Trial Outcomes & Findings for KAVIAR Study - Kyphoplasty And Vertebroplasty In the Augmentation and Restoration of Vertebral Body Compression Fractures (NCT NCT00323609)

NCT ID: NCT00323609

Last Updated: 2018-01-02

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 404 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2018-01-02

Participant Flow

Participant milestones

Measure	Kyphoplasty This group of patients has received balloon kyphoplasty procedure.	Vertebroplasty This group of patients has received vertebroplasty procedure.	Kyphoplasty Not Treated Patients Patients who met the enrollment criteria at screening and were randomized to treatment group had terminated prior to surgery or those who no longer met the inclusion criteria prior to surgery.	Vertebroplasty Not Treated Patients Patients who met the enrollment criteria at screening and were randomized to treatment group had terminated prior to surgery or those who no longer met the inclusion criteria prior to surgery.
Overall Study STARTED	191	190	8	15
Overall Study COMPLETED	100	91	0	0
Overall Study NOT COMPLETED	91	99	8	15

Reasons for withdrawal

Measure	Kyphoplasty This group of patients has received balloon kyphoplasty procedure.	Vertebroplasty This group of patients has received vertebroplasty procedure.	Kyphoplasty Not Treated Patients Patients who met the enrollment criteria at screening and were randomized to treatment group had terminated prior to surgery or those who no longer met the inclusion criteria prior to surgery.	Vertebroplasty Not Treated Patients Patients who met the enrollment criteria at screening and were randomized to treatment group had terminated prior to surgery or those who no longer met the inclusion criteria prior to surgery.
Overall Study Death	16	21	0	0
Overall Study Lost to Follow-up	9	10	0	0
Overall Study Physician Decision	2	0	0	1
Overall Study Withdrawal by Subject	11	23	4	4
Overall Study Other non-VCF-related medical condition	3	2	0	0
Overall Study Sponsor discontinued trial	29	29	0	0
Overall Study Unrelenting or severe back pain	1	1	0	0
Overall Study Logistical withdrawal	9	5	0	1
Overall Study Other reason	11	8	4	9

Baseline Characteristics

KAVIAR Study - Kyphoplasty And Vertebroplasty In the Augmentation and Restoration of Vertebral Body Compression Fractures

Baseline characteristics by cohort

Measure	Kyphoplasty n=191 Participants This group of patients has received balloon kyphoplasty procedure.	Vertebroplasty n=190 Participants This group of patients has received vertebroplasty procedure.	Total n=381 Participants Total of all reporting groups
Age, Continuous	75.5 years STANDARD_DEVIATION 10.3 • n=5 Participants	75.7 years STANDARD_DEVIATION 10.5 • n=7 Participants	75.6 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	151 Participants n=5 Participants	144 Participants n=7 Participants	295 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	46 Participants n=7 Participants	86 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	8 participants n=5 Participants	2 participants n=7 Participants	10 participants n=5 Participants
Race/Ethnicity, Customized White	178 participants n=5 Participants	181 participants n=7 Participants	359 participants n=5 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Current Weight	154.0 lbs STANDARD_DEVIATION 40.2 • n=5 Participants	160.2 lbs STANDARD_DEVIATION 42.9 • n=7 Participants	157.1 lbs STANDARD_DEVIATION 41.6 • n=5 Participants
Current Height	63.8 inches STANDARD_DEVIATION 4.3 • n=5 Participants	64.5 inches STANDARD_DEVIATION 4.0 • n=7 Participants	64.1 inches STANDARD_DEVIATION 4.2 • n=5 Participants
Smoking Habit Never Smoked	92 participants n=5 Participants	84 participants n=7 Participants	176 participants n=5 Participants
Smoking Habit Former Smoker	68 participants n=5 Participants	84 participants n=7 Participants	152 participants n=5 Participants
Smoking Habit Current Smoker	31 participants n=5 Participants	22 participants n=7 Participants	53 participants n=5 Participants
Osteoporosis Cause Suspected or confirmed primary osteoporosis	179 participants n=5 Participants	172 participants n=7 Participants	351 participants n=5 Participants
Osteoporosis Cause Suspected or confirmed secondary osteoporosis	12 participants n=5 Participants	18 participants n=7 Participants	30 participants n=5 Participants
Number of patients with intend to treat VCFs One level of VCFs intend to treat	149 participants n=5 Participants	150 participants n=7 Participants	299 participants n=5 Participants
Number of patients with intend to treat VCFs Two levels of VCFs intend to treat	33 participants n=5 Participants	32 participants n=7 Participants	65 participants n=5 Participants
Number of patients with intend to treat VCFs Three levels of VCFs intend to treat	9 participants n=5 Participants	8 participants n=7 Participants	17 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at 12-months is indicated.

Outcome measures

Measure	Vertebroplasty n=131 Participants This group of patients has received vertebroplasty procedure.	Kyphoplasty n=140 Participants This group of patients has received balloon kyphoplasty procedure.
Percent of Subjects With One or More Subsequent Radiographic Fractures at 12 Months No subsequent VCF	56.5 percentage of participants	64.3 percentage of participants
Percent of Subjects With One or More Subsequent Radiographic Fractures at 12 Months One or more subsequent VCFs	43.5 percentage of participants	35.7 percentage of participants

PRIMARY outcome

Timeframe: 24 months

Population: Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at 24-months is indicated.

Outcome measures

Measure	Vertebroplasty n=111 Participants This group of patients has received vertebroplasty procedure.	Kyphoplasty n=110 Participants This group of patients has received balloon kyphoplasty procedure.
Percent of Subjects With One or More Subsequent Radiographic Fractures 24 Months No subsequence VCF	42.3 percentage of participants	50.9 percentage of participants
Percent of Subjects With One or More Subsequent Radiographic Fractures 24 Months One or more subsequence VCFs	57.7 percentage of participants	49.1 percentage of participants

SECONDARY outcome

Timeframe: 7 days, 30 days, 3 months, 12 months, 24 months post-operation

Population: Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at each time point are indicated; for subjects who have secondary surgery, the last value before the first secondary surgery was carried forward to the later time points.

Back pain was assessed on a 10-point Numerical Rating Scale (NRS) from 0 (no pain) to 10 (worst possible pain).

Outcome measures

Measure	Vertebroplasty n=190 Participants This group of patients has received vertebroplasty procedure.	Kyphoplasty n=191 Participants This group of patients has received balloon kyphoplasty procedure.
Back Pain Back pain at 7days (n=184, 180)	4.0 units on a scale Standard Deviation 2.5	4.2 units on a scale Standard Deviation 2.8
Back Pain Back pain at baseline (n=191, 190)	7.7 units on a scale Standard Deviation 1.8	7.8 units on a scale Standard Deviation 1.8
Back Pain Back pain at 30 days (n=169, 173)	3.5 units on a scale Standard Deviation 2.7	3.6 units on a scale Standard Deviation 2.9
Back Pain Back pain at 3 months (n=158, 156)	3.2 units on a scale Standard Deviation 2.8	3.3 units on a scale Standard Deviation 3.0
Back Pain Back pain at 12 months (n=142, 133)	3.5 units on a scale Standard Deviation 2.9	3.2 units on a scale Standard Deviation 3.0
Back Pain Back pain at 24 months (n=112, 108)	3.8 units on a scale Standard Deviation 3.0	3.7 units on a scale Standard Deviation 3.2

SECONDARY outcome

Timeframe: 30 days, 3 months, 12 months, 24 months post-operation

Population: Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at each time point are indicated; for subjects who have secondary surgery, the last value before the first secondary surgery was carried forward to the later time points.

The Oswestry Disability Index (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).

Outcome measures

Measure	Vertebroplasty n=190 Participants This group of patients has received vertebroplasty procedure.	Kyphoplasty n=191 Participants This group of patients has received balloon kyphoplasty procedure.
Back Function-Oswestry Disability Index ODI at baseline (n=191, 189)	57.8 units on a scale Standard Deviation 16.0	59.0 units on a scale Standard Deviation 17.5
Back Function-Oswestry Disability Index ODI at 30 days (n=164, 156)	34.6 units on a scale Standard Deviation 17.6	36.2 units on a scale Standard Deviation 19.8
Back Function-Oswestry Disability Index ODI at 3 months (n=153, 141)	30.8 units on a scale Standard Deviation 18.0	30.4 units on a scale Standard Deviation 18.6
Back Function-Oswestry Disability Index ODI at 12 months (n=138, 119)	28.2 units on a scale Standard Deviation 17.8	29.2 units on a scale Standard Deviation 18.1
Back Function-Oswestry Disability Index ODI at 24 months (n=108, 93)	30.8 units on a scale Standard Deviation 17.8	32.1 units on a scale Standard Deviation 19.4

SECONDARY outcome

Timeframe: 30 days, 3 months, 12 months, 24 months post-operation

Population: Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at each time point are indicated; for subjects who have secondary surgery, the last value before the first secondary surgery was carried forward to the later time points.

The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS and MCS is between 0 and 100, with higher scores denoting better quality of life.

Outcome measures

Measure	Vertebroplasty n=190 Participants This group of patients has received vertebroplasty procedure.	Kyphoplasty n=191 Participants This group of patients has received balloon kyphoplasty procedure.
Quality of Life by SF-36 SF-36 PCS at baseline (n=189, 190)	27.78 units on a scale Standard Deviation 8.20	27.92 units on a scale Standard Deviation 7.46
Quality of Life by SF-36 SF-36 PCS at 30 days (n=162, 155)	34.51 units on a scale Standard Deviation 9.69	33.09 units on a scale Standard Deviation 10.13
Quality of Life by SF-36 SF-36 PCS at 3 months (n=153, 138)	36.27 units on a scale Standard Deviation 10.66	36.06 units on a scale Standard Deviation 11.32
Quality of Life by SF-36 SF-36 PCS at 12 months (n=138, 118)	37.39 units on a scale Standard Deviation 11.09	36.07 units on a scale Standard Deviation 11.33
Quality of Life by SF-36 SF-36 PCS at 24 months (n=108, 92)	35.10 units on a scale Standard Deviation 9.98	34.94 units on a scale Standard Deviation 11.81
Quality of Life by SF-36 SF-36 MCS at baseline (n=189, 190)	43.38 units on a scale Standard Deviation 12.73	40.87 units on a scale Standard Deviation 13.37
Quality of Life by SF-36 SF-36 MCS at 30 days (n=162, 155)	47.43 units on a scale Standard Deviation 12.23	46.56 units on a scale Standard Deviation 12.83
Quality of Life by SF-36 SF-36 MCS at 3 months (n=153, 138)	49.85 units on a scale Standard Deviation 11.16	49.86 units on a scale Standard Deviation 11.62
Quality of Life by SF-36 SF-36 MCS at 12 months (n=138, 118)	49.99 units on a scale Standard Deviation 11.14	50.84 units on a scale Standard Deviation 11.75
Quality of Life by SF-36 SF-36 MCS at 24 months (n=108, 92)	48.66 units on a scale Standard Deviation 12.24	48.84 units on a scale Standard Deviation 13.35

SECONDARY outcome

Timeframe: 30 days, 3 months, 12 months, 24 months post-operation

Population: Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data at each time point are indicated; for subjects who have secondary surgery, the last value before the first secondary surgery was carried forward to the later time points.

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

Outcome measures

Measure	Vertebroplasty n=190 Participants This group of patients has received vertebroplasty procedure.	Kyphoplasty n=191 Participants This group of patients has received balloon kyphoplasty procedure.
Quality of Life -- EQ5D Index EQ5D index at baseline (n=189,189)	0.42 units on a scale Standard Deviation 0.24	0.44 units on a scale Standard Deviation 0.26
Quality of Life -- EQ5D Index EQ5D index at 30 days (n=164, 156)	0.71 units on a scale Standard Deviation 0.19	0.70 units on a scale Standard Deviation 0.19
Quality of Life -- EQ5D Index EQ5D index at 3 months (n=152, 140)	0.75 units on a scale Standard Deviation 0.17	0.75 units on a scale Standard Deviation 0.18
Quality of Life -- EQ5D Index EQ5D index at 12 months (n=137, 119)	0.77 units on a scale Standard Deviation 0.16	0.76 units on a scale Standard Deviation 0.18
Quality of Life -- EQ5D Index EQ5D index at 24 months (n=108, 94)	0.74 units on a scale Standard Deviation 0.19	0.72 units on a scale Standard Deviation 0.22

SECONDARY outcome

Timeframe: 30 days post-operation

Population: Intent to treat population comprised of all subjects randomized and had initial treatment carried out.

Rate of serious adverse events is presented as the percentage of the participants who reported serious adverse events within 30 days after initial treatment. For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.

Outcome measures

Measure	Vertebroplasty n=190 Participants This group of patients has received vertebroplasty procedure.	Kyphoplasty n=191 Participants This group of patients has received balloon kyphoplasty procedure.
Rate of Serious Adverse Events at 30 Days	27.4 percentage of participants	26.2 percentage of participants

SECONDARY outcome

Timeframe: 30 days post-operation

Population: Intent to treat population comprised of all subjects randomized and had initial treatment carried out.

Rate of Procedure/Device related or possibly related serious adverse events is presented as the percentage of the participants who reported Procedure/Device related or possibly related serious adverse events within 30 days after initial treatment.

Outcome measures

Measure	Vertebroplasty n=190 Participants This group of patients has received vertebroplasty procedure.	Kyphoplasty n=191 Participants This group of patients has received balloon kyphoplasty procedure.
Rate of Procedure/Device Related or Possibly Related Serious Adverse Events at 30 Days	4.2 percentage of participants	4.2 percentage of participants

SECONDARY outcome

Timeframe: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation

Population: Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data (vertebrae) at each time point are indicated. The number of participants analyzed in 'Change in Anterior Vertebral Body Height' represents number of subjects with radiographic data available for analysis.

Outcome measures

Measure	Vertebroplasty n=224 treated vertebrae This group of patients has received vertebroplasty procedure.	Kyphoplasty n=232 treated vertebrae This group of patients has received balloon kyphoplasty procedure.
Change in Anterior Vertebral Body Height Estimated Pre-Fracture (EP) height (n=231, 222)	24.49 mm Standard Deviation 4.09	24.32 mm Standard Deviation 3.93
Change in Anterior Vertebral Body Height Vertebral body height at Pre-op (n=224, 212)	15.15 mm Standard Deviation 6.04	15.91 mm Standard Deviation 5.79
Change in Anterior Vertebral Body Height Height Loss from EP/Absolute Height Loss (AHL)	-9.22 mm Standard Deviation 5.15	-8.43 mm Standard Deviation 4.47
Change in Anterior Vertebral Body Height Change from pre-op to pre-discharge (n=217, 200)	2.40 mm Standard Deviation 3.03	2.51 mm Standard Deviation 3.19
Change in Anterior Vertebral Body Height Change from pre-op to 3 months (n=176, 157)	1.23 mm Standard Deviation 3.13	1.26 mm Standard Deviation 2.99
Change in Anterior Vertebral Body Height Change from pre-op to 12 months (n=158, 128)	1.05 mm Standard Deviation 2.96	1.33 mm Standard Deviation 3.12
Change in Anterior Vertebral Body Height Change from pre-op to 24 months (n=101, 93)	0.75 mm Standard Deviation 3.05	1.00 mm Standard Deviation 3.08

SECONDARY outcome

Timeframe: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation

Population: Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data (vertebrae) at each time point are indicated. The number of participants analyzed in 'Change in Middle Vertebral Body Height' represents number of subjects with radiographic data available for analysis.

Outcome measures

Measure	Vertebroplasty n=224 treated vertebrae This group of patients has received vertebroplasty procedure.	Kyphoplasty n=232 treated vertebrae This group of patients has received balloon kyphoplasty procedure.
Change in Middle Vertebral Body Height Estimated Pre-Fracture Height (EP) (n=231, 222)	23.68 mm Standard Deviation 3.58	23.45 mm Standard Deviation 3.46
Change in Middle Vertebral Body Height Vertebral body height at pre-op (n=225, 211)	15.92 mm Standard Deviation 5.12	16.08 mm Standard Deviation 5.08
Change in Middle Vertebral Body Height Height loss from EP/ Absolute Height Loss (AHL)	-7.60 mm Standard Deviation 4.09	-7.42 mm Standard Deviation 4.06
Change in Middle Vertebral Body Height change from pre-op at pre-discharge (n=219, 200)	1.84 mm Standard Deviation 2.38	2.33 mm Standard Deviation 2.72
Change in Middle Vertebral Body Height Change from pre-op at 3 months (n=177, 159)	1.18 mm Standard Deviation 2.55	1.34 mm Standard Deviation 2.59
Change in Middle Vertebral Body Height Change from pre-op at 12 months (n=161, 128)	0.92 mm Standard Deviation 2.51	1.31 mm Standard Deviation 2.80
Change in Middle Vertebral Body Height Change from pre-op at 24 months (n=104, 92)	0.67 mm Standard Deviation 2.78	0.98 mm Standard Deviation 2.58

SECONDARY outcome

Timeframe: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation

Population: Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data (vertebrae) at each time point are indicated. The number of participants analyzed in 'Change in Posterior Vertebral Body Height' represents number of subjects with radiographic data available for analysis.

Outcome measures

Measure	Vertebroplasty n=224 treated vertebrae This group of patients has received vertebroplasty procedure.	Kyphoplasty n=232 treated vertebrae This group of patients has received balloon kyphoplasty procedure.
Change in Posterior Vertebral Body Height Vertebral body height at pre-op (n=225, 210)	23.47 mm Standard Deviation 4.36	23.41 mm Standard Deviation 4.11
Change in Posterior Vertebral Body Height Height Loss from EP/Absolute Height Loss (AHL)	-2.49 mm Standard Deviation 2.46	-2.52 mm Standard Deviation 2.47
Change in Posterior Vertebral Body Height Estimated Pre-Fracture Height (n=231, 222)	26.10 mm Standard Deviation 3.67	25.89 mm Standard Deviation 3.45
Change in Posterior Vertebral Body Height Change from pre-op to pre-discharge (n=220, 199)	0.49 mm Standard Deviation 1.50	0.82 mm Standard Deviation 1.74
Change in Posterior Vertebral Body Height Change from pre-op to 3 months (n=179, 160)	0.06 mm Standard Deviation 1.63	0.10 mm Standard Deviation 1.64
Change in Posterior Vertebral Body Height Change from pre-op to 12 months (n=161, 129)	-0.00 mm Standard Deviation 1.78	-0.03 mm Standard Deviation 1.79
Change in Posterior Vertebral Body Height Change from pre-op to 24 months (n=104, 93)	-0.30 mm Standard Deviation 1.79	-0.21 mm Standard Deviation 1.55

SECONDARY outcome

Timeframe: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation

Population: Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data (vertebrae) at each time point are indicated. The number of participants analyzed in 'Change in Vertebral Body Kyphosis Angle' represents number of subjects with radiographic data available for analysis.

The vertebral kyphosis angle was defined as the angle formed by lines drawn parallel to the superior and inferior endplates of the treated fractured vertebral body.

Outcome measures

Measure	Vertebroplasty n=224 treated vertebrae This group of patients has received vertebroplasty procedure.	Kyphoplasty n=232 treated vertebrae This group of patients has received balloon kyphoplasty procedure.
Change in Vertebral Body Kyphosis Angle Kyphosis angle at pre-op (n=219, 210)	-15.68 degree Standard Deviation 8.12	-14.17 degree Standard Deviation 8.29
Change in Vertebral Body Kyphosis Angle Change from pre-op to pre-discharge (n=213, 195)	3.41 degree Standard Deviation 5.67	3.10 degree Standard Deviation 5.22
Change in Vertebral Body Kyphosis Angle Change from pre-op to 3 months (n=168, 155)	2.28 degree Standard Deviation 5.72	1.78 degree Standard Deviation 5.25
Change in Vertebral Body Kyphosis Angle Change from pre-op to 12 months (n=154, 127)	1.51 degree Standard Deviation 5.30	1.97 degree Standard Deviation 5.38
Change in Vertebral Body Kyphosis Angle Change from pre-op to 24 months (n=99, 92)	1.43 degree Standard Deviation 5.01	2.09 degree Standard Deviation 5.95

SECONDARY outcome

Timeframe: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation

Population: Intent to treat population comprised of all subjects randomized and had initial treatment carried out. The n for each group with available data (vertebrae) at each time point are indicated. The number of participants analyzed in 'Change in Vertebral Body Local Cobb Angle' represents number of subjects with radiographic data available for analysis.

The vertebral body local Cobb angle is a measurement of the 3-level functional unit consisting of the treated fractured vertebral body and the nearest adjacent vertebrae and is defined as the angle formed by lines drawn parallel to the superior endplate of the cranial adjacent vertebral body and the inferior endplate of the adjacent caudal vertebral body.

Outcome measures

Measure	Vertebroplasty n=224 treated vertebrae This group of patients has received vertebroplasty procedure.	Kyphoplasty n=232 treated vertebrae This group of patients has received balloon kyphoplasty procedure.
Change in Vertebral Body Local Cobb Angle (LCA) Vertebral body LCA at pre-op (n=213, 203)	-15.48 degree Standard Deviation 18.67	-14.00 degree Standard Deviation 19.71
Change in Vertebral Body Local Cobb Angle (LCA) Change from pre-op to pre-discharge (n=203, 186)	2.84 degree Standard Deviation 4.33	2.37 degree Standard Deviation 5.84
Change in Vertebral Body Local Cobb Angle (LCA) Change from pre-op to 3 months (n=166, 146)	-0.43 degree Standard Deviation 6.67	-0.22 degree Standard Deviation 5.46
Change in Vertebral Body Local Cobb Angle (LCA) Change from pre-op to 12 months (n=151, 118)	0.03 degree Standard Deviation 8.15	0.38 degree Standard Deviation 10.15
Change in Vertebral Body Local Cobb Angle (LCA) Change from pre-op to 24 months (n=98, 85)	-0.57 degree Standard Deviation 6.35	-1.15 degree Standard Deviation 8.43

SECONDARY outcome

Timeframe: Pre-op, Pre-discharge, 3 months, 12 months, 24 months post-operation

Population: Due to the early termination of the study and having few sites able to image using 3-foot lateral films, sponsor will not carry out the analysis of global sagittal balance in the clinic report.

Change in global sagittal balance as measured by sagittal vertical axis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Monthly for 24 months post-op

Population: Due to the early termination of the study, sponsor will not carry out the analysis of secondary healthcare utilization endpoints.

Health care utilization assessments conducted by monthly phone call to participating patients.

Outcome measures

Outcome data not reported

Adverse Events

Kyphoplasty

Serious events: 125 serious events

Other events: 55 other events

Deaths: 0 deaths

Vertebroplasty

Serious events: 125 serious events

Other events: 69 other events

Deaths: 0 deaths

Serious adverse events

Measure	Kyphoplasty n=191 participants at risk This group of patients has received balloon kyphoplasty procedure.	Vertebroplasty n=190 participants at risk This group of patients has received vertebroplasty procedure.
Blood and lymphatic system disorders Anaemia	3.1% 6/191 • Number of events 7 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	2.1% 4/190 • Number of events 4 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Blood and lymphatic system disorders Coagulopathy	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Blood and lymphatic system disorders Heparin-induced thrombocytopenia	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Blood and lymphatic system disorders Polycythaemia	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Cardiac disorders Acute coronary syndrome	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Cardiac disorders Angina pectoris	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.6% 3/190 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Cardiac disorders Aortic valve stenosis	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Cardiac disorders Atrial fibrillation	3.1% 6/191 • Number of events 7 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	2.6% 5/190 • Number of events 5 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Cardiac disorders Cardiac arrest	0.52% 1/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.6% 3/190 • Number of events 4 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Cardiac disorders Cardiac failure	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Cardiac disorders Cardiac failure congestive	3.1% 6/191 • Number of events 6 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	5.3% 10/190 • Number of events 18 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Cardiac disorders Cardio-respiratory arrest	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Cardiac disorders Cardiomyopathy	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Cardiac disorders Chest pain	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Cardiac disorders Coronary artery disease	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Cardiac disorders Coronary artery occlusion	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Cardiac disorders Coronary artery stenosis	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Cardiac disorders Heart valve incompetence	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Cardiac disorders Mitral valve incompetence	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Cardiac disorders Myocardial infarction	2.1% 4/191 • Number of events 5 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.6% 3/190 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Cardiac disorders Palpitations	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Cardiac disorders Tachycardia	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Cardiac disorders Ventricular tachycardia	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Ear and labyrinth disorders Cerumen impaction	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Ear and labyrinth disorders Deafness neurosensory	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Ear and labyrinth disorders Hearing impaired	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Ear and labyrinth disorders Hypoacusis	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Ear and labyrinth disorders Vertigo	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Endocrine disorders Hypothyroidism	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Eye disorders Cataract	1.6% 3/191 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.6% 3/190 • Number of events 4 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Eye disorders Conjunctival haemorrhage	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Eye disorders Diplopia	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Eye disorders Sjogren's syndrome	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Abdominal distension	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders abdominal pain	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	3.2% 6/190 • Number of events 6 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders abdominal pain upper	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Colitis	1.0% 2/191 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Constipation	2.1% 4/191 • Number of events 5 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	3.2% 6/190 • Number of events 6 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Crohn's disease	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Diarrhoea	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Dry mouth	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Dysphagia	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Gastric haemorrhage	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Gastric polyps	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Gastritis	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	2.6% 5/190 • Number of events 5 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Haemorrhoids	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Hiatus hernia	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Ileus paralytic	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Inguinal hernia	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Intestinal obstruction	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Nausea	1.6% 3/191 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	2.6% 5/190 • Number of events 6 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Oesophageal obstruction	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Pancreatic cyst	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Pancreatitis	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Rectal haemorrhage	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Rectal prolapse	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Vomiting	1.6% 3/191 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	2.6% 5/190 • Number of events 6 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Peptic ulcer	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Proctitis	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
General disorders Adverse drug reaction	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
General disorders Asthenia	0.52% 1/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
General disorders Chest pain	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	2.1% 4/190 • Number of events 4 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
General disorders Death	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.6% 3/190 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
General disorders Generalised oedema	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
General disorders Influenza like illness	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
General disorders Non-cardiac chest pain	1.6% 3/191 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
General disorders Oedema peripheral	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	2.1% 4/190 • Number of events 5 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
General disorders Pain	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
General disorders Pyrexia	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
General disorders Systemic inflammatory response syndrome	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Hepatobiliary disorders Bile duct stone	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Hepatobiliary disorders Cholecystitis chronic	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Hepatobiliary disorders Cholelithiasis	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Immune system disorders Drug hypersensitivity	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Immune system disorders Hypersensitivity	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Abscess	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Abscess oral	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Appendicitis	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Bacteraemia	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Bronchitis	5.2% 10/191 • Number of events 11 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	3.7% 7/190 • Number of events 11 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Cellulitis	1.6% 3/191 • Number of events 4 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.6% 3/190 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Clostridial infection	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Clostridium difficile colitis	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Corynebacterium infection	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Encephalitis viral	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Endocarditis	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Gastroenteritis	1.6% 3/191 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Gastroenteritis bacterial	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Gastroenteritis viral	1.0% 2/191 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Herpes zoster	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Hordeolum	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Infection	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Localised infection	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Nasopharyngitis	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Onychomycosis	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Otitis media	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Otitis media chronic	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Pneumonia	7.3% 14/191 • Number of events 16 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	6.3% 12/190 • Number of events 18 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Pneumonia pneumococcal	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Pyelonephritis	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Rhinitis	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Sepsis	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Sepsis syndrome	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Septic shock	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Sinusitis	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Skin infection	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Staphylococcal abscess	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Staphylococcal sepsis	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Streptococcal infection	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Subcutaneous abscess	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Upper respiratory tract infection	3.1% 6/191 • Number of events 7 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	3.2% 6/190 • Number of events 6 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Urinary tract infection	5.2% 10/191 • Number of events 16 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	9.5% 18/190 • Number of events 24 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Urinary tract infection enterococcal	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Viral infection	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Wound infection	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Accident	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Acetabulum fracture	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Arthropod sting	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Back injury	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Bone fissure	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Burns second degree	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Catheter site haemorrhage	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Cement embolism	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Clavicle fracture	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Contusion	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	2.1% 4/190 • Number of events 4 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Dural tear	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Excoriation	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Fall	15.7% 30/191 • Number of events 44 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	16.8% 32/190 • Number of events 39 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Femur fracture	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Foot fracture	1.0% 2/191 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Fractured sacrum	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Head injury	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Hip fracture	2.6% 5/191 • Number of events 5 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	2.6% 5/190 • Number of events 5 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Humerus fracture	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Joint injury	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Joint sprain	1.6% 3/191 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Laceration	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Limb injury	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Low limb fracture	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Mental status changes postoperative	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Muscle strain	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Pelvic fracture	2.1% 4/191 • Number of events 4 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.6% 3/190 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Peripheral nerve injury	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Procedural hypotension	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Procedural nausea	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Procedural pain	3.7% 7/191 • Number of events 7 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	3.7% 7/190 • Number of events 8 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Procedural vomiting	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Pubis fracture	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Rib fracture	3.7% 7/191 • Number of events 7 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Road traffic accident	1.6% 3/191 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Skin laceration	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Spinal fracture	1.6% 3/191 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Subdural haematoma	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Tibia fracture	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Traumatic brain injury	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Traumatic haematoma	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Upper limb fracture	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Wound haemorrhage	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Wrist fracture	2.1% 4/191 • Number of events 4 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Investigations Aspiration tracheal	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Investigations Haemoglobin decreased	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Investigations White blood cell count increased	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Metabolism and nutrition disorders Abnormal loss weight	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Metabolism and nutrition disorders Adrenal insufficiency	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Metabolism and nutrition disorders Decreased appetite	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Metabolism and nutrition disorders Dehydration	2.6% 5/191 • Number of events 6 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Metabolism and nutrition disorders Diabetic complication	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Metabolism and nutrition disorders Failure to thrive	0.52% 1/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Metabolism and nutrition disorders Fluid retention	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Metabolism and nutrition disorders Gout	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Metabolism and nutrition disorders Hypocalcaemia	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Metabolism and nutrition disorders Hypoglycaemia	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Metabolism and nutrition disorders Hypokalaemia	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Metabolism and nutrition disorders Hyponatraemia	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Metabolism and nutrition disorders Hypovolaemia	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Metabolism and nutrition disorders Malnutrition	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Metabolism and nutrition disorders Metabolic acidosis	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Metabolism and nutrition disorders Shock hypoglycaemic	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Metabolism and nutrition disorders Vitamin B12 deficiency	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Arthralgia	7.9% 15/191 • Number of events 22 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	3.7% 7/190 • Number of events 8 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Arthritis	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Arthropathy	1.6% 3/191 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Back pain	22.0% 42/191 • Number of events 63 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	22.1% 42/190 • Number of events 69 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Bunion	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Coccydynia	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Congenital jaw malformation	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Contusion	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Facet joint syndrome	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Flank pain	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.6% 3/190 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Gout	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Groin pain	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Iliotibial band syndrome	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Joint effusion	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	1.6% 3/191 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Lumbar vertebral fracture	4.7% 9/191 • Number of events 13 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	6.8% 13/190 • Number of events 18 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Muscle spasms	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Muscle tightness	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Muscular weakness	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	2.1% 4/190 • Number of events 4 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	2.6% 5/191 • Number of events 7 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	2.6% 5/190 • Number of events 6 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Myalgia	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Neck pain	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	2.6% 5/190 • Number of events 5 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Osteoarthritis	2.1% 4/191 • Number of events 4 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.6% 3/190 • Number of events 6 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Pain in extremity	2.1% 4/191 • Number of events 4 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	4.2% 8/190 • Number of events 9 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Restless legs syndrome	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	1.6% 3/191 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Sacroiliitis	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Sinus tarsi syndrome	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Spinal fracture	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Thoracic vertebral fracture	9.9% 19/191 • Number of events 24 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	10.0% 19/190 • Number of events 29 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal cancer	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer metastatic	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.52% 1/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Monoclonal gammopathy	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Multiple myeloma	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paraproteinaemia	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Polyp	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cyst	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine carcinoma	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid neoplasm	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Nervous system disorders Amnesia	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Nervous system disorders Cerebrovascular accident	2.6% 5/191 • Number of events 5 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Nervous system disorders Convulsion	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Nervous system disorders Depressed level of consciousness	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Nervous system disorders Dizziness	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	2.6% 5/190 • Number of events 7 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Nervous system disorders Encephalopathy	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Nervous system disorders Haemorrhagic stroke	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Nervous system disorders Headache	1.0% 2/191 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	2.6% 5/190 • Number of events 6 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Nervous system disorders Intracranial aneurysm	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Nervous system disorders Lethargy	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Nervous system disorders Loss of consciousness	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Nervous system disorders Lumbar radiculopathy	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Nervous system disorders Neuralgia	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Nervous system disorders Parkinson's disease	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Nervous system disorders Piriformis syndrome	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Nervous system disorders Radicular pain	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Nervous system disorders Sciatica	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Nervous system disorders Spinal cord compression	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Nervous system disorders Subarachnoid haemorrhage	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Nervous system disorders Syncope	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.6% 3/190 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Nervous system disorders Toxic neuropathy	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Nervous system disorders Transient ischaemic attack	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Psychiatric disorders Abnormal behaviour	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Psychiatric disorders Anxiety	1.0% 2/191 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Psychiatric disorders Confusional state	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Psychiatric disorders Dementia	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Psychiatric disorders Depression	2.1% 4/191 • Number of events 5 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Psychiatric disorders Hallucination	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Renal and urinary disorders Haematuria	0.52% 1/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Renal and urinary disorders Hydronephrosis	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.6% 3/190 • Number of events 5 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Renal and urinary disorders Hypertonic bladder	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Renal and urinary disorders Ketonuria	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Renal and urinary disorders Nephrolithiasis	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Renal and urinary disorders Polyuria	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Renal and urinary disorders Proteinuria	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Renal and urinary disorders Renal failure	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Renal and urinary disorders Renal failure acute	2.1% 4/191 • Number of events 4 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Renal and urinary disorders Renal failure chronic	1.0% 2/191 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Renal and urinary disorders Renal pain	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Renal and urinary disorders Stress urinary incontinence	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Renal and urinary disorders Ureteric stenosis	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Renal and urinary disorders Urge incontinence	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Renal and urinary disorders Urinary retention	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Reproductive system and breast disorders Breast pain	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Reproductive system and breast disorders Postmenopausal haemorrhage	1.6% 3/191 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Reproductive system and breast disorders Prostatitis	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Reproductive system and breast disorders Uterine prolapse	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Respiratory, thoracic and mediastinal disorders Asthma	1.6% 3/191 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 5 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	2.6% 5/191 • Number of events 9 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	4.2% 8/190 • Number of events 11 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Respiratory, thoracic and mediastinal disorders Cough	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.6% 3/190 • Number of events 4 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	2.6% 5/190 • Number of events 6 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Respiratory, thoracic and mediastinal disorders Oropharyngeal blistering	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.6% 3/191 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Respiratory, thoracic and mediastinal disorders Bronchitis	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.52% 1/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Respiratory, thoracic and mediastinal disorders Sleep apnea syndrome	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Skin and subcutaneous tissue disorders Dermatitis contact	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Skin and subcutaneous tissue disorders Dyshidrosis	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Skin and subcutaneous tissue disorders Hyperkeratosis	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Skin and subcutaneous tissue disorders Ingrowing nail	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Skin and subcutaneous tissue disorders Pemphigoid	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Skin and subcutaneous tissue disorders Pruritus	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Skin and subcutaneous tissue disorders Rash	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Skin and subcutaneous tissue disorders Skin ulcer	1.0% 2/191 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Surgical and medical procedures Adenotonsillectomy	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Surgical and medical procedures Cataract operation	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Surgical and medical procedures Coronary angioplasty	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Surgical and medical procedures Knee arthroplasty	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Surgical and medical procedures Small intestinal resection	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Surgical and medical procedures Spinal laminectomy	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Vascular disorders Aortic aneurysm	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Vascular disorders Aortic dissection	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Vascular disorders Carotid artery stenosis	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Vascular disorders Deep vein thrombosis	1.6% 3/191 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Vascular disorders Hypertension	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Vascular disorders Hypotension	1.0% 2/191 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Vascular disorders Intermittent claudication	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Vascular disorders Lymphoedema	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Vascular disorders Migraine	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Vascular disorders Orthostatic hypotension	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Vascular disorders Peripheral vascular disorder	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Vascular disorders Venous insufficiency	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.

Other adverse events

Measure	Kyphoplasty n=191 participants at risk This group of patients has received balloon kyphoplasty procedure.	Vertebroplasty n=190 participants at risk This group of patients has received vertebroplasty procedure.
Blood and lymphatic system disorders Anaemia	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Blood and lymphatic system disorders Bone marrow oedema	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Cardiac disorders Mitral valve incompetence	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Cardiac disorders Supraventricular tachycardia	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Ear and labyrinth disorders Eustachian tube dysfunction	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Ear and labyrinth disorders Inner ear disorder	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Ear and labyrinth disorders Vertigo	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Endocrine disorders Goitre	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Eye disorders Vitreous detachment	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Abdominal pain lower	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Anal haemorrhage	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Diarrhoea	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Frequent bowel movements	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Hiatus hernia	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Nausea	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Retching	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Stomatitis	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Gastrointestinal disorders Vomiting	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
General disorders Asthenia	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
General disorders Chest pain	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
General disorders Injection site haematoma	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
General disorders Non-cardiac chest pain	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Bronchitis	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.6% 3/190 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Gastroenteritis	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Nasopharyngitis	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Urinary tract infection	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Infections and infestations Viral infection	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Acetabulum fracture	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Back injury	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.6% 3/190 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Back pain	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Contusion	1.0% 2/191 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Fall	12.0% 23/191 • Number of events 28 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	10.5% 20/190 • Number of events 24 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Ilium fracture	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Implant site extravasation	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Joint injury	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Joint sprain	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Limb injury	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Post-traumatic pain	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Procedural pain	2.6% 5/191 • Number of events 5 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Rib fracture	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	2.1% 4/190 • Number of events 4 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Road traffic accident	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Skeletal injury	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Soft tissue injury	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Injury, poisoning and procedural complications Traumatic haematoma	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Investigations Immunoglobulins increased	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Metabolism and nutrition disorders Abnormal loss of weight	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Metabolism and nutrition disorders Adrenal insufficiency	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Metabolism and nutrition disorders Failure to thrive	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Metabolism and nutrition disorders Hyperglycaemia	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Metabolism and nutrition disorders Hyperkalaemia	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Arthralgia	2.1% 4/191 • Number of events 4 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	2.6% 5/190 • Number of events 5 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Back pain	4.7% 9/191 • Number of events 10 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	10.0% 19/190 • Number of events 20 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Coccydynia	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Facet joint syndrome	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Joint swelling	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Lumbar vertebral fracture	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Muscle spasms	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Muscle strain	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Muscular weakness	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.6% 3/190 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Neck pain	1.6% 3/191 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.6% 3/190 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Pain in extremity	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Spinal fracture	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Musculoskeletal and connective tissue disorders Thoracic vertebral fracture	1.6% 3/191 • Number of events 4 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.6% 3/190 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vaginal neoplasm	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Nervous system disorders Dizziness	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.1% 2/190 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Nervous system disorders Grand mal convulsion	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Nervous system disorders Headache	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Nervous system disorders Hypoaesthesia	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.6% 3/190 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Nervous system disorders Lethargy	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Nervous system disorders Migraine	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Nervous system disorders Nystagmus	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Nervous system disorders Paraesthesia	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Nervous system disorders Polyneuropathy	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Nervous system disorders Syncope	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Nervous system disorders Tremor	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Nervous system disorders Vocal cord paralysis	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Psychiatric disorders Confusional state	0.52% 1/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Reproductive system and breast disorders Ovarian mass	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Reproductive system and breast disorders Vaginal haemorrhage	1.0% 2/191 • Number of events 2 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	1.6% 3/190 • Number of events 3 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Skin and subcutaneous tissue disorders Rash	0.52% 1/191 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.00% 0/190 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Vascular disorders Haematoma	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.
Vascular disorders Hypotension	0.00% 0/191 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.	0.53% 1/190 • Number of events 1 • 24 months For this study, serious adverse events (SAEs) included death, serious deterioration in health, life threatening injury/illness, hospitalization or prolonged hospitalization, or resulted in medical or surgical intervention.

Additional Information

John Tillman

Medtronic

Phone: 408-548-6518

Email: tillmj1@mspexcng.medtronic.com

Results disclosure agreements

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

Restriction type: LTE60