Pt #4 : Pain : Visit 9	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #4 : Pain : Visit 10	55 Average Score
Short Form (SF)-36 Health Survey Pt #4 : General Health : Visit 1	35 Average Score
Short Form (SF)-36 Health Survey Pt #4 : General Health : Visit 5	35 Average Score
Short Form (SF)-36 Health Survey Pt #4 : General Health : Visit 8	30 Average Score
Short Form (SF)-36 Health Survey Pt #5: Physical Functioning : Visit 1	10 Average Score
Short Form (SF)-36 Health Survey Pt #5: Physical Functioning : Visit 5	20 Average Score
Short Form (SF)-36 Health Survey Pt #5: Physical Functioning : Visit 8	15 Average Score
Short Form (SF)-36 Health Survey Pt #5: Role-physical : Visit 5	0 Average Score
Short Form (SF)-36 Health Survey Pt #5: Role-physical : Visit 8	0 Average Score
Short Form (SF)-36 Health Survey Pt #5: Role-physical : Visit 10	0 Average Score
Short Form (SF)-36 Health Survey Pt #5: Role-emotional : Visit 1	33.33 Average Score
Short Form (SF)-36 Health Survey Pt #5: Energy/fatigue : Visit 5	30 Average Score
Short Form (SF)-36 Health Survey Pt #5: Emotional Well-being : Visit 9	64 Average Score
Short Form (SF)-36 Health Survey Pt #5: Social Functioning : Visit 5	50 Average Score
Short Form (SF)-36 Health Survey Pt #5: Social Functioning : Visit 9	12.5 Average Score
Short Form (SF)-36 Health Survey Pt #5: Social Functioning : Visit 10	12.5 Average Score
Short Form (SF)-36 Health Survey Pt #5: Pain : Visit 10	10 Average Score
Short Form (SF)-36 Health Survey Pt #5: General Health : Visit 1	25 Average Score
Short Form (SF)-36 Health Survey Pt #5: General Health : Visit 10	25 Average Score
Short Form (SF)-36 Health Survey Pt #6: Physical Functioning : Visit 1	22.22 Average Score
Short Form (SF)-36 Health Survey Pt #6: Physical Functioning : Visit 5	27.78 Average Score
Short Form (SF)-36 Health Survey Pt #6: Physical Functioning : Visit 8	20 Average Score
Short Form (SF)-36 Health Survey Pt #6: Physical Functioning : Visit 9	15 Average Score
Short Form (SF)-36 Health Survey Pt #6: Role-physical : Visit 1	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #6: Role-physical : Visit 8	0 Average Score
Short Form (SF)-36 Health Survey Pt #6: Role-physical : Visit 10	0 Average Score
Short Form (SF)-36 Health Survey Pt #6: Role-emotional : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #6: Role-emotional : Visit 8	0 Average Score
Short Form (SF)-36 Health Survey Pt #6: Role-emotional : Visit 10	33.3 Average Score
Short Form (SF)-36 Health Survey Pt #6: Energy/fatigue : Visit 1	10 Average Score
Short Form (SF)-36 Health Survey Pt #6: Energy/fatigue : Visit 5	10 Average Score
Short Form (SF)-36 Health Survey Pt #6: Energy/fatigue : Visit 9	10 Average Score
Short Form (SF)-36 Health Survey Pt #6: Energy/fatigue : Visit 10	0 Average Score
Short Form (SF)-36 Health Survey Pt #7: Emotional Well-being : Visit 1	72 Average Score
Short Form (SF)-36 Health Survey Pt #6: Emotional Well-being : Visit 8	64 Average Score
Short Form (SF)-36 Health Survey Pt #6: Emotional Well-being : Visit 9	64 Average Score
Short Form (SF)-36 Health Survey Pt #6: Emotional Well-being : Visit 10	36 Average Score
Short Form (SF)-36 Health Survey Pt #6: Social Functioning : Visit 8	25 Average Score
Short Form (SF)-36 Health Survey Pt #6: Social Functioning : Visit 9	37.5 Average Score
Short Form (SF)-36 Health Survey Pt #6: Social Functioning : Visit 10	25 Average Score
Short Form (SF)-36 Health Survey Pt #6: Pain : Visit 1	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #6: Pain : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #6: General Health : Visit 10	15 Average Score
Short Form (SF)-36 Health Survey Pt #7: Physical Functioning : Visit 1	20 Average Score
Short Form (SF)-36 Health Survey Pt #7: Physical Functioning : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #7: Physical Functioning : Visit 9	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #7: Physical Functioning : Visit 10	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #7: Role-physical : Visit 1	100 Average Score
Short Form (SF)-36 Health Survey Pt #7: Role-physical : Visit 5	25 Average Score
Short Form (SF)-36 Health Survey Pt #7: Role-emotional : Visit 1	100 Average Score
Short Form (SF)-36 Health Survey Pt #7: Role-emotional : Visit 5	100 Average Score
Short Form (SF)-36 Health Survey Pt #7: Role-emotional : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #7: Role-emotional : Visit 9	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #7: Role-emotional : Visit 10	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #7: Energy/fatigue : Visit 5	10 Average Score
Short Form (SF)-36 Health Survey Pt #7: Energy/fatigue : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #7: Energy/fatigue : Visit 9	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #7: Emotional Well-being : Visit 5	88 Average Score
Short Form (SF)-36 Health Survey Pt #7: Emotional Well-being : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #7: Emotional Well-being : Visit 9	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #7: Emotional Well-being : Visit 10	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #7: Social Functioning : Visit 1	50 Average Score
Short Form (SF)-36 Health Survey Pt #7: Social Functioning : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #7: Social Functioning : Visit 9	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #7: Social Functioning : Visit 10	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #7: Pain : Visit 1	77.5 Average Score
Short Form (SF)-36 Health Survey Pt #7: Pain : Visit 5	77.5 Average Score
Short Form (SF)-36 Health Survey Pt #7: Pain : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #7: Pain : Visit 9	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #7: Pain : Visit 10	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #7: General Health : Visit 1	30 Average Score
Short Form (SF)-36 Health Survey Pt #7: General Health : Visit 5	35 Average Score
Short Form (SF)-36 Health Survey Pt #7: General Health : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #7: General Health : Visit 9	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #7: General Health : Visit 10	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #8: Physical Functioning : Visit 1	45 Average Score
Short Form (SF)-36 Health Survey Pt #8: Physical Functioning : Visit 8	45 Average Score
Short Form (SF)-36 Health Survey Pt #8: Physical Functioning : Visit 9	70 Average Score
Short Form (SF)-36 Health Survey Pt #8: Physical Functioning : Visit 10	45 Average Score
Short Form (SF)-36 Health Survey Pt #8 Role-physcial : Visit 1	0 Average Score
Short Form (SF)-36 Health Survey Pt #8 Role-physcial : Visit 5	33.33 Average Score
Short Form (SF)-36 Health Survey Pt #8 Role-physcial : Visit 8	66.67 Average Score
Short Form (SF)-36 Health Survey Pt #8: Role-emotional : Visit 1	0 Average Score
Short Form (SF)-36 Health Survey Pt #8: Role-emotional : Visit 5	50 Average Score
Short Form (SF)-36 Health Survey Pt #8: Role-emotional : Visit 9	45 Average Score
Short Form (SF)-36 Health Survey Pt #8: Role-emotional : Visit 10	50 Average Score
Short Form (SF)-36 Health Survey Pt #8: Energy/fatigue : Visit 10	50 Average Score
Short Form (SF)-36 Health Survey Pt #8 : Emotional Well-being : Visit 5	60 Average Score
Short Form (SF)-36 Health Survey Pt #8 : Emotional Well-being : Visit 8	52 Average Score
Short Form (SF)-36 Health Survey Pt #8 : Emotional Well-being : Visit 9	92 Average Score
Short Form (SF)-36 Health Survey Pt #8 : Emotional Well-being : Visit 10	92 Average Score
Short Form (SF)-36 Health Survey Pt #8: Social Functioning : Visit 1	50 Average Score
Short Form (SF)-36 Health Survey Pt #8: Social Functioning : Visit 8	50 Average Score
Short Form (SF)-36 Health Survey Pt #8: Social Functioning : Visit 9	75 Average Score
Short Form (SF)-36 Health Survey Pt #8: Social Functioning : Visit 10	87.5 Average Score
Short Form (SF)-36 Health Survey Pt #8 Pain : Visit 1	45 Average Score
Short Form (SF)-36 Health Survey Pt #8 Pain : Visit 5	45 Average Score
Short Form (SF)-36 Health Survey Pt #8 Pain : Visit 8	45 Average Score
Short Form (SF)-36 Health Survey Pt #8 Pain : Visit 10	90 Average Score
Short Form (SF)-36 Health Survey Pt #8: General Health : Visit 1	45 Average Score
Short Form (SF)-36 Health Survey Pt #8: General Health : Visit 5	50 Average Score
Short Form (SF)-36 Health Survey Pt #8: General Health : Visit 8	55 Average Score
Short Form (SF)-36 Health Survey Pt #8: General Health : Visit 10	65 Average Score
Short Form (SF)-36 Health Survey Pt #9: Physical Functioning : Visit 1	75 Average Score
Short Form (SF)-36 Health Survey Pt #9: Physical Functioning : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #9: Physical Functioning : Visit 8	70 Average Score
Short Form (SF)-36 Health Survey Pt #9: Physical Functioning : Visit 9	70 Average Score
Short Form (SF)-36 Health Survey Pt #9: Physical Functioning : Visit 10	80 Average Score
Short Form (SF)-36 Health Survey Pt #9: Role-physical : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #9: Role-physical : Visit 8	0 Average Score
Short Form (SF)-36 Health Survey Pt #9: Role-physical : Visit 9	25 Average Score
Short Form (SF)-36 Health Survey Pt #9: Role-physical : Visit 10	100 Average Score
Short Form (SF)-36 Health Survey Pt #9: Role-emotional : Visit 1	100 Average Score
Short Form (SF)-36 Health Survey Pt #9: Role-emotional : Visit 10	100 Average Score
Short Form (SF)-36 Health Survey Pt #9: Energy/fatigue : Visit 1	70 Average Score
Short Form (SF)-36 Health Survey Pt #9: Energy/fatigue : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #9: Energy/fatigue : Visit 8	60 Average Score
Short Form (SF)-36 Health Survey Pt #9: Emotional Well-being : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #9: Emotional Well-being : Visit 8	80 Average Score
Short Form (SF)-36 Health Survey Pt #9: Emotional Well-being : Visit 9	92 Average Score
Short Form (SF)-36 Health Survey Pt #9: Emotional Well-being : Visit 10	80 Average Score
Short Form (SF)-36 Health Survey Pt #9: Social Functioning : Visit 1	75 Average Score
Short Form (SF)-36 Health Survey Pt #9: Social Functioning : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #9: Social Functioning : Visit 9	87.5 Average Score
Short Form (SF)-36 Health Survey Pt #9: Social Functioning : Visit 10	75 Average Score
Short Form (SF)-36 Health Survey Pt #9: Pain : Visit 1	77.5 Average Score
Short Form (SF)-36 Health Survey Pt #9: Pain : Visit 8	45 Average Score
Short Form (SF)-36 Health Survey Pt #9: Pain : Visit 10	67.5 Average Score
Short Form (SF)-36 Health Survey Pt #9: General Health : Visit 1	70 Average Score
Short Form (SF)-36 Health Survey Pt #9: General Health : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #9: General Health : Visit 8	31.25 Average Score
Short Form (SF)-36 Health Survey Pt #9: General Health : Visit 9	40 Average Score
Short Form (SF)-36 Health Survey Pt #10: Physical Functioning : Visit 1	80 Average Score
Short Form (SF)-36 Health Survey Pt #10: Physical Functioning : Visit 5	90 Average Score
Short Form (SF)-36 Health Survey Pt #10: Physical Functioning : Visit 8	83.33 Average Score
Short Form (SF)-36 Health Survey Pt #10: Physical Functioning : Visit 10	85 Average Score
Short Form (SF)-36 Health Survey Pt #10: Role-physical : Visit 1	0 Average Score
Short Form (SF)-36 Health Survey Pt #10: Role-physical : Visit 5	25 Average Score
Short Form (SF)-36 Health Survey Pt #10: Role-physical : Visit 9	25 Average Score
Short Form (SF)-36 Health Survey Pt #10: Role-physical : Visit 10	100 Average Score
Short Form (SF)-36 Health Survey Pt #10: Role-emotional : Visit 1	100 Average Score
Short Form (SF)-36 Health Survey Pt #10: Role-emotional : Visit 5	100 Average Score
Short Form (SF)-36 Health Survey Pt #10: Role-emotional : Visit 8	100 Average Score
Short Form (SF)-36 Health Survey Pt #10: Role-emotional : Visit 9	100 Average Score
Short Form (SF)-36 Health Survey Pt #10: Emotional Well-being : Visit 9	92 Average Score
Short Form (SF)-36 Health Survey Pt #10: Emotional Well-being : Visit 10	92 Average Score
Short Form (SF)-36 Health Survey Pt #10 : Social Functioning : Visit 10	87.5 Average Score
Short Form (SF)-36 Health Survey Pt #10 Visit 1 : General Health : Visit 8	65 Average Score
Short Form (SF)-36 Health Survey Pt #11 Visit 1 : Physical Functioning : Visit 1	15 Average Score
Short Form (SF)-36 Health Survey Pt #10: Role-emotional : Visit 10	100 Average Score
Short Form (SF)-36 Health Survey Pt #3 : Social Functioning : Visit 8	62.5 Average Score
Short Form (SF)-36 Health Survey Pt #3 : Social Functioning : Visit 10	75 Average Score
Short Form (SF)-36 Health Survey Pt #10: Energy/fatigue : Visit 1	60 Average Score
Short Form (SF)-36 Health Survey Pt #10: Energy/fatigue : Visit 5	75 Average Score
Short Form (SF)-36 Health Survey Pt #10: Energy/fatigue : Visit 8	80 Average Score
Short Form (SF)-36 Health Survey Pt #10: Energy/fatigue : Visit 9	65 Average Score
Short Form (SF)-36 Health Survey Pt #10: Energy/fatigue : Visit 10	80 Average Score
Short Form (SF)-36 Health Survey Pt #10: Emotional Well-being : Visit 1	88 Average Score
Short Form (SF)-36 Health Survey Pt #10: Emotional Well-being : Visit 5	84 Average Score
Short Form (SF)-36 Health Survey Pt #10: Emotional Well-being : Visit 8	84 Average Score
Short Form (SF)-36 Health Survey Pt #10 : Social Functioning : Visit 1	87.5 Average Score
Short Form (SF)-36 Health Survey Pt #10 : Social Functioning : Visit 5	87.5 Average Score
Short Form (SF)-36 Health Survey Pt #10 : Social Functioning : Visit 8	87.5 Average Score
Short Form (SF)-36 Health Survey Pt #10 : Social Functioning : Visit 9	75 Average Score
Short Form (SF)-36 Health Survey Pt #10 Pain : Visit 1	100 Average Score
Short Form (SF)-36 Health Survey Pt #10 Pain : Visit 5	77.5 Average Score
Short Form (SF)-36 Health Survey Pt #10 Pain : Visit 8	77.5 Average Score
Short Form (SF)-36 Health Survey Pt #10 Pain : Visit 9	77.5 Average Score
Short Form (SF)-36 Health Survey Pt #10 Pain : Visit 10	100 Average Score
Short Form (SF)-36 Health Survey Pt #10 Visit 1 : General Health : Visit 1	80 Average Score
Short Form (SF)-36 Health Survey Pt #10 Visit 1 : General Health : Visit 5	65 Average Score
Short Form (SF)-36 Health Survey Pt #10 Visit 1 : General Health : Visit 9	65 Average Score
Short Form (SF)-36 Health Survey Pt #10 Visit 1 : General Health : Visit 10	65 Average Score
Short Form (SF)-36 Health Survey Pt #11 Visit 1 : Physical Functioning : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #11 Visit 1 : Physical Functioning : Visit 8	10 Average Score
Short Form (SF)-36 Health Survey Pt #11 Visit 1 : Physical Functioning : Visit 9	5 Average Score
Short Form (SF)-36 Health Survey Pt #11 Visit 1 : Physical Functioning : Visit 10	10 Average Score
Short Form (SF)-36 Health Survey Pt #11 Visit 1 : Role-physical : Visit 1	25 Average Score
Short Form (SF)-36 Health Survey Pt #11 Visit 1 : Role-physical : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #11 Visit 1 : Role-physical : Visit 8	25 Average Score
Short Form (SF)-36 Health Survey Pt #11 Visit 1 : Role-physical : Visit 9	0 Average Score
Short Form (SF)-36 Health Survey Pt #11 Visit 1 : Role-physical : Visit 10	25 Average Score
Short Form (SF)-36 Health Survey Pt #11 Visit 1 : Role-emotional : Visit 1	0 Average Score
Short Form (SF)-36 Health Survey Pt #11 Visit 1 : Role-emotional : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #11 Visit 1 : Role-emotional : Visit 8	100 Average Score
Short Form (SF)-36 Health Survey Pt #11 Visit 1 : Role-emotional : Visit 9	0 Average Score
Short Form (SF)-36 Health Survey Pt #11 Visit 1 : Role-emotional : Visit 10	66.67 Average Score
Short Form (SF)-36 Health Survey Pt #11 Visit 1 : Energy/fatigue : Visit 1	30 Average Score
Short Form (SF)-36 Health Survey Pt #11 Visit 1 : Energy/fatigue : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #11 Visit 1 : Energy/fatigue : Visit 8	40 Average Score
Short Form (SF)-36 Health Survey Pt #11 Visit 1 : Energy/fatigue : Visit 9	20 Average Score
Short Form (SF)-36 Health Survey Pt #11 Visit 1 : Energy/fatigue : Visit 10	20 Average Score
Short Form (SF)-36 Health Survey Pt #11 Emotional Well-being : Visit 1	60 Average Score
Short Form (SF)-36 Health Survey Pt #11 Emotional Well-being : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #11 Emotional Well-being : Visit 8	84 Average Score
Short Form (SF)-36 Health Survey Pt #11 Emotional Well-being : Visit 9	60 Average Score
Short Form (SF)-36 Health Survey Pt #11 Emotional Well-being : Visit 10	68 Average Score
Short Form (SF)-36 Health Survey Pt #11 Social Functioning : Visit 1	50 Average Score
Short Form (SF)-36 Health Survey Pt #11 Social Functioning : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #11 Social Functioning : Visit 8	87.5 Average Score
Short Form (SF)-36 Health Survey Pt #11 Social Functioning : Visit 9	37.5 Average Score
Short Form (SF)-36 Health Survey Pt #11 Social Functioning : Visit 10	62.5 Average Score
Short Form (SF)-36 Health Survey Pt #11 Visit 1 : Pain : Visit 1	0 Average Score
Short Form (SF)-36 Health Survey Pt #11 Visit 1 : Pain : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #11 Visit 1 : Pain : Visit 8	22.5 Average Score
Short Form (SF)-36 Health Survey Pt #11 Visit 1 : Pain : Visit 9	10 Average Score
Short Form (SF)-36 Health Survey Pt #11 Visit 1 : Pain : Visit 10	22.5 Average Score
Short Form (SF)-36 Health Survey Pt #11 General Health : Visit 1	5 Average Score
Short Form (SF)-36 Health Survey Pt #11 General Health : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #11 General Health : Visit 8	15 Average Score
Short Form (SF)-36 Health Survey Pt #11 General Health : Visit 9	10 Average Score
Short Form (SF)-36 Health Survey Pt #11 General Health : Visit 10	15 Average Score
Short Form (SF)-36 Health Survey Pt #12 Physical Functioning : Visit 1	35 Average Score
Short Form (SF)-36 Health Survey Pt #12 Physical Functioning : Visit 5	50 Average Score
Short Form (SF)-36 Health Survey Pt #12 Physical Functioning : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #12 Physical Functioning : Visit 9	40 Average Score
Short Form (SF)-36 Health Survey Pt #12 Physical Functioning : Visit 10	44.44 Average Score
Short Form (SF)-36 Health Survey Pt #12 Role-physical : Visit 1	0 Average Score
Short Form (SF)-36 Health Survey Pt #12 Role-physical : Visit 5	0 Average Score
Short Form (SF)-36 Health Survey Pt #12 Role-physical : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #12 Role-physical : Visit 9	75 Average Score
Short Form (SF)-36 Health Survey Pt #12 Role-physical : Visit 10	0 Average Score
Short Form (SF)-36 Health Survey Pt #12 Role-emotional : Visit 1	33.33 Average Score
Short Form (SF)-36 Health Survey Pt #12 Role-emotional : Visit 5	100 Average Score
Short Form (SF)-36 Health Survey Pt #12 Role-emotional : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #12 Role-emotional : Visit 9	100 Average Score
Short Form (SF)-36 Health Survey Pt #12 Role-emotional : Visit 10	100 Average Score
Short Form (SF)-36 Health Survey Pt #12 Energy/fatigue : Visit 1	40 Average Score
Short Form (SF)-36 Health Survey Pt #12 Energy/fatigue : Visit 5	60 Average Score
Short Form (SF)-36 Health Survey Pt #12 Energy/fatigue : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #12 Energy/fatigue : Visit 9	65 Average Score
Short Form (SF)-36 Health Survey Pt #12 Energy/fatigue : Visit 10	70 Average Score
Short Form (SF)-36 Health Survey Pt #12 Emotional Well-being : Visit 1	68 Average Score
Short Form (SF)-36 Health Survey Pt #12 Emotional Well-being : Visit 5	80 Average Score
Short Form (SF)-36 Health Survey Pt #12 Emotional Well-being : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #12 Emotional Well-being : Visit 9	72 Average Score
Short Form (SF)-36 Health Survey Pt #12 Emotional Well-being : Visit 10	80 Average Score
Short Form (SF)-36 Health Survey Pt #12 Social Functioning : Visit 1	50 Average Score
Short Form (SF)-36 Health Survey Pt #12 Social Functioning : Visit 5	87.5 Average Score
Short Form (SF)-36 Health Survey Pt #12 Social Functioning : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #12 Social Functioning : Visit 9	87.5 Average Score
Short Form (SF)-36 Health Survey Pt #12 Social Functioning : Visit 10	87.5 Average Score
Short Form (SF)-36 Health Survey Pt #12 Pain : Visit 1	77.5 Average Score
Short Form (SF)-36 Health Survey Pt #12 Pain : Visit 5	55 Average Score
Short Form (SF)-36 Health Survey Pt #12 Pain : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #12 Pain : Visit 9	67.5 Average Score
Short Form (SF)-36 Health Survey Pt #12 Pain : Visit 10	77.5 Average Score
Short Form (SF)-36 Health Survey Pt #12 General Health : Visit 1	60 Average Score
Short Form (SF)-36 Health Survey Pt #12 General Health : Visit 5	45 Average Score
Short Form (SF)-36 Health Survey Pt #12 General Health : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #12 General Health : Visit 9	50 Average Score
Short Form (SF)-36 Health Survey Pt #12 General Health : Visit 10	55 Average Score
Short Form (SF)-36 Health Survey Pt#13 Physical Functioning : Visit 1	20 Average Score
Short Form (SF)-36 Health Survey Pt#13 Physical Functioning : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt#13 Physical Functioning : Visit 8	15 Average Score
Short Form (SF)-36 Health Survey Pt#13 Physical Functioning : Visit 9	10 Average Score
Short Form (SF)-36 Health Survey Pt#13 Physical Functioning : Visit 10	15 Average Score
Short Form (SF)-36 Health Survey Pt #13 Role-physical : Visit 1	25 Average Score
Short Form (SF)-36 Health Survey Pt #13 Role-physical : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #13 Role-physical : Visit 8	0 Average Score
Short Form (SF)-36 Health Survey Pt #13 Role-physical : Visit 9	0 Average Score
Short Form (SF)-36 Health Survey Pt #13 Role-physical : Visit 10	0 Average Score
Short Form (SF)-36 Health Survey Pt #13 Role-emotional : Visit 1	33.33 Average Score
Short Form (SF)-36 Health Survey Pt #13 Role-emotional : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #13 Role-emotional : Visit 8	0 Average Score
Short Form (SF)-36 Health Survey Pt #13 Role-emotional : Visit 9	100 Average Score
Short Form (SF)-36 Health Survey Pt #13 Role-emotional : Visit 10	100 Average Score
Short Form (SF)-36 Health Survey Pt #13 Energy/fatigue : Visit 1	40 Average Score
Short Form (SF)-36 Health Survey Pt #13 Energy/fatigue : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #13 Energy/fatigue : Visit 8	25 Average Score
Short Form (SF)-36 Health Survey Pt #13 Energy/fatigue : Visit 9	25 Average Score
Short Form (SF)-36 Health Survey Pt #13 Energy/fatigue : Visit 10	10 Average Score
Short Form (SF)-36 Health Survey Pt #13 Emotional Well-being : Visit 1	60 Average Score
Short Form (SF)-36 Health Survey Pt #13 Emotional Well-being : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #13 Emotional Well-being : Visit 8	60 Average Score
Short Form (SF)-36 Health Survey Pt #13 Emotional Well-being : Visit 9	64 Average Score
Short Form (SF)-36 Health Survey Pt #13 Emotional Well-being : Visit 10	72 Average Score
Short Form (SF)-36 Health Survey Pt #13 Social Functioning : Visit 1	62.5 Average Score
Short Form (SF)-36 Health Survey Pt #13 Social Functioning : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #13 Social Functioning : Visit 8	62.5 Average Score
Short Form (SF)-36 Health Survey Pt #13 Social Functioning : Visit 9	62.5 Average Score
Short Form (SF)-36 Health Survey Pt #13 Social Functioning : Visit 10	62.5 Average Score
Short Form (SF)-36 Health Survey Pt #13 Pain : Visit 1	67.5 Average Score
Short Form (SF)-36 Health Survey Pt #13 Pain : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #13 Pain : Visit 8	10 Average Score
Short Form (SF)-36 Health Survey Pt #13 Pain : Visit 9	32.5 Average Score
Short Form (SF)-36 Health Survey Pt #13 Pain : Visit 10	45 Average Score
Short Form (SF)-36 Health Survey Pt #13 General Health : Visit 1	20 Average Score
Short Form (SF)-36 Health Survey Pt #13 General Health : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #13 General Health : Visit 8	10 Average Score
Short Form (SF)-36 Health Survey Pt #13 General Health : Visit 9	15 Average Score
Short Form (SF)-36 Health Survey Pt #13 General Health : Visit 10	15 Average Score
Short Form (SF)-36 Health Survey Pt #14 Physical Functioning : Visit 1	80 Average Score
Short Form (SF)-36 Health Survey Pt #14 Physical Functioning : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #14 Physical Functioning : Visit 8	45 Average Score
Short Form (SF)-36 Health Survey Pt #14 Physical Functioning : Visit 9	50 Average Score
Short Form (SF)-36 Health Survey Pt #14 Physical Functioning : Visit 10	60 Average Score
Short Form (SF)-36 Health Survey Pt #14 Role-physical : Visit 1	100 Average Score
Short Form (SF)-36 Health Survey Pt #14 Role-physical : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #14 Role-physical : Visit 8	0 Average Score
Short Form (SF)-36 Health Survey Pt #14 Role-physical : Visit 9	0 Average Score
Short Form (SF)-36 Health Survey Pt #14 Role-physical : Visit 10	50 Average Score
Short Form (SF)-36 Health Survey Pt #14 Role-emotional : Visit 1	0 Average Score
Short Form (SF)-36 Health Survey Pt #14 Role-emotional : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #14 Role-emotional : Visit 8	0 Average Score
Short Form (SF)-36 Health Survey Pt #14 Role-emotional : Visit 9	33.33 Average Score
Short Form (SF)-36 Health Survey Pt #14 Role-emotional : Visit 10	100 Average Score
Short Form (SF)-36 Health Survey Pt #14 Energy/fatigue : Visit 1	60 Average Score
Short Form (SF)-36 Health Survey Pt #14 Energy/fatigue : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #14 Energy/fatigue : Visit 8	50 Average Score
Short Form (SF)-36 Health Survey Pt #14 Energy/fatigue : Visit 9	35 Average Score
Short Form (SF)-36 Health Survey Pt #14 Energy/fatigue : Visit 10	75 Average Score
Short Form (SF)-36 Health Survey Pt #14 Emotional Well-being : Visit 1	56 Average Score
Short Form (SF)-36 Health Survey Pt #14 Emotional Well-being : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #14 Emotional Well-being : Visit 8	64 Average Score
Short Form (SF)-36 Health Survey Pt #14 Emotional Well-being : Visit 9	52 Average Score
Short Form (SF)-36 Health Survey Pt #14 Emotional Well-being : Visit 10	92 Average Score
Short Form (SF)-36 Health Survey Pt #14 Social Functioning : Visit 1	100 Average Score
Short Form (SF)-36 Health Survey Pt #14 Social Functioning : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #14 Social Functioning : Visit 8	62.5 Average Score
Short Form (SF)-36 Health Survey Pt #14 Social Functioning : Visit 9	62.5 Average Score
Short Form (SF)-36 Health Survey Pt #14 Social Functioning : Visit 10	62.5 Average Score
Short Form (SF)-36 Health Survey Pt #14 Pain : Visit 1	100 Average Score
Short Form (SF)-36 Health Survey Pt #14 Pain : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #14 Pain : Visit 8	32.5 Average Score
Short Form (SF)-36 Health Survey Pt #14 Pain : Visit 9	45 Average Score
Short Form (SF)-36 Health Survey Pt #14 Pain : Visit 10	32.5 Average Score
Short Form (SF)-36 Health Survey Pt #14 General Health : Visit 1	50 Average Score
Short Form (SF)-36 Health Survey Pt #14 General Health : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #14 General Health : Visit 8	50 Average Score
Short Form (SF)-36 Health Survey Pt #14 General Health : Visit 9	40 Average Score
Short Form (SF)-36 Health Survey Pt #14 General Health : Visit 10	60 Average Score
Short Form (SF)-36 Health Survey Pt #15 Physical Functioning : Visit 1	10 Average Score
Short Form (SF)-36 Health Survey Pt #15 Physical Functioning : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #15 Physical Functioning : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #15 Physical Functioning : Visit 9	5 Average Score
Short Form (SF)-36 Health Survey Pt #15 Physical Functioning : Visit 10	11.11 Average Score
Short Form (SF)-36 Health Survey Pt #15 Role-physical : Visit 1	0 Average Score
Short Form (SF)-36 Health Survey Pt #15 Role-physical : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #15 Role-physical : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #15 Role-physical : Visit 9	0 Average Score
Short Form (SF)-36 Health Survey Pt #15 Role-physical : Visit 10	25 Average Score
Short Form (SF)-36 Health Survey Pt #15 Role-emotional : Visit 1	66.67 Average Score
Short Form (SF)-36 Health Survey Pt #15 Role-emotional : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #15 Role-emotional : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #15 Role-emotional : Visit 9	66.67 Average Score
Short Form (SF)-36 Health Survey Pt #15 Role-emotional : Visit 10	100 Average Score
Short Form (SF)-36 Health Survey Pt #15 Energy/fatigue : Visit 1	0 Average Score
Short Form (SF)-36 Health Survey Pt #15 Energy/fatigue : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #15 Energy/fatigue : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #15 Energy/fatigue : Visit 9	0 Average Score
Short Form (SF)-36 Health Survey Pt #15 Energy/fatigue : Visit 10	0 Average Score
Short Form (SF)-36 Health Survey Pt #15 Emotional Well-being : Visit 1	88 Average Score
Short Form (SF)-36 Health Survey Pt #15 Emotional Well-being : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #15 Emotional Well-being : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #15 Emotional Well-being : Visit 9	88 Average Score
Short Form (SF)-36 Health Survey Pt #15 Emotional Well-being : Visit 10	80 Average Score
Short Form (SF)-36 Health Survey Pt #15 Social Functioning : Visit 1	37.5 Average Score
Short Form (SF)-36 Health Survey Pt #15 Social Functioning : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #15 Social Functioning : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #15 Social Functioning : Visit 9	50 Average Score
Short Form (SF)-36 Health Survey Pt #15 Social Functioning : Visit 10	50 Average Score
Short Form (SF)-36 Health Survey Pt #15 Pain : Visit 1	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #15 Pain : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #15 Pain : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #15 Pain : Visit 9	70 Average Score
Short Form (SF)-36 Health Survey Pt #15 Pain : Visit 10	22.5 Average Score
Short Form (SF)-36 Health Survey Pt #15 General Health : Visit 1	15 Average Score
Short Form (SF)-36 Health Survey Pt #15 General Health : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #15 General Health : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #15 General Health : Visit 9	15 Average Score
Short Form (SF)-36 Health Survey Pt #15 General Health : Visit 10	10 Average Score
Short Form (SF)-36 Health Survey Pt #16 Physical Functioning : Visit 1	30 Average Score
Short Form (SF)-36 Health Survey Pt #16 Physical Functioning : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #16 Physical Functioning : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #16 Physical Functioning : Visit 9	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #16 Physical Functioning : Visit 10	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #16 Role-physical : Visit 1	25 Average Score
Short Form (SF)-36 Health Survey Pt #16 Role-physical : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #16 Role-physical : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #16 Role-physical : Visit 9	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #16 Role-physical : Visit 10	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #16 Role-emotional : Visit 1	0 Average Score
Short Form (SF)-36 Health Survey Pt #16 Role-emotional : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #16 Role-emotional : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #16 Role-emotional : Visit 9	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #16 Role-emotional : Visit 10	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #16 Energy/fatigue : Visit 1	20 Average Score
Short Form (SF)-36 Health Survey Pt #16 Energy/fatigue : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #16 Energy/fatigue : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #16 Energy/fatigue : Visit 9	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #16 Energy/fatigue : Visit 10	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #16 Emotional Well-being : Visit 1	48 Average Score
Short Form (SF)-36 Health Survey Pt #16 Emotional Well-being : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #16 Emotional Well-being : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #16 Emotional Well-being : Visit 9	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #16 Emotional Well-being : Visit 10	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #16 Social Functioning : Visit 1	0 Average Score
Short Form (SF)-36 Health Survey Pt #16 Social Functioning : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #16 Social Functioning : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #16 Social Functioning : Visit 9	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #16 Social Functioning : Visit 10	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #16 Pain : Visit 1	22.5 Average Score
Short Form (SF)-36 Health Survey Pt #16 Pain : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #16 Pain : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #16 Pain : Visit 9	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #16 Pain : Visit 10	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #16 General Health : Visit 1	25 Average Score
Short Form (SF)-36 Health Survey Pt #16 General Health : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #16 General Health : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #16 General Health : Visit 9	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #16 General Health : Visit 10	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #17 Physical Functioning : Visit 1	95 Average Score
Short Form (SF)-36 Health Survey Pt #17 Physical Functioning : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #17 Physical Functioning : Visit 8	88.89 Average Score
Short Form (SF)-36 Health Survey Pt #17 Physical Functioning : Visit 9	85 Average Score
Short Form (SF)-36 Health Survey Pt #17 Physical Functioning : Visit 10	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #17 Role-physical : Visit 1	50 Average Score
Short Form (SF)-36 Health Survey Pt #17 Role-physical : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #17 Role-physical : Visit 8	100 Average Score
Short Form (SF)-36 Health Survey Pt #17 Role-physical : Visit 9	75 Average Score
Short Form (SF)-36 Health Survey Pt #17 Role-physical : Visit 10	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #17 Role-emotional : Visit 1	66.67 Average Score
Short Form (SF)-36 Health Survey Pt #17 Role-emotional : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #17 Role-emotional : Visit 8	100 Average Score
Short Form (SF)-36 Health Survey Pt #17 Role-emotional : Visit 9	100 Average Score
Short Form (SF)-36 Health Survey Pt #17 Role-emotional : Visit 10	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #17 Energy/fatigue : Visit 1	70 Average Score
Short Form (SF)-36 Health Survey Pt #17 Energy/fatigue : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #17 Energy/fatigue : Visit 8	40 Average Score
Short Form (SF)-36 Health Survey Pt #17 Energy/fatigue : Visit 9	35 Average Score
Short Form (SF)-36 Health Survey Pt #17 Energy/fatigue : Visit 10	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #17 Emotional Well-being : Visit 1	96 Average Score
Short Form (SF)-36 Health Survey Pt #17 Emotional Well-being : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #17 Emotional Well-being : Visit 8	76 Average Score
Short Form (SF)-36 Health Survey Pt #17 Emotional Well-being : Visit 9	76 Average Score
Short Form (SF)-36 Health Survey Pt #17 Emotional Well-being : Visit 10	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #17 Social Functioning : Visit 1	87.5 Average Score
Short Form (SF)-36 Health Survey Pt #17 Social Functioning : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #17 Social Functioning : Visit 8	50 Average Score
Short Form (SF)-36 Health Survey Pt #17 Social Functioning : Visit 9	50 Average Score
Short Form (SF)-36 Health Survey Pt #17 Social Functioning : Visit 10	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #17 Pain : Visit 1	100 Average Score
Short Form (SF)-36 Health Survey Pt #17 Pain : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #17 Pain : Visit 8	100 Average Score
Short Form (SF)-36 Health Survey Pt #17 Pain : Visit 9	75 Average Score
Short Form (SF)-36 Health Survey Pt #17 Pain : Visit 10	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #17 General Health : Visit 1	55 Average Score
Short Form (SF)-36 Health Survey Pt #17 General Health : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #17 General Health : Visit 8	70 Average Score
Short Form (SF)-36 Health Survey Pt #17 General Health : Visit 9	55 Average Score
Short Form (SF)-36 Health Survey Pt #17 General Health : Visit 10	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #3 Pain : Visit 10	90 Average Score
Short Form (SF)-36 Health Survey Pt #3 : General Health : Visit 1	10 Average Score
Short Form (SF)-36 Health Survey Pt #3 : General Health : Visit 9	20 Average Score
Short Form (SF)-36 Health Survey Pt #3 : General Health : Visit 10	20 Average Score
Short Form (SF)-36 Health Survey Pt #4 : Physical Functioning : Visit 1	45 Average Score
Short Form (SF)-36 Health Survey Pt #4 : Physical Functioning : Visit 5	60 Average Score
Short Form (SF)-36 Health Survey Pt #4 : Physical Functioning : Visit 8	33.33 Average Score
Short Form (SF)-36 Health Survey Pt #4 : Physical Functioning : Visit 10	50 Average Score
Short Form (SF)-36 Health Survey Pt #4 : Role-physcial : Visit 10	75 Average Score
Short Form (SF)-36 Health Survey Pt #4 : Role-emotional : Visit 5	0 Average Score
Short Form (SF)-36 Health Survey Pt #4 : Role-emotional : Visit 8	0 Average Score
Short Form (SF)-36 Health Survey Pt #4 : Energy/fatigue : Visit 1	25 Average Score
Short Form (SF)-36 Health Survey Pt #4 : Energy/fatigue : Visit 9	30 Average Score
Short Form (SF)-36 Health Survey Pt #4 : Social Functioning : Visit 1	25 Average Score
Short Form (SF)-36 Health Survey Pt #4 : Social Functioning : Visit 9	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #4 : Social Functioning : Visit 10	50 Average Score
Short Form (SF)-36 Health Survey Pt #4 : Pain : Visit 8	67.5 Average Score
Short Form (SF)-36 Health Survey Pt #4 : General Health : Visit 9	40 Average Score
Short Form (SF)-36 Health Survey Pt #4 : General Health : Visit 10	30 Average Score
Short Form (SF)-36 Health Survey Pt #5: Physical Functioning : Visit 9	10 Average Score
Short Form (SF)-36 Health Survey Pt #5: Physical Functioning : Visit 10	15 Average Score
Short Form (SF)-36 Health Survey Pt #5: Role-physical : Visit 1	0 Average Score
Short Form (SF)-36 Health Survey Pt #5: Role-physical : Visit 9	0 Average Score
Short Form (SF)-36 Health Survey Pt #5: Role-emotional : Visit 5	0 Average Score
Short Form (SF)-36 Health Survey Pt #5: Role-emotional : Visit 8	33.33 Average Score
Short Form (SF)-36 Health Survey Pt #5: Role-emotional : Visit 9	33.33 Average Score
Short Form (SF)-36 Health Survey Pt #5: Role-emotional : Visit 10	33.33 Average Score
Short Form (SF)-36 Health Survey Pt #5: Energy/fatigue : Visit 1	25 Average Score
Short Form (SF)-36 Health Survey Pt #5: Energy/fatigue : Visit 8	20 Average Score
Short Form (SF)-36 Health Survey Pt #5: Energy/fatigue : Visit 9	0 Average Score
Short Form (SF)-36 Health Survey Pt #5: Energy/fatigue : Visit 10	15 Average Score
Short Form (SF)-36 Health Survey Pt #5: Emotional Well-being : Visit 1	72 Average Score
Short Form (SF)-36 Health Survey Pt #5: Emotional Well-being : Visit 5	76 Average Score
Short Form (SF)-36 Health Survey Pt #5: Emotional Well-being : Visit 8	68 Average Score
Short Form (SF)-36 Health Survey Pt #5: Emotional Well-being : Visit 10	68 Average Score
Short Form (SF)-36 Health Survey Pt #5: Social Functioning : Visit 1	12.5 Average Score
Short Form (SF)-36 Health Survey Pt #5: Social Functioning : Visit 8	37.5 Average Score
Short Form (SF)-36 Health Survey Pt #5: Pain : Visit 1	22.5 Average Score
Short Form (SF)-36 Health Survey Pt #5: Pain : Visit 5	35 Average Score
Short Form (SF)-36 Health Survey Pt #5: Pain : Visit 8	22.5 Average Score
Short Form (SF)-36 Health Survey Pt #5: Pain : Visit 9	32.5 Average Score
Short Form (SF)-36 Health Survey Pt #5: General Health : Visit 5	20 Average Score
Short Form (SF)-36 Health Survey Pt #5: General Health : Visit 8	15 Average Score
Short Form (SF)-36 Health Survey Pt #5: General Health : Visit 9	20 Average Score
Short Form (SF)-36 Health Survey Pt #6: Physical Functioning : Visit 10	0 Average Score
Short Form (SF)-36 Health Survey Pt #6: Role-physical : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #6: Role-physical : Visit 9	0 Average Score
Short Form (SF)-36 Health Survey Pt #6: Role-emotional : Visit 1	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #6: Role-emotional : Visit 9	100 Average Score
Short Form (SF)-36 Health Survey Pt #6: Energy/fatigue : Visit 8	15 Average Score
Short Form (SF)-36 Health Survey Pt #6: Emotional Well-being : Visit 1	46.67 Average Score
Short Form (SF)-36 Health Survey Pt #6: Emotional Well-being : Visit 5	60 Average Score
Short Form (SF)-36 Health Survey Pt #6: Social Functioning : Visit 1	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #6: Social Functioning : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #6: Pain : Visit 8	100 Average Score
Short Form (SF)-36 Health Survey Pt #6: Pain : Visit 9	100 Average Score
Short Form (SF)-36 Health Survey Pt #6: Pain : Visit 10	55 Average Score
Short Form (SF)-36 Health Survey Pt #6: General Health : Visit 1	20 Average Score
Short Form (SF)-36 Health Survey Pt #6: General Health : Visit 5	20 Average Score
Short Form (SF)-36 Health Survey Pt #6: General Health : Visit 8	20 Average Score
Short Form (SF)-36 Health Survey Pt #6: General Health : Visit 9	15 Average Score
Short Form (SF)-36 Health Survey Pt #7: Physical Functioning : Visit 5	55 Average Score
Short Form (SF)-36 Health Survey Pt #7: Role-physical : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #7: Role-physical : Visit 9	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #7: Role-physical : Visit 10	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #7: Energy/fatigue : Visit 1	65 Average Score
Short Form (SF)-36 Health Survey Pt #7: Social Functioning : Visit 5	87.5 Average Score
Short Form (SF)-36 Health Survey Pt #8: Physical Functioning : Visit 5	75 Average Score
Short Form (SF)-36 Health Survey Pt #8 Role-physcial : Visit 9	100 Average Score
Short Form (SF)-36 Health Survey Pt #8 Role-physcial : Visit 10	100 Average Score
Short Form (SF)-36 Health Survey Pt #8: Role-emotional : Visit 8	50 Average Score
Short Form (SF)-36 Health Survey Pt #8: Energy/fatigue : Visit 1	40 Average Score
Short Form (SF)-36 Health Survey Pt #8: Energy/fatigue : Visit 5	50 Average Score
Short Form (SF)-36 Health Survey Pt #8: Energy/fatigue : Visit 8	50 Average Score
Short Form (SF)-36 Health Survey Pt #8: Energy/fatigue : Visit 9	45 Average Score
Short Form (SF)-36 Health Survey Pt #8 : Emotional Well-being : Visit 1	52 Average Score
Short Form (SF)-36 Health Survey Pt #8: Social Functioning : Visit 5	50 Average Score
Short Form (SF)-36 Health Survey Pt #8 Pain : Visit 9	80 Average Score
Short Form (SF)-36 Health Survey Pt #8: General Health : Visit 9	80 Average Score
Short Form (SF)-36 Health Survey Pt #9: Role-physical : Visit 1	0 Average Score
Short Form (SF)-36 Health Survey Pt #9: Role-emotional : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #9: Role-emotional : Visit 8	100 Average Score
Short Form (SF)-36 Health Survey Pt #9: Role-emotional : Visit 9	100 Average Score
Short Form (SF)-36 Health Survey Pt #9: Energy/fatigue : Visit 9	70 Average Score
Short Form (SF)-36 Health Survey Pt #9: Energy/fatigue : Visit 10	75 Average Score
Short Form (SF)-36 Health Survey Pt #9: Emotional Well-being : Visit 1	84 Average Score
Short Form (SF)-36 Health Survey Pt #9: Social Functioning : Visit 8	62.5 Average Score
Short Form (SF)-36 Health Survey Pt #9: Pain : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #9: Pain : Visit 9	77.5 Average Score
Short Form (SF)-36 Health Survey Pt #9: General Health : Visit 10	56.25 Average Score
Short Form (SF)-36 Health Survey Pt #10: Physical Functioning : Visit 9	85 Average Score
Short Form (SF)-36 Health Survey Pt #10: Role-physical : Visit 8	100 Average Score
Short Form (SF)-36 Health Survey Pt #01 Physical Functioning : Visit 1	30 Average Score
Short Form (SF)-36 Health Survey Pt #01 Physical Functioning : Visit 5	55 Average Score
Short Form (SF)-36 Health Survey Pt #01 Physical Functioning : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #01 Physical Functioning : Visit 9	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #01 Physical Functioning : Visit 10	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #01 Role-emotional : Visit 10	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #01 Social Functioning : Visit 1	87.5 Average Score
Short Form (SF)-36 Health Survey Pt #01 Social Functioning : Visit 9	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #01 Pain : Visit 9	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #2 General Health : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #2 General Health : Visit 8	35 Average Score
Short Form (SF)-36 Health Survey Pt #2 General Health : Visit 9	31.25 Average Score
Short Form (SF)-36 Health Survey Pt #01 General Health : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #2 General Health : Visit 10	30 Average Score
Short Form (SF)-36 Health Survey Pt #3 Physical Functioning : Visit 1	16.67 Average Score
Short Form (SF)-36 Health Survey Pt #3 Physical Functioning : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #2 Physical Functioning : Visit 9	30 Average Score
Short Form (SF)-36 Health Survey Pt #2 Role-physical : Visit 9	0 Average Score
Short Form (SF)-36 Health Survey Pt #2 Role-physical : Visit 10	100 Average Score
Short Form (SF)-36 Health Survey Pt #2 Role-emotional : Visit 1	0 Average Score
Short Form (SF)-36 Health Survey Pt #2 Role-emotional : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #2 Role-emotional : Visit 9	100 Average Score
Short Form (SF)-36 Health Survey Pt #2 Role-emotional : Visit 10	100 Average Score
Short Form (SF)-36 Health Survey Pt #2 Energy/fatigue : Visit 1	25 Average Score
Short Form (SF)-36 Health Survey Pt #2 Energy/fatigue : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #2 Energy/fatigue : Visit 8	40 Average Score
Short Form (SF)-36 Health Survey Pt #2 Energy/fatigue : Visit 10	55 Average Score
Short Form (SF)-36 Health Survey Pt #2 Emotional Well-being : Visit 1	84 Average Score
Short Form (SF)-36 Health Survey Pt #2 Emotional Well-being : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #2 Emotional Well-being : Visit 8	88 Average Score
Short Form (SF)-36 Health Survey Pt #2 Emotional Well-being : Visit 9	92 Average Score
Short Form (SF)-36 Health Survey Pt #2 Emotional Well-being : Visit 10	76 Average Score
Short Form (SF)-36 Health Survey Pt #2 Social Functioning : Visit 1	87.5 Average Score
Short Form (SF)-36 Health Survey Pt #2 Social Functioning : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #2 Social Functioning : Visit 8	87.5 Average Score
Short Form (SF)-36 Health Survey Pt #2 Social Functioning : Visit 9	87.5 Average Score
Short Form (SF)-36 Health Survey Pt #2 Social Functioning : Visit 10	87.5 Average Score
Short Form (SF)-36 Health Survey Pt #2 Pain : Visit 1	32.5 Average Score
Short Form (SF)-36 Health Survey Pt #2 Pain : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #2 Pain : Visit 8	45 Average Score
Short Form (SF)-36 Health Survey Pt #2 Pain : Visit 9	45 Average Score
Short Form (SF)-36 Health Survey Pt #2 Pain : Visit 10	45 Average Score
Short Form (SF)-36 Health Survey Pt #2 General Health : Visit 1	25 Average Score
Short Form (SF)-36 Health Survey Pt #3 Physical Functioning : Visit 8	30 Average Score
Short Form (SF)-36 Health Survey Pt #3 Physical Functioning : Visit 9	40 Average Score
Short Form (SF)-36 Health Survey Pt #3 Physical Functioning : Visit 10	30 Average Score
Short Form (SF)-36 Health Survey Pt #3: Role-physical : Visit 1	25 Average Score
Short Form (SF)-36 Health Survey Pt #3: Role-physical : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #3: Role-physical : Visit 9	0 Average Score
Short Form (SF)-36 Health Survey Pt #3: Role-physical : Visit 10	0 Average Score
Short Form (SF)-36 Health Survey Pt #3: Role-emotional : Visit 1	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #3: Role-emotional : Visit 8	100 Average Score
Short Form (SF)-36 Health Survey Pt #3: Role-emotional : Visit 9	100 Average Score
Short Form (SF)-36 Health Survey Pt #3: Energy/fatigue : Visit 1	20 Average Score
Short Form (SF)-36 Health Survey Pt #3: Energy/fatigue : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #3: Energy/fatigue : Visit 8	5 Average Score
Short Form (SF)-36 Health Survey Pt #3: Energy/fatigue : Visit 9	5 Average Score
Short Form (SF)-36 Health Survey Pt #3: Energy/fatigue : Visit 10	5 Average Score
Short Form (SF)-36 Health Survey Pt #3: Emotional Well-being : Visit 1	88 Average Score
Short Form (SF)-36 Health Survey Pt #3: Emotional Well-being : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #3: Emotional Well-being : Visit 8	68 Average Score
Short Form (SF)-36 Health Survey Pt #3: Emotional Well-being : Visit 9	68 Average Score
Short Form (SF)-36 Health Survey Pt #3: Emotional Well-being : Visit 10	72 Average Score
Short Form (SF)-36 Health Survey Pt #01 Role-physical : Visit 1	0 Average Score
Short Form (SF)-36 Health Survey Pt #01 Role-physical : Visit 5	25 Average Score
Short Form (SF)-36 Health Survey Pt #01 Role-physical : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #01 Role-physical : Visit 9	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #01 Role-physical : Visit 10	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #01 Role-emotional : Visit 1	100 Average Score
Short Form (SF)-36 Health Survey Pt #01 Role-emotional : Visit 5	66.67 Average Score
Short Form (SF)-36 Health Survey Pt #01 Role-emotional : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #01 Role-emotional : Visit 9	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #01 Energy/fatigue : Visit 1	50 Average Score
Short Form (SF)-36 Health Survey Pt #01 Energy/fatigue : Visit 5	35 Average Score
Short Form (SF)-36 Health Survey Pt #01 Energy/fatigue : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #01 Energy/fatigue : Visit 9	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #01 Energy/fatigue : Visit 10	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #01 Emotional Well-being : Visit 1	88 Average Score
Short Form (SF)-36 Health Survey Pt #01 Emotional Well-being : Visit 5	84 Average Score
Short Form (SF)-36 Health Survey Pt #01 Emotional Well-being : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #01 Emotional Well-being : Visit 9	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #01 Emotional Well-being : Visit 10	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #01 Social Functioning : Visit 5	75 Average Score
Short Form (SF)-36 Health Survey Pt #01 Social Functioning : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #01 Social Functioning : Visit 10	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #01 Pain : Visit 1	100 Average Score
Short Form (SF)-36 Health Survey Pt #01 Pain : Visit 5	55 Average Score
Short Form (SF)-36 Health Survey Pt #01 Pain : Visit 8	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #01 Pain : Visit 10	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #01 General Health : Visit 1	65 Average Score
Short Form (SF)-36 Health Survey Pt #01 General Health : Visit 5	55 Average Score
Short Form (SF)-36 Health Survey Pt #01 General Health : Visit 9	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #01 General Health : Visit 10	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #2 Physical Functioning : Visit 1	30 Average Score
Short Form (SF)-36 Health Survey Pt #2 Physical Functioning : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #2 Physical Functioning : Visit 8	30 Average Score
Short Form (SF)-36 Health Survey Pt #2 Physical Functioning : Visit 10	75 Average Score
Short Form (SF)-36 Health Survey Pt #2 Role-physical : Visit 1	0 Average Score
Short Form (SF)-36 Health Survey Pt #2 Role-physical : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #2 Role-physical : Visit 8	0 Average Score
Short Form (SF)-36 Health Survey Pt #2 Role-emotional : Visit 8	100 Average Score
Short Form (SF)-36 Health Survey Pt #2 Energy/fatigue : Visit 9	20 Average Score
Short Form (SF)-36 Health Survey Pt #3: Role-physical : Visit 8	0 Average Score
Short Form (SF)-36 Health Survey Pt #3: Role-emotional : Visit 5	NA Average Score Data not collected
Short Form (SF)-36 Health Survey Pt #3: Role-emotional : Visit 10	100 Average Score
Short Form (SF)-36 Health Survey Pt #3 : Social Functioning : Visit 1	75 Average Score

Adverse Events

Bortezomib

Serious events: 3 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Measure	Bortezomib n=17 participants at risk Patients will receive 2 cycles of Bortezomib (given weekly for 4 weeks) for a total of 8 doses of Bortezomib. Each cycle will consist of weekly bortezomib with a 2 week interval between cycles. Bortezomib: Each patient will receive 2 cycles of Bortezomib. For each cycle Bortezomib will be given once a week, 1.3mg/m2 for 4 weeks with 2 weeks between each cycle.
Cardiac disorders Myocardial Infarction	5.9% 1/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Gastrointestinal disorders Dehydration	5.9% 1/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Infections and infestations Varicella aoster virus/systemic inflammatory response	5.9% 1/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Respiratory, thoracic and mediastinal disorders Hypoxia	5.9% 1/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.

Other adverse events

Measure	Bortezomib n=17 participants at risk Patients will receive 2 cycles of Bortezomib (given weekly for 4 weeks) for a total of 8 doses of Bortezomib. Each cycle will consist of weekly bortezomib with a 2 week interval between cycles. Bortezomib: Each patient will receive 2 cycles of Bortezomib. For each cycle Bortezomib will be given once a week, 1.3mg/m2 for 4 weeks with 2 weeks between each cycle.
Blood and lymphatic system disorders Hemoglobin	11.8% 2/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Blood and lymphatic system disorders Lymphopenia	41.2% 7/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	5.9% 1/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Blood and lymphatic system disorders Platelets	23.5% 4/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
General disorders Fatigue (asthenia, lethargy, malaise)	47.1% 8/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	17.6% 3/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
General disorders Insomnia	11.8% 2/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
General disorders Sweating (diaphoresis)	5.9% 1/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
General disorders Weight gain	5.9% 1/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
General disorders Weight loss	17.6% 3/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Skin and subcutaneous tissue disorders Bruising (in absence of Grade 3 or 4 thrombocytopenia)	5.9% 1/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other (Specify: skin lesion with some oozing)	5.9% 1/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Skin and subcutaneous tissue disorders Dry skin	5.9% 1/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Skin and subcutaneous tissue disorders Hyperpigmentation	5.9% 1/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Skin and subcutaneous tissue disorders Pruritus/itching	5.9% 1/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Skin and subcutaneous tissue disorders Rash/desquamation	5.9% 1/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Gastrointestinal disorders Anorexia	11.8% 2/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Gastrointestinal disorders Constipation	17.6% 3/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Gastrointestinal disorders Diarrhea	35.3% 6/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Gastrointestinal disorders Dry mouth/salivary gland (xerostomia)	5.9% 1/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Gastrointestinal disorders Nausea	35.3% 6/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Gastrointestinal disorders Vomiting	5.9% 1/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Infections and infestations Infection - Systemic Inflammatory Response Syndrome	5.9% 1/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Infections and infestations Infection - pulmonary/upper respiratory - upper airway NOS	11.8% 2/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils - Nose	5.9% 1/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils - Pharynx	5.9% 1/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis)	5.9% 1/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Infections and infestations Viral hepatitis	5.9% 1/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Blood and lymphatic system disorders Edema: limb	23.5% 4/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Metabolism and nutrition disorders ALT, SGPT (serum glutamic pyruvic transaminase)	5.9% 1/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Metabolism and nutrition disorders AST, SGOT(serum glutamic oxaloacetic transaminase)	17.6% 3/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	11.8% 2/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	17.6% 3/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Metabolism and nutrition disorders Creatinine	23.5% 4/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	76.5% 13/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Metabolism and nutrition disorders Glucose, serum-low (hypoglycemia)	5.9% 1/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Metabolism and nutrition disorders Magnesium, serum-low (hypomagnesemia)	17.6% 3/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Metabolism and nutrition disorders Phosphate, serum-low (hypophosphatemia)	11.8% 2/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Metabolism and nutrition disorders Potassium, serum-high (hyperkalemia)	5.9% 1/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	11.8% 2/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Metabolism and nutrition disorders Sodium, serum-high (hypernatremia)	5.9% 1/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	29.4% 5/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized	5.9% 1/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Nervous system disorders Confusion	5.9% 1/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Nervous system disorders Mood alteration - Anxiety	5.9% 1/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Nervous system disorders Mood alteration - Depression	5.9% 1/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Nervous system disorders Neuropathy: sensory	47.1% 8/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Nervous system disorders Syncope (fainting)	5.9% 1/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Eye disorders Dry eye syndrome	17.6% 3/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Eye disorders Ocular/Visual - Other (Specify, Meibomitis)	11.8% 2/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Eye disorders Vision-blurred vision	11.8% 2/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Gastrointestinal disorders Pain - Abdomen NOS	5.9% 1/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Musculoskeletal and connective tissue disorders Pain - Back	5.9% 1/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Nervous system disorders Pain - Head/headache	5.9% 1/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Musculoskeletal and connective tissue disorders Pain - Joint	5.9% 1/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Cardiac disorders Pain - Chest Wall	5.9% 1/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Respiratory, thoracic and mediastinal disorders Bronchospasm, wheezing	5.9% 1/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Respiratory, thoracic and mediastinal disorders Cough	47.1% 8/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	17.6% 3/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Respiratory, thoracic and mediastinal disorders Hypoxia	11.8% 2/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
Respiratory, thoracic and mediastinal disorders Nasal cavity/paranasal sinus reactions	5.9% 1/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.
General disorders Flu-like syndrome	17.6% 3/17 • Adverse events were collected for each patient during treatment and in follow up for up to 18 weeks.

Additional Information

Clinical Trials at Northwestern University

Northwestern University

Phone: 312-695-6180

Email: cancertrials@northwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place