EVOLVE: Evaluation of Outcomes for Quality of Life and Activities of Daily Living for BKP in the Treatment of VCFs

• Sponsor: Medtronic Spinal and Biologics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01871519
• Collaborator: (none)
• Enrollment: 354
• Locations: 25
• Arm: 1
• Duration (Months): 36
• Patients Per Site: 14.2
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The study objective is to collect and report 12-month outcomes pertaining to activities of daily living, quality of life, and safety parameters in a Medicare population to be treated with balloon kyphoplasty in the treatment of painful, acute, vertebral body compression fractures (VCFs) associated with either osteoporosis or cancer. The primary objective is to show statistically significant improvement from baseline in the four co-primary endpoints (SF-36v2, PCS, EQ-5D, NRS back pain and ODI) at 3-months; study success will be declared if the primary objective is met. New radiographic fractures, non-surgical management received, VCF-related healthcare resource utilization, and vertebral body height restoration data will also be collected.

Condition or Disease	Intervention/Treatment	Phase
Compression Fracture of Vertebral Body; Osteoporosis; Cancer	Device: Balloon kyphoplasty	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 354 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective and Multicenter Evaluation of Outcomes for Quality of Life and Activities of Daily Living for Balloon Kyphoplasty in the Treatment of Vertebral Compression Fractures
• Study Start Date: May 1, 2013
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: Balloon Kyphoplasty This group of patients will be treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.	Device: Balloon kyphoplasty; The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.; Other Names: BKP

Outcome Measures

Primary Outcome Measures

1. Back Pain Change From Baseline at 3 Months [Baseline, 3 months after surgery]

   Back pain was measured using NRS. Patients rated their back pain on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be."

2. Back Function Change From Baseline by Oswestry Disability Index at 3 Months [Baseline, 3 months after surgery]

   ODI Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).

3. SF-36v2 Physical Component Summary Change From Baseline at 3 Months [Baseline, 3 months after surgery]

   Quality of life was assessed by Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) version 2.0. The SF-36 v2 physical component summary (PCS) score is between 0 and 100, with higher scores denoting better quality of life.

4. Change From Baseline in Quality of Life by the EQ-5D Index at 3 Months [Baseline, 3 months after surgery]

   EQ-5D index scores range from 0 to 1.0 on a scale where 0 = death and 1.0 = perfect health.

Secondary Outcome Measures

1. Back Pain [Baseline, 7 days, 30 days, 6 months, 9 months, and 12 months]

   Back pain was measured using NRS. Patients rated their back pain on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be."

2. Back Function (ODI) [Baseline, 30 days, 6 months, and 12 months]

   ODI Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).

3. Quality of Life by SF-36v2 PCS [Baseline, 30 days, 6 months, and 12 months]

   Quality of life was assessed by Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) version 2.0. The SF-36 v2 physical component summary (PCS) score is between 0 and 100, with higher scores denoting better quality of life.

4. Quality of Life by EQ-5D Index Score [Baseline, 30 days, 6 months, and 12 months]

5. Percentage of Subjects Having Daily Living Activities Limited Due to Back Pain in the Previous 2 Weeks [Baseline, 30 days, 3 months, 6 months, and 12 months]

6. The Number of Days With Limited Activities and Bed Rest Due to Back Pain in the Previous 2 Weeks; [Baseline, 30 days, 3 months, 6 months, and 12 months]

7. Ambulatory Status [Baseline, 7 days, 30 days, 3 months, 6 months, 9 months, and 12 months]

8. Barthel Index (Only for Subjects With Osteoporosis) [Baseline, 30 days, 3 months 6 months, and 12 months]

   For subjects with osteoporosis, the Barthel index was used for rating subject activities of daily living on a scale from 0 (maximum disability) to 20 (no disability).

9. Karnofsky Performance Scale [Baseline, 30 days, 3 months 6 months, and 12 months]

   For subjects with cancer, the Karnofsky performance scale was used for rating subject activities of daily living.The Karnofsky performance scale rates a subject on an 11-step scale from 0 (dead) to 100 (normal, no complaints, no evidence of disease), and a score of 70 is a clinically meaningful threshold for self-care.

10. Vertebral Body Height Restoration (Absolute Height Restored as Percent, AHRP) [Baseline, pre-discharge, 3 months, and 12 months]

    AHRP (Absolute height restored as percent) was the amount of height restored in the vertebral body expressed as a percent of estimated pre-fracture (EP) height. Measurements were assessed at anterior, medial, and posterior locations on the vertebral body.

11. Vertebral Body Angle [Baseline, pre-discharge, 3 months, and 12 months]

    The vertebral body kyphosis angle (VBA) was defined as the angle formed by lines drawn parallel to the caudal and cranial fractured vertebral body endplates.

12. Local Cobb Angle [Baseline, pre-discharge, 3 months, and 12 months]

    The local Cobb angle (LCA) was defined as the angle formed by lines drawn parallel to the superior endplate of the vertebral body above and the inferior endplate of the vertebral body below.

13. Subsequent Radiographic Fractures [3 months and 12 months]

    A subsequent VCF was defined as any fracture at an index or non-index vertebral body occurring after the initial procedure as compared to baseline. The percentage of subjects having one or more subsequent VCFs is presented.

14. Neurological Success Rate [Pre-discharge, 30 days, 3 months, 6 months, and 12 months]

    Neurological functions were assessed preoperatively and postoperatively. Each of the individual functions was comprised of a number of elements. Investigators evaluated whether observations in each function category was normal or abnormal, and documentation of abnormal findings were required for each element in that function. Success for each component was defined as maintenance or improvement from preoperative for all elements. Success for overall neurologic status was defined as successful in all components.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Identified as an appropriate candidate for BKP and should have made the choice to have the procedure.

2. Must be Medicare Eligible (At least 65 years of age or otherwise eligible).

3. Must have one to three target VCFs, located between T5 and L5, which are due to underlying primary or secondary osteoporosis or cancer.

4. Cancer patients should not have had a change in chemotherapy regimen within the last month, nor should they have a planned change within the next month from time of enrollment, with the exception of changes in dose.

5. All VCFs to be treated must have clinical pain symptoms (pain on palpation/percussion over the fractured vertebral body) that correlate with radiographic findings as follows:

6. Height change: An acute (≤ four month) change in VB height or morphology from a previous x-ray, CT or MRI, with height loss at the anterior, middle or posterior portion of the VB consistent with a worsening of one or more grades by the Genant criteria20, OR

7. Positive MRI or bone scan: VB shows hyperintense signal on STIR sequence MRI, or target VB is positive on radionuclide bone scan.

8. All VCFs to be treated must have an estimated fracture age of four months or less.

9. Treatment of all target VCFs must be technically feasible and clinically appropriate for balloon kyphoplasty.

10. Pre-treatment back pain by numerical rating scale (NRS) score must be ≥ 7 (0-10 scale) and refractory to non-surgical management.

11. Pre-treatment Oswestry Disability Index must be ≥30 (0 - 100 scale).

12. Must have life expectancy of ≥ 12 months.

13. Must declare availability for all study visits.

14. Must be able to understand the risks and benefits of participating in the study and be willing to provide written informed consent.

15. Must have the mental capacity necessary to comply with protocol requirements for the 12- month duration of study.

Exclusion Criteria:

1. Vertebral body morphology or fracture configuration contraindicative of balloon kyphoplasty.

2. VCFs due to high-energy trauma.

3. Asymptomatic VCFs or prophylactic treatment of non-fractured vertebral bodies.

4. VCFs accompanied at the same site by primary tumors of the bone (e.g., osteosarcoma), solitary plasmacytoma or osteoblastic tumors.

5. Platelet count of <20,000/uL as measured at the time of hospital admission for the procedure.

6. Back pain due to causes other than acute fracture.

7. VCF with a clinically estimated (based on radiographic evidence as well as patient history) age of fracture > four months.

8. VCF accompanied by objective evidence of secondary radiculopathy or neurologic compromise.

9. VCFs with the need for spinal surgery beyond balloon kyphoplasty.

10. Spinal cord compression or canal compromise requiring decompression.

11. Significant clinical comorbidity that may either contra-indicate surgery or interfere with long-term data collection or follow-up.

12. Pre-existing conditions contrary to balloon kyphoplasty such as:

13. Allergy to any components (e.g., bone cement, contrast medium) of the balloon kyphoplasty device/procedure.

14. Active or incompletely treated infection of the vertebral column or active systemic infection, including unresolved urinary tract infection.

15. Irreversible coagulopathy or bleeding disorder.

16. Contraindications to both MRI and radionuclide bone scan.

17. Concurrent participation in another clinical study.

18. Pregnant or intending to become pregnant during the course of the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alabama Clinical Therapeutics, LLC	Birmingham	Alabama	United States	35235
2	University of Alabama at Birmingham, Division of Neurological Surgery	Birmingham	Alabama	United States	35294
3	Washington Radiologist Medical Group	Fremont	California	United States	94538
4	Sutter Health Sacramento Sierra Region	Sacramento	California	United States	95816
5	Alta Orthopaedic Medical Group	Santa Barbara	California	United States	93101
6	Torrance Memorial Medical Center	Torrance	California	United States	90505
7	Radiology Imaging Specialist of Lakeland	Lakeland	Florida	United States	33805
8	The Back Center	Melbourne	Florida	United States	32901
9	Physicians & Surgeons of Pocatello	Blackfoot	Idaho	United States	83221
10	St. Luke's Health System	Boise	Idaho	United States	83712
11	Central Illinois Neuroscience Foundation	Bloomington	Illinois	United States	61701
12	Adventist Health Partners	Hinsdale	Illinois	United States	60521
13	Presence Saint Joseph Medical Center	Joliet	Illinois	United States	60435
14	Illinois Bone & Joint	Morton Grove	Illinois	United States	60053
15	Indiana Spine Group	Carmel	Indiana	United States	46032
16	Advanced Diagnostic Imaging, PC	Saginaw	Michigan	United States	48603
17	Beaumont Health System	Troy	Michigan	United States	48085
18	Premier Radiology	Tupelo	Mississippi	United States	38802
19	Sierra Regional Spine Institute	Reno	Nevada	United States	89509
20	Consulting Orthopaedic Associates, Inc	Sylvania	Ohio	United States	43560
21	Clinical Investigations, LLC	Edmond	Oklahoma	United States	73013
22	James R. Webb, P.C.	Tulsa	Oklahoma	United States	74133
23	NeuroSpine Institute, LLC	Eugene	Oregon	United States	97401
24	Scoliosis & Spine Surgery Clinic of Memphis, PLLC	Memphis	Tennessee	United States	38119
25	The West Clinic	Memphis	Tennessee	United States	38120

Sponsors and Collaborators

• Medtronic Spinal and Biologics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic Spinal and Biologics
• ClinicalTrials.gov Identifier: NCT01871519
• Other Study ID Numbers: P12-03
• First Posted: Jun 6, 2013
• Last Update Posted: Mar 29, 2017
• Last Verified: Feb 1, 2017

• Keywords provided by Medtronic Spinal and Biologics: vertebral body compression fracture
• Additional relevant MeSH terms: Osteoporosis; Fractures, Bone; Fractures, Compression

Study Results

Participant Flow

Recruitment Details	A total of 354 subjects were enrolled in this study. Among them, 350 subjects had BKP surgery and 4 subjects were not treated with BKP. Two of the non-treated subjects voluntarily withdrew from the study and 2 subjects were lost-to-follow-up before surgery.

Arm/Group Title	Balloon Kyphoplasty
Arm/Group Description	This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.
Period Title: Overall Study
STARTED	350
COMPLETED	260
NOT COMPLETED	90

Baseline Characteristics

Arm/Group Title	Balloon Kyphoplasty
Arm/Group Description	This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.
Overall Participants	350
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	78.9 (8.1)
Sex: Female, Male (Count of Participants)
Female	272 77.7%
Male	78 22.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	6 1.7%
Not Hispanic or Latino	344 98.3%
Unknown or Not Reported	0 0%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaska Native	1 0.3%
Asian	12 3.4%
Black or African American	4 1.1%
Native Hawaiian or other pacific islander	0 0%
White	330 94.3%
Other	3 0.9%
Height (inches) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [inches]	64.3 (3.9)
Weight (lbs) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [lbs]	153.9 (36.9)
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	26.1 (5.5)
Estimated pre-fracture vertebral body height (mm) [Mean (Standard Deviation) ]
Anterior	24.940 (4.811)
Middle	24.207 (4.264)
Posterior	26.502 (4.397)

Outcome Measures

1. Primary Outcome

Title	Back Pain Change From Baseline at 3 Months
Description	Back pain was measured using NRS. Patients rated their back pain on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be."
Time Frame	Baseline, 3 months after surgery

Outcome Measure Data

Analysis Population Description

The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.

Arm/Group Title	Balloon Kyphoplasty
Arm/Group Description	This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.
Measure Participants	350
Back pain at baseline	8.7 (1.2)
Back pain at 3 Months	2.7 (2.7)
Back pain change	-6.0 (3.0)

2. Primary Outcome

Title	Back Function Change From Baseline by Oswestry Disability Index at 3 Months
Description	ODI Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).
Time Frame	Baseline, 3 months after surgery

Outcome Measure Data

Analysis Population Description

The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.

Arm/Group Title	Balloon Kyphoplasty
Arm/Group Description	This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.
Measure Participants	350
ODI score at baseline	63.4 (14.9)
ODI score at 3 months	27.1 (18.8)
ODI change	-35.3 (20.5)

3. Primary Outcome

Title	SF-36v2 Physical Component Summary Change From Baseline at 3 Months
Description	Quality of life was assessed by Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) version 2.0. The SF-36 v2 physical component summary (PCS) score is between 0 and 100, with higher scores denoting better quality of life.
Time Frame	Baseline, 3 months after surgery

Outcome Measure Data

Analysis Population Description

The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.

Arm/Group Title	Balloon Kyphoplasty
Arm/Group Description	This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.
Measure Participants	346
SF-36 PCS at baseline	24.2 (7.0)
SF-36 PCS at 3 months	36.6 (11.2)
SF-36 PCS change	12.4 (11.4)

4. Primary Outcome

Title	Change From Baseline in Quality of Life by the EQ-5D Index at 3 Months
Description	EQ-5D index scores range from 0 to 1.0 on a scale where 0 = death and 1.0 = perfect health.
Time Frame	Baseline, 3 months after surgery

Outcome Measure Data

Analysis Population Description

The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.

Arm/Group Title	Balloon Kyphoplasty
Arm/Group Description	This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.
Measure Participants	348
EQ-5D index at baseline	0.383 (0.212)
EQ-5D index at 3 months	0.746 (0.194)
EQ-5D index score change	0.351 (0.267)

5. Secondary Outcome

Title	Back Pain
Description	Back pain was measured using NRS. Patients rated their back pain on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be."
Time Frame	Baseline, 7 days, 30 days, 6 months, 9 months, and 12 months

Outcome Measure Data

Analysis Population Description

The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.

Arm/Group Title	Balloon Kyphoplasty
Arm/Group Description	This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.
Measure Participants	350
Back pain at baseline	8.7 (1.2)
Back pain at 7 days	3.4 (2.3)
Back pain at 30 days	3.2 (2.7)
Back pain at 6 months	2.5 (2.7)
Back pain at 9 months	2.3 (2.6)
Back pain at 12 months	2.4 (2.8)

6. Secondary Outcome

Title	Back Function (ODI)
Description	ODI Questionnaire was used to assess patient back function. The ODI score ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).
Time Frame	Baseline, 30 days, 6 months, and 12 months

Outcome Measure Data

Analysis Population Description

The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.

Arm/Group Title	Balloon Kyphoplasty
Arm/Group Description	This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.
Measure Participants	350
ODI score at baseline	63.4 (14.9)
ODI score at 30 days	32.5 (19.5)
ODI score at 6 months	25.7 (19.0)
ODI score at 12 months	25.8 (19.0)

7. Secondary Outcome

Title	Quality of Life by SF-36v2 PCS
Description	Quality of life was assessed by Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) version 2.0. The SF-36 v2 physical component summary (PCS) score is between 0 and 100, with higher scores denoting better quality of life.
Time Frame	Baseline, 30 days, 6 months, and 12 months

Outcome Measure Data

Analysis Population Description

The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.

Arm/Group Title	Balloon Kyphoplasty
Arm/Group Description	This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.
Measure Participants	346
SF-36 PCS at baseline	24.2 (7.0)
SF-36 PCS at 30 days	34.9 (9.8)
SF-36 PCS at 6 months	37.6 (11.5)
SF-36 PCS at 12 months	38.2 (12.1)

8. Secondary Outcome

Title	Quality of Life by EQ-5D Index Score
Time Frame	Baseline, 30 days, 6 months, and 12 months

Outcome Measure Data

Analysis Population Description

The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.

Arm/Group Title	Balloon Kyphoplasty
Arm/Group Description	This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.
Measure Participants	348
EQ-5D index at baseline	0.383 (0.212)
EQ-5D index at 30 days	0.710 (0.196)
EQ-5D index at 6 months	0.756 (0.193)
EQ-5D index at 12 months	0.758 (0.193)

9. Secondary Outcome

Title	Percentage of Subjects Having Daily Living Activities Limited Due to Back Pain in the Previous 2 Weeks
Time Frame	Baseline, 30 days, 3 months, 6 months, and 12 months

Outcome Measure Data

Analysis Population Description

The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.

Arm/Group Title	Balloon Kyphoplasty
Arm/Group Description	This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.
Measure Participants	350
Baseline	96.3 27.5%
30 days	53.3 15.2%
3 months	31.8 9.1%
6 months	31.0 8.9%
12 months	28.9 8.3%

10. Secondary Outcome

Title	The Number of Days With Limited Activities and Bed Rest Due to Back Pain in the Previous 2 Weeks;
Time Frame	Baseline, 30 days, 3 months, 6 months, and 12 months

Outcome Measure Data

Analysis Population Description

The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.

Arm/Group Title	Balloon Kyphoplasty
Arm/Group Description	This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.
Measure Participants	350
days of limited activities at baseline	11.0 (4.6)
days of bed rest at baseline	6.0 (5.9)
days of limited activities at 30 days	4.7 (5.7)
days of bed rest at 30 days	1.5 (3.5)
days of limited activities at 3 months	2.6 (4.6)
days of bed rest at 3 months	0.7 (2.3)
days of limited activities at 6 months	2.6 (4.8)
days of bed rest at 6 months	0.7 (2.5)
days of limited activities at 12 months	2.2 (4.5)
days of bed rest at 12 months	0.7 (2.4)

11. Secondary Outcome

Title	Ambulatory Status
Time Frame	Baseline, 7 days, 30 days, 3 months, 6 months, 9 months, and 12 months

Outcome Measure Data

Analysis Population Description

The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.

Arm/Group Title	Balloon Kyphoplasty
Arm/Group Description	This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices
Measure Participants	350
Able to walk at baseline	42.3 12.1%
Walk with aid at baseline	50.3 14.4%
Unable to walk at baseline	7.4 2.1%
Able to walk at 7 days	59.9 17.1%
Walk with aid at 7 days	38.3 10.9%
Unable to walk at 7 days	1.8 0.5%
Able to walk at 30 days	62.5 17.9%
Walk with aid at 30 days	36.2 10.3%
Unable to walk at 30 days	1.3 0.4%
Able to walk at 3 months	64.5 18.4%
Walk with aid at 3 months	34.1 9.7%
Unable to walk at 3 months	1.4 0.4%
Able to walk at 6 months	62.4 17.8%
Walk with aid at 6 months	36.1 10.3%
Unable to walk at 6 months	1.5 0.4%
Able to walk at 9 months	68.7 19.6%
Walk with aid at 9 months	30.9 8.8%
Unable to walk at 9 months	0.4 0.1%
Able to walk at 12 months	63.2 18.1%
Walk with aid at 12months	35.7 10.2%
Unable to walk at 12 months	1.2 0.3%

12. Secondary Outcome

Title	Barthel Index (Only for Subjects With Osteoporosis)
Description	For subjects with osteoporosis, the Barthel index was used for rating subject activities of daily living on a scale from 0 (maximum disability) to 20 (no disability).
Time Frame	Baseline, 30 days, 3 months 6 months, and 12 months

Outcome Measure Data

Analysis Population Description

The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.

Arm/Group Title	Balloon Kyphoplasty
Arm/Group Description	This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.
Measure Participants	343
Barthel index score at baseline	16.2 (4.0)
Barthel index score at 30 days	18.8 (2.1)
Barthel index score at 3 months	19.1 (2.0)
Barthel index score at 6 months	19.1 (1.8)
Barthel index score at 12 months	19.1 (1.8)

13. Secondary Outcome

Title	Karnofsky Performance Scale
Description	For subjects with cancer, the Karnofsky performance scale was used for rating subject activities of daily living.The Karnofsky performance scale rates a subject on an 11-step scale from 0 (dead) to 100 (normal, no complaints, no evidence of disease), and a score of 70 is a clinically meaningful threshold for self-care.
Time Frame	Baseline, 30 days, 3 months 6 months, and 12 months

Outcome Measure Data

Analysis Population Description

The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.

Arm/Group Title	Balloon Kyphoplasty
Arm/Group Description	This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.
Measure Participants	7
Karnofsky performance scale at baseline	75.7 (21.5)
Karnofsky performance scale at 30 days	88.0 (11.0)
Karnofsky performance scale at 3 months	90.0 (14.1)
Karnofsky performance scale at 6 months	85.0 (30.0)
Karnofsky performance scale at 12 months	96.7 (5.8)

14. Secondary Outcome

Title	Vertebral Body Height Restoration (Absolute Height Restored as Percent, AHRP)
Description	AHRP (Absolute height restored as percent) was the amount of height restored in the vertebral body expressed as a percent of estimated pre-fracture (EP) height. Measurements were assessed at anterior, medial, and posterior locations on the vertebral body.
Time Frame	Baseline, pre-discharge, 3 months, and 12 months

Outcome Measure Data

Analysis Population Description

A total of 490 treated levels in 344 subjects were included in vertebral body height restoration analysis. The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.

Arm/Group Title	Balloon Kyphoplasty
Arm/Group Description	This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.
Measure Participants	344
Measure Treated levels	490
Anterior height Loss from EP at baseline	-26.438 (22.008)
Middle height loss from EP at baseline	-27.719 (20.861)
Posterior height loss from EP at baseline	-8.228 (10.966)
Anterior AHRP at pre-discharge	3.897 (9.822)
Middle AHRP at pre-discharge	4.205 (9.783)
Posterior AHRP at pre-discharge	1.280 (7.280)
Anterior AHRP at 3 months	1.511 (10.426)
Middle AHRP at 3 months	2.223 (10.076)
Posterior AHRP at 3 months	0.101 (7.474)
Anterior AHRP at 12 months	1.308 (10.765)
Middle AHRP at 12 months	1.567 (10.453)
Posterior AHRP at 12 months	-0.028 (8.284)

15. Secondary Outcome

Title	Vertebral Body Angle
Description	The vertebral body kyphosis angle (VBA) was defined as the angle formed by lines drawn parallel to the caudal and cranial fractured vertebral body endplates.
Time Frame	Baseline, pre-discharge, 3 months, and 12 months

Outcome Measure Data

Analysis Population Description

A total of 490 treated levels in 344 subjects were included in VBA analysis. The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.

Arm/Group Title	Balloon Kyphoplasty
Arm/Group Description	This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.
Measure Participants	344
Measure Treated levels	490
vertebral body angle at baseline	-10.474 (8.152)
Vertebral body angle at pre-discharge	-9.522 (6.867)
Angle change from baseline at pre-discharge	1.117 (4.137)
Vertebral body angle at 3 months	-10.119 (6.781)
Angle change from baseline at 3 months	0.633 (4.282)
Vertebral body angle at 12 months	-9.876 (6.714)
Angle change from baseline at 12 months	0.748 (4.315)

16. Secondary Outcome

Title	Local Cobb Angle
Description	The local Cobb angle (LCA) was defined as the angle formed by lines drawn parallel to the superior endplate of the vertebral body above and the inferior endplate of the vertebral body below.
Time Frame	Baseline, pre-discharge, 3 months, and 12 months

Outcome Measure Data

Analysis Population Description

A total of 490 treated levels in 344 subjects were included in LCA analysis. The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.

Arm/Group Title	Balloon Kyphoplasty
Arm/Group Description	This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.
Measure Participants	344
Measure Treated levels	490
Local Cobb angle at baseline	-12.919 (18.302)
Local Cobb angle at pre-discharge	-11.190 (17.244)
Angle change from baseline at pre-discharge	2.707 (5.102)
Local Cobb angle at 3 months	-13.439 (17.843)
Angle change from baseline at 3 months	0.253 (5.979)
Local Cobb angle at 12 months	-12.819 (18.643)
Angle change from baseline at 12 months	-0.197 (6.106)

17. Secondary Outcome

Title	Subsequent Radiographic Fractures
Description	A subsequent VCF was defined as any fracture at an index or non-index vertebral body occurring after the initial procedure as compared to baseline. The percentage of subjects having one or more subsequent VCFs is presented.
Time Frame	3 months and 12 months

Outcome Measure Data

Analysis Population Description

The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.

Arm/Group Title	Balloon Kyphoplasty
Arm/Group Description	This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.
Measure Participants	267
Subsequent fractures at 3 months	36.7 10.5%
Subsequent fractures at 12 months	47.6 13.6%

18. Secondary Outcome

Title	Neurological Success Rate
Description	Neurological functions were assessed preoperatively and postoperatively. Each of the individual functions was comprised of a number of elements. Investigators evaluated whether observations in each function category was normal or abnormal, and documentation of abnormal findings were required for each element in that function. Success for each component was defined as maintenance or improvement from preoperative for all elements. Success for overall neurologic status was defined as successful in all components.
Time Frame	Pre-discharge, 30 days, 3 months, 6 months, and 12 months

Outcome Measure Data

Analysis Population Description

The number analyzed was based on the observed data and there were missing data stemming mostly from subject drop-out or lost-to-follow-ups. To some extent missing data were from unanswered questions, missing image, etc.

Arm/Group Title	Balloon Kyphoplasty
Arm/Group Description	This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.
Measure Participants	350
Neurological success at predischarge	79.2 22.6%
Neurological success at 30 days	76.7 21.9%
Neurological success at 3 months	76.4 21.8%
Neurological success at 6 months	74.3 21.2%
Neurological success at 12 months	76.7 21.9%

Adverse Events

Time Frame	Overall study about 12-month follow up
Arm/Group Title	Balloon Kyphoplasty
Arm/Group Description	This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer. Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.
All Cause Mortality
	Balloon Kyphoplasty
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Balloon Kyphoplasty
	Affected / at Risk (%)	# Events
Total	79/350 (22.6%)
Cardiac disorders
Atrial fibrillation	1/350 (0.3%)	1
Cardiac arrest	2/350 (0.6%)	2
Cardiac failure congestive	1/350 (0.3%)	1
Cardio-respiratory arrest	1/350 (0.3%)	1
Coronary artery disease	1/350 (0.3%)	1
Myocardial infarction	1/350 (0.3%)	1
Tachycardia	1/350 (0.3%)	1
Eye disorders
Cataract	1/350 (0.3%)	1
Gastrointestinal disorders
Abdominal pain	1/350 (0.3%)	1
Colitis ulcerative	1/350 (0.3%)	1
Diverticulitis intestinal haemorrhagic	1/350 (0.3%)	1
Femoral hernia, obstructive	1/350 (0.3%)	1
Gastrointestinal haemorrhage	1/350 (0.3%)	1
Lower gastrointestinal haemorrhage	1/350 (0.3%)	1
Pancreatitis	1/350 (0.3%)	1
General disorders
General physical health deterioration	1/350 (0.3%)	1
Hepatobiliary disorders
Cholelithiasis	2/350 (0.6%)	2
Chronic hepatic failure	1/350 (0.3%)	1
Lupus hepatitis	1/350 (0.3%)	1
Infections and infestations
Cellulitis	1/350 (0.3%)	1
Pneumonia	3/350 (0.9%)	3
Urinary tract infection	1/350 (0.3%)	1
Injury, poisoning and procedural complications
Fall	3/350 (0.9%)	3
Femoral neck fracture	1/350 (0.3%)	1
Femur fracture	1/350 (0.3%)	1
Hip fracture	2/350 (0.6%)	2
Lower limb fracture	1/350 (0.3%)	1
Lumbar vertebral fracture	2/350 (0.6%)	3
Pelvic fracture	1/350 (0.3%)	1
Spinal compression fracture	11/350 (3.1%)	14
Spinal fracture	2/350 (0.6%)	2
Thoracic vertebral fracture	2/350 (0.6%)	2
Metabolism and nutrition disorders
Dehydration	1/350 (0.3%)	1
Musculoskeletal and connective tissue disorders
Arthritis	2/350 (0.6%)	2
Back pain	17/350 (4.9%)	26
Intervertebral disc degeneration	1/350 (0.3%)	1
Intervertebral disc protrusion	1/350 (0.3%)	1
Metatarsalgia	1/350 (0.3%)	1
Spinal pain	2/350 (0.6%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia	1/350 (0.3%)	1
Bladder cancer	1/350 (0.3%)	1
Malignant neoplasm progression	1/350 (0.3%)	1
Mesothelioma malignant	1/350 (0.3%)	1
Plasma cell myeloma	2/350 (0.6%)	2
Nervous system disorders
Cerebrovascular accident	1/350 (0.3%)	1
Hydrocephalus	1/350 (0.3%)	1
Sciatica	1/350 (0.3%)	1
Transient ischaemic attack	2/350 (0.6%)	2
Renal and urinary disorders
Haematuria	1/350 (0.3%)	1
Renal failure	1/350 (0.3%)	1
Renal failure chronic	1/350 (0.3%)	1
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	1/350 (0.3%)	1
Aspiration	1/350 (0.3%)	1
Asthma	1/350 (0.3%)	1
Chronic obstructive pulmonary disease	5/350 (1.4%)	7
Pneumonia aspiration	1/350 (0.3%)	1
Pneumothorax	1/350 (0.3%)	1
Respiratory arrest	1/350 (0.3%)	1
Respiratory failure	4/350 (1.1%)	4
Vascular disorders
Vascular stenosis	1/350 (0.3%)	1
Other (Not Including Serious) Adverse Events
	Balloon Kyphoplasty
	Affected / at Risk (%)	# Events
Total	128/350 (36.6%)
Blood and lymphatic system disorders
Iron deficiency anaemia	1/350 (0.3%)	1
Cardiac disorders
Atrial fibrillation	2/350 (0.6%)	2
Atrioventricular block	1/350 (0.3%)	1
Cardiac failure congestive	1/350 (0.3%)	1
Supraventricular tachycardia	1/350 (0.3%)	1
Tachyarrhythmia	1/350 (0.3%)	1
Ear and labyrinth disorders
Vertigo	2/350 (0.6%)	2
Gastrointestinal disorders
Abdominal hernia	1/350 (0.3%)	1
Abdominal pain lower	1/350 (0.3%)	1
Abdominal pain upper	2/350 (0.6%)	2
Coeliac disease	1/350 (0.3%)	1
Constipation	1/350 (0.3%)	1
Diarrhoea	1/350 (0.3%)	1
Faecal incontinence	1/350 (0.3%)	1
Inguinal hernia	1/350 (0.3%)	1
General disorders
Death	1/350 (0.3%)	1
Device breakage	1/350 (0.3%)	1
Device malfunction	1/350 (0.3%)	1
Implant site extravasation	1/350 (0.3%)	1
Oedema peripheral	1/350 (0.3%)	1
Pain	1/350 (0.3%)	1
Hepatobiliary disorders
Cholelithiasis	1/350 (0.3%)	1
Infections and infestations
Bronchitis	2/350 (0.6%)	2
Cystitis	1/350 (0.3%)	1
Herpes zoster	2/350 (0.6%)	2
Kidney infection	1/350 (0.3%)	1
Pneumonia	2/350 (0.6%)	2
Upper respiratory tract infection	1/350 (0.3%)	1
Urinary tract infection	1/350 (0.3%)	1
Injury, poisoning and procedural complications
Compression fracture	1/350 (0.3%)	1
Contusion	2/350 (0.6%)	2
Fall	9/350 (2.6%)	9
Hip fracture	1/350 (0.3%)	1
Humerus fracture	1/350 (0.3%)	1
Incision site haemorrhage	1/350 (0.3%)	1
Laceration	2/350 (0.6%)	2
Ligament sprain	1/350 (0.3%)	1
Lumbar vertebral fracture	2/350 (0.6%)	2
Muscle strain	2/350 (0.6%)	2
Radius fracture	1/350 (0.3%)	1
Rib fracture	4/350 (1.1%)	4
Road traffic accident	1/350 (0.3%)	1
Spinal compression fracture	18/350 (5.1%)	18
Spinal fracture	1/350 (0.3%)	1
Thoracic vertebral fracture	4/350 (1.1%)	4
Upper limb fracture	1/350 (0.3%)	1
Wound dehiscence	1/350 (0.3%)	1
Metabolism and nutrition disorders
Dehydration	1/350 (0.3%)	1
Hyponatraemia	1/350 (0.3%)	1
Musculoskeletal and connective tissue disorders
Arthralgia	8/350 (2.3%)	8
Arthritis	11/350 (3.1%)	11
Back pain	27/350 (7.7%)	30
Bone pain	1/350 (0.3%)	1
Bursitis	4/350 (1.1%)	5
Cervical spinal stenosis	1/350 (0.3%)	1
Costochondritis	1/350 (0.3%)	1
Facet joint syndrome	2/350 (0.6%)	2
Fracture nonunion	1/350 (0.3%)	1
Intervertebral disc disorder	1/350 (0.3%)	1
Kyphosis	10/350 (2.9%)	10
Lumbar spinal stenosis	1/350 (0.3%)	1
Musculoskeletal chest pain	3/350 (0.9%)	3
Musculoskeletal discomfort	1/350 (0.3%)	1
Musculoskeletal pain	3/350 (0.9%)	3
Myofascial pain syndrome	1/350 (0.3%)	1
Neck pain	3/350 (0.9%)	3
Osteoarthritis	1/350 (0.3%)	1
Osteoporosis	1/350 (0.3%)	1
Pain in extremity	3/350 (0.9%)	3
Pathological fracture	1/350 (0.3%)	1
Sacroiliitis	6/350 (1.7%)	6
Scoliosis	4/350 (1.1%)	4
Spinal column stenosis	1/350 (0.3%)	1
Spinal deformity	1/350 (0.3%)	1
Spinal osteoarthritis	2/350 (0.6%)	2
Spinal pain	2/350 (0.6%)	2
Spondylolisthesis	4/350 (1.1%)	4
Tendonitis	1/350 (0.3%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant	1/350 (0.3%)	1
Metastatic pain	1/350 (0.3%)	1
Nervous system disorders
Balance disorder	2/350 (0.6%)	2
Carpal tunnel syndrome	1/350 (0.3%)	1
Cerebrovascular accident	1/350 (0.3%)	1
Convulsion	1/350 (0.3%)	1
Dizziness	3/350 (0.9%)	3
Haemorrhage intracranial	1/350 (0.3%)	1
Headache	2/350 (0.6%)	2
Hypoaesthesia	1/350 (0.3%)	1
Neuropathy peripheral	1/350 (0.3%)	1
Radiculitis	1/350 (0.3%)	1
Radiculopathy	2/350 (0.6%)	2
Spinal cord compression	1/350 (0.3%)	1
Syncope	1/350 (0.3%)	1
Transient ischaemic attack	1/350 (0.3%)	1
Unresponsive to stimuli	1/350 (0.3%)	1
Psychiatric disorders
Insomnia	1/350 (0.3%)	1
Mental status changes	1/350 (0.3%)	1
Renal and urinary disorders
Renal failure	1/350 (0.3%)	1
Urinary incontinence	1/350 (0.3%)	1
Reproductive system and breast disorders
Pelvic pain	1/350 (0.3%)	1
Respiratory, thoracic and mediastinal disorders
Bronchiectasis	1/350 (0.3%)	1
Chronic obstructive pulmonary disease	1/350 (0.3%)	1
Epistaxis	1/350 (0.3%)	1
Pulmonary fibrosis	1/350 (0.3%)	1
Skin and subcutaneous tissue disorders
Skin irritation	1/350 (0.3%)	1
Skin lesion	1/350 (0.3%)	1
Skin ulcer	1/350 (0.3%)	1
Vascular disorders
Deep vein thrombosis	1/350 (0.3%)	1
Haematoma	1/350 (0.3%)	1
Hypertensive crisis	1/350 (0.3%)	1
Labile hypertension	1/350 (0.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.