Trial Outcomes & Findings for Extension Study to Evaluate the Long Term Safety and Efficacy of Denosumab in the Treatment of Osteoporosis (NCT NCT00523341)

NCT ID: NCT00523341

Last Updated: 2022-11-07

Results Overview

A serious adverse event (SAE) is defined as an adverse event that: • is fatal • is life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • is other significant medical hazard. Treatment-related adverse events includes only events for which the investigator indicated there was a reasonable possibility they may have been caused by study drug. The following were classified as adverse events of interest (events that are considered to be identified or potential risks of denosumab treatment): positively adjudicated osteonecrosis of the jaw, positively adjudicated atypical femoral fracture, hypocalcemia, adverse events potentially related to hypersensitivity, serious infection (including bacterial cellulitis), malignancy, cardiac disorders, vascular disorders, fracture healing complications, eczema, acute pancreatitis, and musculoskeletal pain.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 4550 participants
• Primary outcome timeframe: 84 months
• Results posted on: 2022-11-07

Participant Flow

This was an extension study open to participants who had completed core study 20030216 (NCT00089791). The study was conducted at 178 centers in North America, South America, Europe, Australia, and New Zealand. Participants were enrolled from 7 August 2007 to 20 June 2008.

All participants received open-label denosumab during this study. Results are reported by the Study 20030216 randomized treatment groups (placebo versus denosumab).

Participant milestones

Measure	Placebo / Denosumab Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Overall Study STARTED	2207	2343
Overall Study Received Treatment	2206	2343
Overall Study COMPLETED	1283	1343
Overall Study NOT COMPLETED	924	1000

Reasons for withdrawal

Measure	Placebo / Denosumab Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Overall Study Withdrawal by Subject	399	427
Overall Study Other	181	198
Overall Study Adverse Event	122	155
Overall Study Death	101	110
Overall Study Lost to Follow-up	73	61
Overall Study Non-compliance	20	13
Overall Study Physician Decision	14	13
Overall Study Requirement for Alternative Therapy	4	14
Overall Study Protocol Deviation	6	5
Overall Study Ineligibility Determined	3	4
Overall Study Disease Progression	1	0

Baseline Characteristics

Extension Study to Evaluate the Long Term Safety and Efficacy of Denosumab in the Treatment of Osteoporosis

Baseline characteristics by cohort

Measure	Denosumab / Denosumab n=2343 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).	Total n=4550 Participants Total of all reporting groups	Placebo / Denosumab n=2207 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
Age, Continuous	74.9 years STANDARD_DEVIATION 5.0 • n=7 Participants	74.8 years STANDARD_DEVIATION 5.0 • n=5 Participants	74.8 years STANDARD_DEVIATION 5.1 • n=5 Participants
Age, Customized 60 - 64 years	49 participants n=7 Participants	107 participants n=5 Participants	58 participants n=5 Participants
Age, Customized 65 - 69 years	320 participants n=7 Participants	646 participants n=5 Participants	326 participants n=5 Participants
Age, Customized 70 - 74 years	716 participants n=7 Participants	1388 participants n=5 Participants	672 participants n=5 Participants
Age, Customized ≥ 75 years	1258 participants n=7 Participants	2409 participants n=5 Participants	1151 participants n=5 Participants
Sex: Female, Male Female	2343 Participants n=7 Participants	4550 Participants n=5 Participants	2207 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	2169 participants n=7 Participants	4232 participants n=5 Participants	2063 participants n=5 Participants
Race/Ethnicity, Customized Black	19 participants n=7 Participants	35 participants n=5 Participants	16 participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	145 participants n=7 Participants	266 participants n=5 Participants	121 participants n=5 Participants
Race/Ethnicity, Customized Asian	3 participants n=7 Participants	5 participants n=5 Participants	2 participants n=5 Participants
Race/Ethnicity, Customized Japanese	5 participants n=7 Participants	8 participants n=5 Participants	3 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Other	2 participants n=7 Participants	3 participants n=5 Participants	1 participants n=5 Participants
Bone Mineral Density T-score Lumbar spine	-2.14 T-score STANDARD_DEVIATION 0.80 • n=7 Participants	-2.47 T-score STANDARD_DEVIATION 0.84 • n=5 Participants	-2.81 T-score STANDARD_DEVIATION 0.75 • n=5 Participants
Bone Mineral Density T-score Total hip	-1.50 T-score STANDARD_DEVIATION 0.79 • n=7 Participants	-1.71 T-score STANDARD_DEVIATION 0.83 • n=5 Participants	-1.93 T-score STANDARD_DEVIATION 0.80 • n=5 Participants
Bone Mineral Density T-score Femoral neck	-1.83 T-score STANDARD_DEVIATION 0.75 • n=7 Participants	-1.99 T-score STANDARD_DEVIATION 0.75 • n=5 Participants	-2.17 T-score STANDARD_DEVIATION 0.72 • n=5 Participants
Bone Mineral Density T-score at Study 20030216 Baseline Lumbar spine	-2.83 T-score STANDARD_DEVIATION 0.67 • n=7 Participants	-2.83 T-score STANDARD_DEVIATION 0.68 • n=5 Participants	-2.84 T-score STANDARD_DEVIATION 0.68 • n=5 Participants
Bone Mineral Density T-score at Study 20030216 Baseline Total hip	-1.85 T-score STANDARD_DEVIATION 0.79 • n=7 Participants	-1.85 T-score STANDARD_DEVIATION 0.79 • n=5 Participants	-1.85 T-score STANDARD_DEVIATION 0.79 • n=5 Participants
Bone Mineral Density T-score at Study 20030216 Baseline Femoral neck	-2.11 T-score STANDARD_DEVIATION 0.71 • n=7 Participants	-2.11 T-score STANDARD_DEVIATION 0.71 • n=5 Participants	-2.11 T-score STANDARD_DEVIATION 0.71 • n=5 Participants
Any Historical Fracture at Age ≥ 55 Years	1133 participants n=7 Participants	2222 participants n=5 Participants	1089 participants n=5 Participants

PRIMARY outcome

Timeframe: 84 months

Population: All participants who received at least one dose of denosumab.

A serious adverse event (SAE) is defined as an adverse event that: • is fatal • is life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • is other significant medical hazard. Treatment-related adverse events includes only events for which the investigator indicated there was a reasonable possibility they may have been caused by study drug. The following were classified as adverse events of interest (events that are considered to be identified or potential risks of denosumab treatment): positively adjudicated osteonecrosis of the jaw, positively adjudicated atypical femoral fracture, hypocalcemia, adverse events potentially related to hypersensitivity, serious infection (including bacterial cellulitis), malignancy, cardiac disorders, vascular disorders, fracture healing complications, eczema, acute pancreatitis, and musculoskeletal pain.

Outcome measures

Measure	Placebo / Denosumab n=2206 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=2343 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Number of Participants With Adverse Events (AEs) Vascular disorders	693 participants	732 participants
Number of Participants With Adverse Events (AEs) Any adverse event (AE)	2070 participants	2173 participants
Number of Participants With Adverse Events (AEs) Serious adverse event	945 participants	1014 participants
Number of Participants With Adverse Events (AEs) Fatal adverse event	101 participants	108 participants
Number of Participants With Adverse Events (AEs) AE leading to study discontinuation	145 participants	173 participants
Number of Participants With Adverse Events (AEs) AE leading to discontinuation of denosumab	184 participants	216 participants
Number of Participants With Adverse Events (AEs) Treatment-related adverse events (TRAE)	185 participants	188 participants
Number of Participants With Adverse Events (AEs) Serious treatment-related adverse events	26 participants	28 participants
Number of Participants With Adverse Events (AEs) Fatal treatment-related adverse events	1 participants	0 participants
Number of Participants With Adverse Events (AEs) TRAE leading to study discontinuation	16 participants	9 participants
Number of Participants With Adverse Events (AEs) TRAE leading to discontinuation of denosumab	30 participants	25 participants
Number of Participants With Adverse Events (AEs) Positively adjudicated osteonecrosis of the jaw	6 participants	7 participants
Number of Participants With Adverse Events (AEs) Positively adjudicated atypical femoral fracture	1 participants	1 participants
Number of Participants With Adverse Events (AEs) Hypocalcaemia	10 participants	6 participants
Number of Participants With Adverse Events (AEs) AEs potentially related to hypersensitivity	260 participants	280 participants
Number of Participants With Adverse Events (AEs) Serious infections	161 participants	185 participants
Number of Participants With Adverse Events (AEs) Serious bacterial cellulitis	7 participants	12 participants
Number of Participants With Adverse Events (AEs) Malignancy	227 participants	237 participants
Number of Participants With Adverse Events (AEs) Cardiac disorders	449 participants	492 participants
Number of Participants With Adverse Events (AEs) Fracture healing complications	0 participants	1 participants
Number of Participants With Adverse Events (AEs) Eczema	99 participants	115 participants
Number of Participants With Adverse Events (AEs) Acute pancreatitis	4 participants	8 participants
Number of Participants With Adverse Events (AEs) Musculoskeletal pain	1125 participants	1206 participants

PRIMARY outcome

Timeframe: 84 months

Population: All participants who received at least 1 dose of denosumab

Laboratory toxicity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grade 3 indicates severe toxicity and Grade 4 indicates life-threatening toxicity.

Outcome measures

Measure	Placebo / Denosumab n=2206 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=2343 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Number of Participants With Laboratory Toxicities of Grade ≥ 3 High potassium - Grade 4	0 participants	3 participants
Number of Participants With Laboratory Toxicities of Grade ≥ 3 Low potassium - Grade 3	7 participants	7 participants
Number of Participants With Laboratory Toxicities of Grade ≥ 3 High aspartate amino transferase (AST) - Grade 3	5 participants	11 participants
Number of Participants With Laboratory Toxicities of Grade ≥ 3 High aspartate amino transferase (AST) - Grade 4	1 participants	0 participants
Number of Participants With Laboratory Toxicities of Grade ≥ 3 Low sodium - Grade 3	28 participants	25 participants
Number of Participants With Laboratory Toxicities of Grade ≥ 3 Low sodium - Grade 4	1 participants	0 participants
Number of Participants With Laboratory Toxicities of Grade ≥ 3 High potassium - Grade 3	9 participants	11 participants
Number of Participants With Laboratory Toxicities of Grade ≥ 3 Low magnesium - Grade 3	1 participants	1 participants
Number of Participants With Laboratory Toxicities of Grade ≥ 3 Low magnesium - Grade 4	0 participants	1 participants
Number of Participants With Laboratory Toxicities of Grade ≥ 3 High calcium - Grade 3	2 participants	3 participants
Number of Participants With Laboratory Toxicities of Grade ≥ 3 High calcium - Grade 4	0 participants	2 participants
Number of Participants With Laboratory Toxicities of Grade ≥ 3 High corrected calcium - Grade 3	2 participants	3 participants
Number of Participants With Laboratory Toxicities of Grade ≥ 3 High corrected calcium - Grade 4	0 participants	2 participants
Number of Participants With Laboratory Toxicities of Grade ≥ 3 Low phosphorus - Grade 3	3 participants	1 participants
Number of Participants With Laboratory Toxicities of Grade ≥ 3 High Creatinine - Grade 3	0 participants	1 participants
Number of Participants With Laboratory Toxicities of Grade ≥ 3 High alanine amino transferase (ALT) - Grade 3	8 participants	10 participants
Number of Participants With Laboratory Toxicities of Grade ≥ 3 High alanine amino transferase (ALT) - Grade 4	1 participants	0 participants
Number of Participants With Laboratory Toxicities of Grade ≥ 3 High total bilirubin - Grade 3	2 participants	3 participants
Number of Participants With Laboratory Toxicities of Grade ≥ 3 Low albumin - Grade 3	0 participants	1 participants
Number of Participants With Laboratory Toxicities of Grade ≥ 3 High glucose - Grade 3	35 participants	37 participants
Number of Participants With Laboratory Toxicities of Grade ≥ 3 High glucose - Grade 4	0 participants	1 participants
Number of Participants With Laboratory Toxicities of Grade ≥ 3 Low glucose - Grade 3	4 participants	1 participants
Number of Participants With Laboratory Toxicities of Grade ≥ 3 Low glucose - Grade 4	1 participants	1 participants
Number of Participants With Laboratory Toxicities of Grade ≥ 3 Low hemoglobin - Grade 3	6 participants	4 participants
Number of Participants With Laboratory Toxicities of Grade ≥ 3 Low platelets - Grade 3	3 participants	7 participants
Number of Participants With Laboratory Toxicities of Grade ≥ 3 Low platelets - Grade 4	2 participants	4 participants
Number of Participants With Laboratory Toxicities of Grade ≥ 3 Low white blood cells - Grade 3	5 participants	7 participants
Number of Participants With Laboratory Toxicities of Grade ≥ 3 Low white blood cells - Grade 4	0 participants	1 participants
Number of Participants With Laboratory Toxicities of Grade ≥ 3 Low lymphocytes - Grade 3	17 participants	16 participants
Number of Participants With Laboratory Toxicities of Grade ≥ 3 Low lymphocytes - Grade 4	2 participants	1 participants

PRIMARY outcome

Timeframe: Every 12 months through Month 84

Population: All participants who received at least 1 dose of denosumab

Outcome measures

Measure	Placebo / Denosumab n=2206 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=2343 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Number of Participants With Antibodies to Denosumab	1 participants	0 participants

SECONDARY outcome

Timeframe: Baseline (of extension study) and months 12, 24, 36, 60 and 84

Population: Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. "n" indicates the number of participants with available data at each time point.

Lumbar spine bone mineral density (BMD) was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Outcome measures

Measure	Placebo / Denosumab n=2089 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=2210 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Percent Change From Baseline in Lumbar Spine Bone Mineral Density by Visit Month 12 (n = 2040, 2168)	5.2 percent change Interval 5.0 to 5.3	2.0 percent change Interval 1.8 to 2.2
Percent Change From Baseline in Lumbar Spine Bone Mineral Density by Visit Month 24 (n = 1935, 2061)	7.7 percent change Interval 7.5 to 7.9	3.5 percent change Interval 3.4 to 3.7
Percent Change From Baseline in Lumbar Spine Bone Mineral Density by Visit Month 36 (n = 1497, 1607)	9.4 percent change Interval 9.1 to 9.6	4.9 percent change Interval 4.7 to 5.1
Percent Change From Baseline in Lumbar Spine Bone Mineral Density by Visit Month 60 (n = 1472, 1567)	13.0 percent change Interval 12.7 to 13.3	7.9 percent change Interval 7.6 to 8.2
Percent Change From Baseline in Lumbar Spine Bone Mineral Density by Visit Month 84 (n = 1223, 1264)	16.5 percent change Interval 16.1 to 16.9	10.8 percent change Interval 10.4 to 11.2

SECONDARY outcome

Timeframe: Baseline (of extension study) and months 12, 24, 36, 60 and 84

Population: Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. "n" indicates the number of participants with available data at each time point.

Total hip bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Outcome measures

Measure	Placebo / Denosumab n=2089 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=2210 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Percent Change From Baseline in Total Hip Bone Mineral Density by Visit Month 12 (n = 2029, 2160)	3.0 percent change Interval 2.8 to 3.1	0.8 percent change Interval 0.7 to 0.9
Percent Change From Baseline in Total Hip Bone Mineral Density by Visit Month 24 (n = 1918, 2045)	4.1 percent change Interval 4.0 to 4.2	1.4 percent change Interval 1.3 to 1.5
Percent Change From Baseline in Total Hip Bone Mineral Density by Visit Month 36 (n = 1475, 1591)	4.9 percent change Interval 4.7 to 5.0	1.8 percent change Interval 1.7 to 2.0
Percent Change From Baseline in Total Hip Bone Mineral Density by Visit Month 60 (n = 1439, 1538)	6.2 percent change Interval 6.0 to 6.4	2.6 percent change Interval 2.4 to 2.8
Percent Change From Baseline in Total Hip Bone Mineral Density by Visit Month 84 (n = 1200, 1232)	7.4 percent change Interval 7.1 to 7.6	3.4 percent change Interval 3.2 to 3.7

SECONDARY outcome

Timeframe: Baseline (of extension study) and months 12, 24, 36, 60 and 84

Population: Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. "n" indicates the number of participants with available data at each time point.

Femoral neck bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Outcome measures

Measure	Placebo / Denosumab n=2089 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=2210 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Percent Change From Baseline in Femoral Neck Bone Mineral Density by Visit Month 12 (n = 2029, 2160)	2.1 percent change Interval 1.9 to 2.3	0.8 percent change Interval 0.7 to 1.0
Percent Change From Baseline in Femoral Neck Bone Mineral Density by Visit Month 24 (n = 1918, 2045)	3.2 percent change Interval 3.1 to 3.4	1.2 percent change Interval 1.0 to 1.4
Percent Change From Baseline in Femoral Neck Bone Mineral Density by Visit Month 36 (n = 1475, 1591)	4.0 percent change Interval 3.8 to 4.3	1.7 percent change Interval 1.5 to 1.9
Percent Change From Baseline in Femoral Neck Bone Mineral Density by Visit Month 60 (n = 1439, 1538)	5.7 percent change Interval 5.4 to 5.9	2.8 percent change Interval 2.6 to 3.1
Percent Change From Baseline in Femoral Neck Bone Mineral Density by Visit Month 84 (n = 1200, 1232)	7.1 percent change Interval 6.8 to 7.4	3.8 percent change Interval 3.5 to 4.2

SECONDARY outcome

Timeframe: Baseline (of extension study) and months 12, 24, 36, 60 and 84

Population: Participants in the DXA substudy with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. "n" indicates the number of participants with available data at each time point.

1/3 radius bone mineral density was measured in a subset of participants by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center.

Outcome measures

Measure	Placebo / Denosumab n=449 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=467 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Percent Change From Baseline in 1/3 Radius Bone Mineral Density by Visit Month 12 (n = 114, 134)	0.3 percent change Interval -0.2 to 0.9	0.6 percent change Interval 0.1 to 1.2
Percent Change From Baseline in 1/3 Radius Bone Mineral Density by Visit Month 24 (n = 108, 127)	0.2 percent change Interval -0.4 to 0.9	0.2 percent change Interval -0.4 to 0.8
Percent Change From Baseline in 1/3 Radius Bone Mineral Density by Visit Month 36 (n = 73, 93)	1.3 percent change Interval 0.5 to 2.0	0.6 percent change Interval -0.1 to 1.3
Percent Change From Baseline in 1/3 Radius Bone Mineral Density by Visit Month 60 (n = 59, 84)	1.8 percent change Interval 0.9 to 2.7	1.4 percent change Interval 0.6 to 2.2
Percent Change From Baseline in 1/3 Radius Bone Mineral Density by Visit Month 84 (n = 39, 56)	2.2 percent change Interval 0.9 to 3.6	1.0 percent change Interval -0.1 to 2.2

SECONDARY outcome

Timeframe: Study 20030216 baseline and extension study months 12, 24, 36, 60 and 84

Population: Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. "n" indicates the number of participants with available data at each time point.

Lumbar spine bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. Measurements at some time points during the core study 20030216 were only taken in a subset of participants.

Outcome measures

Measure	Placebo / Denosumab n=2089 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=2210 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Percent Change From Study 20030216 Baseline in Lumbar Spine Bone Mineral Density by Visit Month 12 (n = 2030, 2148)	5.9 percent change Interval 5.6 to 6.1	11.9 percent change Interval 11.7 to 12.2
Percent Change From Study 20030216 Baseline in Lumbar Spine Bone Mineral Density by Visit Month 24 (n = 1924, 2041)	8.4 percent change Interval 8.1 to 8.7	13.7 percent change Interval 13.4 to 13.9
Percent Change From Study 20030216 Baseline in Lumbar Spine Bone Mineral Density by Visit Month 36 (n = 1487, 1589)	10.1 percent change Interval 9.8 to 10.4	15.2 percent change Interval 14.9 to 15.5
Percent Change From Study 20030216 Baseline in Lumbar Spine Bone Mineral Density by Visit Month 60 (n = 1464, 1551)	13.8 percent change Interval 13.4 to 14.1	18.4 percent change Interval 18.1 to 18.8
Percent Change From Study 20030216 Baseline in Lumbar Spine Bone Mineral Density by Visit Month 84 (n = 1216, 1251)	17.3 percent change Interval 16.8 to 17.8	21.7 percent change Interval 21.2 to 22.2

SECONDARY outcome

Timeframe: Study 20030216 baseline and extension study months 12, 24, 36, 60 and 84

Population: Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. "n" indicates the number of participants with available data at each time point.

Total hip bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. Measurements at some time points during the core study 20030216 were only taken in a subset of participants.

Outcome measures

Measure	Placebo / Denosumab n=2089 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=2210 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Percent Change From Study 20030216 Baseline in Total Hip BMD by Visit Month 12 (n = 2006, 2132)	1.7 percent change Interval 1.6 to 1.9	6.4 percent change Interval 6.3 to 6.6
Percent Change From Study 20030216 Baseline in Total Hip BMD by Visit Month 24 (n = 1895, 2017)	2.9 percent change Interval 2.7 to 3.0	7.1 percent change Interval 6.9 to 7.2
Percent Change From Study 20030216 Baseline in Total Hip BMD by Visit Month 36 (n = 1457, 1567)	3.6 percent change Interval 3.4 to 3.8	7.5 percent change Interval 7.3 to 7.7
Percent Change From Study 20030216 Baseline in Total Hip BMD by Visit Month 60 (n = 1424, 1518)	4.9 percent change Interval 4.7 to 5.2	8.4 percent change Interval 8.1 to 8.6
Percent Change From Study 20030216 Baseline in Total Hip BMD by Visit Month 84 (n = 1189, 1215)	6.1 percent change Interval 5.8 to 6.4	9.2 percent change Interval 8.9 to 9.5

SECONDARY outcome

Timeframe: Study 20030216 baseline and extension study months 12, 24, 36, 60 and 84

Population: Participants with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. "n" indicates the number of participants with available data at each time point.

Femoral neck bone mineral density was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. Measurements at some time points during the core study 20030216 were only taken in a subset of participants.

Outcome measures

Measure	Placebo / Denosumab n=2089 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=2210 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Percent Change From Study 20030216 Baseline in Femoral Neck BMD by Visit Month 12 (n = 2006, 2132)	1.4 percent change Interval 1.2 to 1.7	5.8 percent change Interval 5.6 to 6.0
Percent Change From Study 20030216 Baseline in Femoral Neck BMD by Visit Month 24 (n = 1895, 2017)	2.6 percent change Interval 2.3 to 2.8	6.2 percent change Interval 6.0 to 6.5
Percent Change From Study 20030216 Baseline in Femoral Neck BMD by Visit Month 36 (n = 1457, 1567)	3.4 percent change Interval 3.1 to 3.6	6.7 percent change Interval 6.5 to 7.0
Percent Change From Study 20030216 Baseline in Femoral Neck BMD by Visit Month 60 (n = 1424, 1518)	5.0 percent change Interval 4.7 to 5.3	7.9 percent change Interval 7.6 to 8.2
Percent Change From Study 20030216 Baseline in Femoral Neck BMD by Visit Month 84 (n = 1189, 1215)	6.4 percent change Interval 6.0 to 6.8	9.0 percent change Interval 8.6 to 9.4

SECONDARY outcome

Timeframe: Study 20030216 baseline and extension study months 12, 24, 36, 60, and 84

Population: Participants in the DXA substudy with an Extension Study baseline and at least 1 post-baseline DXA BMD measurement. "n" indicates the number of participants with available data at each time point.

1/3 radius BMD was measured by dual x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging center. Measurements at some time points during the core study 20030216 were only taken in a subset of participants.

Outcome measures

Measure	Placebo / Denosumab n=449 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=467 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Percent Change From Study 20030216 Baseline in 1/3 Radius BMD by Visit Month 12 (n = 113, 133)	-1.0 percent change Interval -1.7 to -0.3	2.6 percent change Interval 1.9 to 3.2
Percent Change From Study 20030216 Baseline in 1/3 Radius BMD by Visit Month 24 (n = 107, 127)	-1.2 percent change Interval -1.9 to -0.4	2.1 percent change Interval 1.4 to 2.8
Percent Change From Study 20030216 Baseline in 1/3 Radius BMD by Visit Month 36 (n = 73, 92)	-0.2 percent change Interval -1.1 to 0.7	2.4 percent change Interval 1.6 to 3.2
Percent Change From Study 20030216 Baseline in 1/3 Radius BMD by Visit Month 60 (n = 59, 83)	0.3 percent change Interval -0.7 to 1.3	3.3 percent change Interval 2.4 to 4.2
Percent Change From Study 20030216 Baseline in 1/3 Radius BMD by Visit Month 84 (n = 39, 56)	0.6 percent change Interval -0.8 to 2.1	2.8 percent change Interval 1.6 to 4.1

SECONDARY outcome

Timeframe: 84 months

Population: All participants enrolled in the extension study who have vertebral X-ray assessment at the extension baseline and at least 1 post-extension baseline visit.

A new vertebral fracture, assessed by lateral spine X-ray using Genant semiquantitative scoring method, was identified as an ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4, excluding any fracture associated with high trauma severity or a pathologic fracture.

Outcome measures

Measure	Placebo / Denosumab n=1991 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=2116 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Number of Participants With New Vertebral Fractures	145 participants	149 participants

SECONDARY outcome

Timeframe: 84 months

Population: All enrolled participants

Non-vertebral fractures (osteoporotic) were defined as a fracture present on a copy of radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging (MRI) confirming the fracture, and/or documented in a copy of the radiology report, surgical report, or discharge summary, excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded.

Outcome measures

Measure	Placebo / Denosumab n=2207 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=2343 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Number of Participants With Non-Vertebral Fractures	219 participants	172 participants

SECONDARY outcome

Timeframe: Baseline (of extension study), day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84

Population: Participants who received at least 1 dose of denosumab and enrolled in the bone turnover marker substudy at screening or Month 24 in Study 20060289. "n" indicates the number of participants with available data at each time point.

Bone turnover markers were collected in a subset of participants who participated in the 20030216 Bone Marker sub-study and in new participants continuing beyond month 24 who were not previously in the Bone Turnover Markers sub-study.

Outcome measures

Measure	Placebo / Denosumab n=318 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=342 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Percent Change From Baseline in C-Telopeptide 1 (CTX-1) by Visit Day 10 (n = 26, 47)	-90 percent change Interval -93.0 to -85.0	-72 percent change Interval -86.0 to -47.0
Percent Change From Baseline in C-Telopeptide 1 (CTX-1) by Visit Month 6 (n = 30, 56)	-85 percent change Interval -91.0 to -73.0	-26 percent change Interval -63.0 to 1.0
Percent Change From Baseline in C-Telopeptide 1 (CTX-1) by Visit Month 12 (n = 27, 56)	-75 percent change Interval -90.0 to -54.0	-13 percent change Interval -37.0 to 24.0
Percent Change From Baseline in C-Telopeptide 1 (CTX-1) by Visit Month 24 (n = 27, 47)	-67 percent change Interval -84.0 to -29.0	10 percent change Interval -27.0 to 55.0
Percent Change From Baseline in C-Telopeptide 1 (CTX-1) by Visit Month 36 (n = 68, 81)	-59 percent change Interval -84.0 to -28.0	2 percent change Interval -32.0 to 68.0
Percent Change From Baseline in C-Telopeptide 1 (CTX-1) by Visit Month 48 (n = 62, 75)	-58 percent change Interval -84.0 to -12.0	0 percent change Interval -46.0 to 56.0
Percent Change From Baseline in C-Telopeptide 1 (CTX-1) by Visit Month 60 (n = 59, 70)	-65 percent change Interval -90.0 to -19.0	0 percent change Interval -47.0 to 83.0
Percent Change From Baseline in C-Telopeptide 1 (CTX-1) by Visit Month 72 (n = 56, 62)	-60 percent change Interval -85.0 to -16.0	-1 percent change Interval -47.0 to 76.0
Percent Change From Baseline in C-Telopeptide 1 (CTX-1) by Visit Month 84 (n = 41, 41)	-64 percent change Interval -86.0 to -28.0	-6 percent change Interval -26.0 to 68.0

SECONDARY outcome

Timeframe: Baseline (of extension study), day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84

Population: Participants who received at least 1 dose of denosumab and enrolled in the bone turnover marker substudy at screening or Month 24 in Study 20060289. "n" indicates the number of participants with available data at each time point.

Bone turnover markers were collected in a subset of participants who participated in the 20030216 Bone Marker sub-study and in new sparticipants continuing beyond month 24 who were not previously in the Bone Turnover Markers sub-study.

Outcome measures

Measure	Placebo / Denosumab n=318 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=342 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP) by Visit Day 10 (n = 30, 51)	6 percent change Interval -5.0 to 30.0	14 percent change Interval -1.0 to 25.0
Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP) by Visit Month 6 (n = 30, 53)	-71 percent change Interval -78.0 to -62.0	-23 percent change Interval -50.0 to -2.0
Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP) by Visit Month 12 (n = 26, 56)	-67 percent change Interval -76.0 to -57.0	7 percent change Interval -15.0 to 30.0
Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP) by Visit Month 24 (n = 27, 47)	-63 percent change Interval -77.0 to -41.0	11 percent change Interval -17.0 to 42.0
Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP) by Visit Month 36 (n = 69, 83)	-57 percent change Interval -67.0 to -29.0	29 percent change Interval -6.0 to 91.0
Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP) by Visit Month 48 (n = 61, 73)	-60 percent change Interval -70.0 to -41.0	8 percent change Interval -21.0 to 49.0
Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP) by Visit Month 60 (n = 61, 71)	-54 percent change Interval -72.0 to -35.0	30 percent change Interval -6.0 to 67.0
Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP) by Visit Month 72 (n = 55, 64)	-50 percent change Interval -60.0 to -36.0	44 percent change Interval 3.0 to 103.0
Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP) by Visit Month 84 (n = 48, 50)	-59 percent change Interval -73.0 to -40.0	32 percent change Interval -4.0 to 75.0

SECONDARY outcome

Timeframe: Study 20030216 Baseline and extension study day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84

Population: Participants who received at least 1 dose of denosumab and enrolled in the bone turnover marker substudy at screening or Month 24 in Study 20060289. "n" indicates the number of participants with available data at each time point.

Bone turnover markers were collected in a subset of participants who participated in the 20030216 Bone Marker sub-study and in new participants continuing beyond month 24 who were not previously in the Bone Turnover Markers sub-study.

Outcome measures

Measure	Placebo / Denosumab n=318 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=342 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Percent Change From Study 20030216 Baseline in CTX-1 by Visit Day 10 (n = 26, 56)	-90 percent change Interval -91.0 to -78.0	-91 percent change Interval -93.0 to -86.0
Percent Change From Study 20030216 Baseline in CTX-1 by Visit Month 6 (n = 32, 72)	-83 percent change Interval -90.0 to -72.0	-77 percent change Interval -87.0 to -49.0
Percent Change From Study 20030216 Baseline in CTX-1 by Visit Month 12 (n = 27, 65)	-77 percent change Interval -91.0 to -45.0	-63 percent change Interval -87.0 to -11.0
Percent Change From Study 20030216 Baseline in CTX-1 by Visit Month 24 (n = 28, 60)	-65 percent change Interval -80.0 to -24.0	-53 percent change Interval -82.0 to 0.0
Percent Change From Study 20030216 Baseline in CTX-1 by Visit Month 36 (n = 289, 313)	-71 percent change Interval -88.0 to -40.0	-52 percent change Interval -86.0 to -4.0
Percent Change From Study 20030216 Baseline in CTX-1 by Visit Month 48 (n = 274, 290)	-70 percent change Interval -88.0 to -36.0	-61 percent change Interval -85.0 to -24.0
Percent Change From Study 20030216 Baseline in CTX-1 by Visit Month 60 (n = 268, 276)	-67 percent change Interval -88.0 to -25.0	-53 percent change Interval -86.0 to -18.0
Percent Change From Study 20030216 Baseline in CTX-1 by Visit Month 72 (n = 243, 248)	-69 percent change Interval -88.0 to -32.0	-59 percent change Interval -86.0 to -21.0
Percent Change From Study 20030216 Baseline in CTX-1 by Visit Month 84 (n = 217, 216)	-63 percent change Interval -88.0 to -19.0	-53 percent change Interval -84.0 to -12.0

SECONDARY outcome

Timeframe: Study 20030216 Baseline and extension study day 10, and months 6, 12, 24, 36, 48, 60, 72, and 84

Population: Participants who received at least 1 dose of denosumab and enrolled in the bone turnover marker substudy at screening or Month 24 in Study 20060289. "n" indicates the number of participants with available data at each time point.

Bone turnover markers were collected in a subset of participants who participated in the 20030216 Bone Marker sub-study and in new participants continuing beyond month 24 who were not previously in the Bone Turnover Markers sub-study.

Outcome measures

Measure	Placebo / Denosumab n=318 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=342 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Percent Change From Study 20030216 Baseline in P1NP by Visit Month 48 (n = 61, 73)	-67 percent change Interval -75.0 to -46.0	-63 percent change Interval -77.0 to -42.0
Percent Change From Study 20030216 Baseline in P1NP by Visit Month 60 (n = 61, 71)	-62 percent change Interval -75.0 to -42.0	-55 percent change Interval -74.0 to -30.0
Percent Change From Study 20030216 Baseline in P1NP by Visit Day 10 (n = 30, 51)	9 percent change Interval -14.0 to 34.0	-59 percent change Interval -74.0 to -22.0
Percent Change From Study 20030216 Baseline in P1NP by Visit Month 6 (n = 32, 57)	-74 percent change Interval -80.0 to -67.0	-75 percent change Interval -80.0 to -55.0
Percent Change From Study 20030216 Baseline in P1NP by Visit Month 12 (n = 26, 56)	-74 percent change Interval -79.0 to -51.0	-63 percent change Interval -76.0 to -36.0
Percent Change From Study 20030216 Baseline in P1NP by Visit Month 24 (n = 28, 51)	-67 percent change Interval -75.0 to -51.0	-56 percent change Interval -72.0 to -30.0
Percent Change From Study 20030216 Baseline in P1NP by Visit Month 36 (n = 70, 83)	-59 percent change Interval -75.0 to -37.0	-60 percent change Interval -71.0 to -40.0
Percent Change From Study 20030216 Baseline in P1NP by Visit Month 72 (n = 56, 67)	-62 percent change Interval -71.0 to -35.0	-55 percent change Interval -70.0 to -27.0
Percent Change From Study 20030216 Baseline in P1NP by Visit Month 84 (n =49, 53)	-68 percent change Interval -78.0 to -56.0	-57 percent change Interval -74.0 to -38.0

SECONDARY outcome

Timeframe: Baseline (of extension study) and day 10

Population: Participants who had a calcium corrected by albumin measurement within the Day 10 visit window up to May 31, 2008.

Outcome measures

Measure	Placebo / Denosumab n=2027 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=2154 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Percent Change From Baseline in Albumin-adjusted Serum Calcium at Day 10	-3.1 percent change Interval -6.1 to 0.0	-2.0 percent change Interval -5.1 to 1.1

SECONDARY outcome

Timeframe: Baseline (pre-dose in extension study), day 10, and Months 3, 4 and 6 (pre-dose)

Population: Participants who participated in the Study 20030216 PK substudy, for whom dosing information was not missing and for whom sampling was within 14 days of specified sampling times.

Serum concentrations of denosumab were measured by a validated conventional sandwich enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 0.8 ng/mL. Values of 0 in the table below indicate data below the lower limit of quantification.

Outcome measures

Measure	Placebo / Denosumab n=97 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=113 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Serum Denosumab Concentration Baseline (n = 97, 113)	0 ng/mL Standard Deviation 0	113 ng/mL Standard Deviation 107
Serum Denosumab Concentration Day 10 (n = 92, 106)	5890 ng/mL Standard Deviation 2010	6010 ng/mL Standard Deviation 2530
Serum Denosumab Concentration Month 3 (n = 81, 92)	1000 ng/mL Standard Deviation 560	1190 ng/mL Standard Deviation 690
Serum Denosumab Concentration Month 4 (n = 87, 104)	429 ng/mL Standard Deviation 378	554 ng/mL Standard Deviation 480
Serum Denosumab Concentration Month 6 (n = 87, 103)	20.8 ng/mL Standard Deviation 61.7	66.0 ng/mL Standard Deviation 147.2

SECONDARY outcome

Timeframe: Month 24 and month 84

Population: Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available cancellous bone volume data.

Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Cancellous (trabecular) bone volume is the percent of the total marrow cavity that is occupied by cancellous bone (both mineralized and non-mineralized) measured by quantitative histomorphometry.

Outcome measures

Measure	Placebo / Denosumab n=13 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=41 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Bone Histomorphometry: Cancellous Bone Volume Month 24 (n = 13, 25)	15.253 percentage of total bone tissue volume Standard Deviation 6.065	14.640 percentage of total bone tissue volume Standard Deviation 6.979
Bone Histomorphometry: Cancellous Bone Volume Month 84 (n = 0, 19)	NA percentage of total bone tissue volume Standard Deviation NA No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84	16.358 percentage of total bone tissue volume Standard Deviation 4.438

SECONDARY outcome

Timeframe: Month 24 and month 84

Population: Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available trabecular number data.

Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Trabecular number is the number of trabeculae present per lineal mm and is calculated as trabecular bone volume/trabecular thickness. Trabecular number is a measure of trabecular connectivity and decreases with bone loss.

Outcome measures

Measure	Placebo / Denosumab n=13 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=41 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Bone Histomorphometry: Trabecular Number Month 24 (n = 13, 25)	1.005 1/mm Standard Deviation 0.242	0.904 1/mm Standard Deviation 0.243
Bone Histomorphometry: Trabecular Number Month 24 (n = 0, 19)	NA 1/mm Standard Deviation NA No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84	1.235 1/mm Standard Deviation 0.254

SECONDARY outcome

Timeframe: Month 24 and month 84

Population: Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available trabecular separation data.

Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Trabecular separation is the mean distance between trabeculae (measured by integrated computer graphics). Trabecular separation increases with trabecular bone loss.

Outcome measures

Measure	Placebo / Denosumab n=13 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=41 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Bone Histomorphometry: Trabecular Separation Month 24 (n = 13, 25)	919.693 μm Standard Deviation 358.238	1033.416 μm Standard Deviation 352.259
Bone Histomorphometry: Trabecular Separation Month 84 (n = 0, 19)	NA μm Standard Deviation NA No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84	708.669 μm Standard Deviation 171.782

SECONDARY outcome

Timeframe: Month 24 and month 84

Population: Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available trabecular thickness data.

Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Mean trabecular thickness is a measure of trabecular structure and is calculated as the reciprocal of total bone (trabecular) surfaces. Trabecular thickness is reduced by aging and osteoporosis.

Outcome measures

Measure	Placebo / Denosumab n=13 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=41 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Bone Histomorphometry: Trabecular Thickness Month 24 (n = 13, 25)	153.878 μm Standard Deviation 51.859	156.335 μm Standard Deviation 48.567
Bone Histomorphometry: Trabecular Thickness Month 84 (n = 0, 19)	NA μm Standard Deviation NA No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84	132.965 μm Standard Deviation 28.064

SECONDARY outcome

Timeframe: Month 24 and month 84

Population: Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available cortical width data.

Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Cortical width is the average width of both inner and outer cortices.

Outcome measures

Measure	Placebo / Denosumab n=13 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=45 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Bone Histomorphometry: Cortical Width Month 24 (n = 13, 28)	622.22 μm Standard Deviation 246.70	707.69 μm Standard Deviation 237.97
Bone Histomorphometry: Cortical Width Month 84 (n = 0, 21)	NA μm Standard Deviation NA No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84	786.19 μm Standard Deviation 279.81

SECONDARY outcome

Timeframe: Month 24 and month 84

Population: Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available cancellous bone volume data.

Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Cancellous (trabecular) bone volume is the percent of the total marrow cavity that is occupied by cancellous bone (both mineralized and non-mineralized) measured by tartrate-resistant acid phosphatase (TRAP) staining histomorphometry.

Outcome measures

Measure	Placebo / Denosumab n=13 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=41 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Bone Histomorphometry: Cancellous Bone Volume by TRAP Histomorphometry Month 24 (n = 13, 25)	16.678 percentage of total bone tissue volume Standard Deviation 7.270	15.606 percentage of total bone tissue volume Standard Deviation 6.986
Bone Histomorphometry: Cancellous Bone Volume by TRAP Histomorphometry Month 84 (n = 0, 19)	NA percentage of total bone tissue volume Standard Deviation NA No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84	17.631 percentage of total bone tissue volume Standard Deviation 4.387

SECONDARY outcome

Timeframe: Month 24 and month 84

Population: Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available surface density data.

Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Surface density is calculated by total bone (trabecular) surfaces / total tissue volume.

Outcome measures

Measure	Placebo / Denosumab n=13 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=41 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Bone Histomorphometry: Surface Density Month 24 (n = 13, 25)	2.009 mm²/mm³ Standard Deviation 0.486	1.807 mm²/mm³ Standard Deviation 0.486
Bone Histomorphometry: Surface Density Month 84 (n = 0, 19)	NA mm²/mm³ Standard Deviation NA No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84	2.472 mm²/mm³ Standard Deviation 0.506

SECONDARY outcome

Timeframe: Month 24 and month 84

Population: Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoblast - osteoid interface data.

Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Osteoblast - osteoid interface is calculated as osteoblast surface / osteoid surface * 100.

Outcome measures

Measure	Placebo / Denosumab n=13 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=41 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Bone Histomorphometry: Osteoblast - Osteoid Interface Month 24 (n = 13, 25)	22.124 percentage of osteoid surface Standard Deviation 34.879	17.813 percentage of osteoid surface Standard Deviation 28.381
Bone Histomorphometry: Osteoblast - Osteoid Interface Month 84 (n = 0, 19)	NA percentage of osteoid surface Standard Deviation NA No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84	5.951 percentage of osteoid surface Standard Deviation 15.223

SECONDARY outcome

Timeframe: Month 24 and month 84

Population: Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoid surface data.

Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Osteoid surface is the percent of bone surface covered in osteoid.

Outcome measures

Measure	Placebo / Denosumab n=13 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=41 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Bone Histomorphometry: Osteoid Surface Month 24 (n = 13, 25)	0.915 percentage of total bone surface Standard Deviation 1.382	0.982 percentage of total bone surface Standard Deviation 2.489
Bone Histomorphometry: Osteoid Surface Month 84 (n = 0, 19)	NA percentage of total bone surface Standard Deviation NA No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84	0.421 percentage of total bone surface Standard Deviation 1.068

SECONDARY outcome

Timeframe: Month 24 and month 84

Population: Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoid thickness data.

Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Osteoid thickness (width) is the mean thickness of osteoid seams on cancellous surfaces. Osteoid thickness is normally <12.5 µm. Increased osteoid thickness suggests abnormal mineralization (osteomalacia).

Outcome measures

Measure	Placebo / Denosumab n=13 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=41 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Bone Histomorphometry: Osteoid Thickness Month 24 (n = 13, 25)	5.139 μm Standard Deviation 3.261	4.548 μm Standard Deviation 4.973
Bone Histomorphometry: Osteoid Thickness Month 84 (n = 0, 19)	NA μm Standard Deviation NA No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84	4.108 μm Standard Deviation 3.476

SECONDARY outcome

Timeframe: Month 24 and month 84

Population: Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available wall thickness data.

Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. Wall thickness is the average thickness of trabecular bone structural units (BSU) and is used to assess the overall balance between resorption and formation.

Outcome measures

Measure	Placebo / Denosumab n=13 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=41 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Bone Histomorphometry: Wall Thickness Month 24 (n = 13, 25)	43.11 μm Standard Deviation 6.08	49.74 μm Standard Deviation 10.51
Bone Histomorphometry: Wall Thickness Month 84 (n = 0, 19)	NA μm Standard Deviation NA No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84	39.59 μm Standard Deviation 7.49

SECONDARY outcome

Timeframe: Month 24 and month 84

Population: Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available eroded surface/bone surface data.

Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.

Eroded surface/bone surface is the percentage of bone surface occupied by eroded (resorption) cavities (Howships lacunae), with or without osteoclasts.

Outcome measures

Measure	Placebo / Denosumab n=13 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=41 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Bone Histomorphometry: Eroded Surface/Bone Surface Month 24 (n = 13, 25)	0.414 percentage of bone surface Standard Deviation 0.701	0.328 percentage of bone surface Standard Deviation 0.613
Bone Histomorphometry: Eroded Surface/Bone Surface Month 84 (n = 0, 19)	NA percentage of bone surface Standard Deviation NA No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84	0.511 percentage of bone surface Standard Deviation 0.579

SECONDARY outcome

Timeframe: Month 24 and month 84

Population: Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoclast number data.

Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.

Osteoclast number was measured by quantitative histomorphometry and is expressed per mm of bone.

Outcome measures

Measure	Placebo / Denosumab n=13 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=41 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Bone Histomorphometry: Osteoclast Number - Length Based Month 24 (n = 13, 25)	0.086 1/mm Standard Deviation 0.119	0.107 1/mm Standard Deviation 0.198
Bone Histomorphometry: Osteoclast Number - Length Based Month 84 (n = 0, 19)	NA 1/mm Standard Deviation NA No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84	0.074 1/mm Standard Deviation 0.101

SECONDARY outcome

Timeframe: Month 24 and month 84

Population: Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoclast number data.

Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.

Osteoclast number was measured by quantitative histomorphometry and is expressed per 100 mm of bone surface area.

Outcome measures

Measure	Placebo / Denosumab n=13 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=41 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Bone Histomorphometry: Osteoclast Number - Surface Based Month 84 (n = 0, 19)	NA 1/100 mm Standard Deviation NA No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84	7.4 1/100 mm Standard Deviation 10.1
Bone Histomorphometry: Osteoclast Number - Surface Based Month 24 (n = 13, 25)	8.6 1/100 mm Standard Deviation 11.9	10.7 1/100 mm Standard Deviation 19.8

SECONDARY outcome

Timeframe: Month 24 and month 84

Population: Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoclast number data.

Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.

Osteoclast number was measured using TRAP staining and is expressed per mm of bone.

Outcome measures

Measure	Placebo / Denosumab n=13 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=41 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Bone Histomorphometry: Osteoclast Number by TRAP - Length Based Month 24 (n = 13, 25)	0.096 1/mm Standard Deviation 0.134	0.110 1/mm Standard Deviation 0.185
Bone Histomorphometry: Osteoclast Number by TRAP - Length Based Month 84 (n = 0, 19)	NA 1/mm Standard Deviation NA No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84	0.077 1/mm Standard Deviation 0.107

SECONDARY outcome

Timeframe: Month 24 and month 84

Population: Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoclast number data.

Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.

Osteoclast number was measured using TRAP staining and is expressed per 100 mm of bone surface.

Da

Outcome measures

Measure	Placebo / Denosumab n=13 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=41 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Bone Histomorphometry: Osteoclast Number by TRAP - Surface Based Month 24 (n = 13, 25)	9.6 1/100 mm Standard Deviation 13.4	11.0 1/100 mm Standard Deviation 18.5
Bone Histomorphometry: Osteoclast Number by TRAP - Surface Based Month 84 (n = 0, 19)	NA 1/100 mm Standard Deviation NA No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84	7.7 1/100 mm Standard Deviation 10.7

SECONDARY outcome

Timeframe: Month 24 and month 84

Population: Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available single-label surface data.

Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.

A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. A single label is deposited if formation either started or ended during the interval between the uses of the two courses of tetracycline administration. Single-label surface is expressed as a percentage of total bone surface.

Outcome measures

Measure	Placebo / Denosumab n=5 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=20 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Bone Histomorphometry: Single-label Surface Month 24 (n = 5, 10)	0.304 percentage of bone surface Standard Deviation 0.302	0.643 percentage of bone surface Standard Deviation 0.661
Bone Histomorphometry: Single-label Surface Month 84 (n = 0, 10)	NA percentage of bone surface Standard Deviation NA No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84	0.611 percentage of bone surface Standard Deviation 0.726

SECONDARY outcome

Timeframe: Month 24 and month 84

Population: Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available double-label surface data.

Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.

A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. The presence of double labels indicates that normal bone mineralization was actively occurring over the entire labeling interval. Double-label surface is expressed as a percentage of total bone surface.

Outcome measures

Measure	Placebo / Denosumab n=5 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=20 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Bone Histomorphometry: Double-label Surface Month 24 (n = 5, 10)	0.258 percentage of bone surface Standard Deviation 0.207	0.356 percentage of bone surface Standard Deviation 0.295
Bone Histomorphometry: Double-label Surface Month 84 (n = 0, 10)	NA percentage of bone surface Standard Deviation NA No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84	0.106 percentage of bone surface Standard Deviation 0.237

SECONDARY outcome

Timeframe: Month 24 and month 84

Population: Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available mineralizing surface data.

Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.

A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. Total mineralizing surfaces (MS) include all double and half of single-labeled surfaces. MS is expressed as a percentage of total bone surface.

Outcome measures

Measure	Placebo / Denosumab n=5 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=20 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Bone Histomorphometry: Mineralizing Surface Month 24 (n = 5, 10)	0.406 percentage of bone surface Standard Deviation 0.323	0.681 percentage of bone surface Standard Deviation 0.453
Bone Histomorphometry: Mineralizing Surface Month 84 (n = 0, 10)	NA percentage of bone surface Standard Deviation NA No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84	0.412 percentage of bone surface Standard Deviation 0.458

SECONDARY outcome

Timeframe: Month 24 and month 84

Population: Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available mineral apposition rate data.

Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.

A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. The mineral apposition rate (MAR) is the avarage rate at which new bone mineral is being added on any actively forming surface. MAR is calculated as the average distance between visible labels, divided by the labeling interval.

Outcome measures

Measure	Placebo / Denosumab n=5 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=20 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Bone Histomorphometry: Mineral Apposition Rate Month 24 (n = 5, 10)	0.616 μm/day Standard Deviation 0.219	0.722 μm/day Standard Deviation 0.573
Bone Histomorphometry: Mineral Apposition Rate Month 84 (n = 0, 10)	NA μm/day Standard Deviation NA No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84	0.394 μm/day Standard Deviation 0.233

SECONDARY outcome

Timeframe: Month 24 and month 84

Population: Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available adjusted apposition rate data.

Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.

A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. The mineral apposition rate (MAR) is the average rate at which new bone mineral is being added on any actively forming surface. Adjusted MAR is calculated as: (average distance between visible labels / labeling interval) * (total mineralizing surface/total bone surface).

Outcome measures

Measure	Placebo / Denosumab n=5 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=19 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Bone Histomorphometry: Adjusted Apposition Rate Month 24 (n = 5, 9)	0.394 μm/day Standard Deviation 0.471	0.517 μm/day Standard Deviation 0.537
Bone Histomorphometry: Adjusted Apposition Rate Month 84 (n = 0, 10)	NA μm/day Standard Deviation NA No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84	0.818 μm/day Standard Deviation 1.207

SECONDARY outcome

Timeframe: Month 24 and month 84

Population: Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available bone formation rate data.

Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.

A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. Bone formation rate - surface based is the calculated rate at which cancellous bone surface is being replaced annually, derived from the Mineral Appositional Rate * 365 * (relative mineralizing surface / total bone surface).

Outcome measures

Measure	Placebo / Denosumab n=5 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=20 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Bone Histomorphometry: Bone Formation Rate - Surface Based Month 24 (n = 5, 10)	0.898 μm³/μm²/year Standard Deviation 0.706	2.153 μm³/μm²/year Standard Deviation 2.468
Bone Histomorphometry: Bone Formation Rate - Surface Based Month 84 (n = 0, 10)	NA μm³/μm²/year Standard Deviation NA No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84	0.691 μm³/μm²/year Standard Deviation 0.868

SECONDARY outcome

Timeframe: Month 24 and month 84

Population: Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available bone formation rate data.

Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.

A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. Bone formation rate - volume based is the calculated rate at which cancellous bone volume is being replaced annually, derived from the Mineral Appositional Rate * 365 * (relative mineralizing surface / total bone volume).

Outcome measures

Measure	Placebo / Denosumab n=5 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=20 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Bone Histomorphometry: Bone Formation Rate - Volume Based Month 24 (n = 5, 10)	1.454 percent of bone volume per year Standard Deviation 1.265	3.162 percent of bone volume per year Standard Deviation 3.773
Bone Histomorphometry: Bone Formation Rate - Volume Based Month 84 (n = 0, 10)	NA percent of bone volume per year Standard Deviation NA No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84	1.071 percent of bone volume per year Standard Deviation 1.308

SECONDARY outcome

Timeframe: Month 24 and month 84

Population: Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available formation period data.

Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.

A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. Formation period (FP) is the mean time required to rebuild a new bone structural unit or osteon from the cement line back to the bone surface at a single location, and is given by wall width / adjusted apposition rate.

Outcome measures

Measure	Placebo / Denosumab n=5 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=20 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Bone Histomorphometry: Formation Period Month 24 (n = 5, 10)	593.5 days Standard Deviation 996.8	287.3 days Standard Deviation 391.5
Bone Histomorphometry: Formation Period Month 84 (n = 0, 10)	NA days Standard Deviation NA No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84	229.7 days Standard Deviation 512.0

SECONDARY outcome

Timeframe: Month 24 and month 84

Population: Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available activation frequency data.

Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.

A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken. The average time that it takes for a new remodeling cycle to begin on any point on a cancellous surface is called the activation frequency. Activation frequency is calculated as the bone formation rate / wall width.

Outcome measures

Measure	Placebo / Denosumab n=5 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=20 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Bone Histomorphometry: Activation Frequency Month 24 (n = 5, 10)	0.022 /year Standard Deviation 0.019	0.045 /year Standard Deviation 0.049
Bone Histomorphometry: Activation Frequency Month 84 (n = 0, 10)	NA /year Standard Deviation NA No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84	0.014 /year Standard Deviation 0.024

SECONDARY outcome

Timeframe: Month 24 and month 84

Population: Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available osteoid volume data.

Bone biopsy samples were prepared according to standard procedures for bone histomorphometry.

Osteoid volume is the percentage of a given volume of bone tissue that consists of unmineralized bone (osteoid).

Outcome measures

Measure	Placebo / Denosumab n=13 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=41 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Bone Histomorphometry: Osteoid Volume Month 24 (n = 13, 25)	0.108 percentage of total bone tissue Standard Deviation 0.193	0.146 percentage of total bone tissue Standard Deviation 0.382
Bone Histomorphometry: Osteoid Volume Month 84 (n = 0, 19)	NA percentage of total bone tissue Standard Deviation NA No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84	0.048 percentage of total bone tissue Standard Deviation 0.133

SECONDARY outcome

Timeframe: Month 24 and month 84

Population: Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, had at least 1 bone biopsy evaluable for histomorphometry at extension month 24 or extension month 84 and with available mineralization lag time data.

Bone biopsy samples were prepared according to standard procedures for bone histomorphometry. A double tetracycline labeling procedure was used to allow visualization and quantification of sites of new bone formation. Tetracycline was given for two periods of 3 days separated by 14 days where no tetracycline was taken.

Mineralization lag time is the average time interval between osteoid formation and its subsequent mineralization and is calculated by dividing the osteoid width by the apposition rate.

Outcome measures

Measure	Placebo / Denosumab n=5 Participants Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=20 Participants Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Bone Histomorphometry: Mineralization Lag Time Month 24 (n = 5, 10)	84.9 days Standard Deviation 136.8	54.3 days Standard Deviation 76.1
Bone Histomorphometry: Mineralization Lag Time Month 84 (n = 0, 10)	NA days Standard Deviation NA No participants in this arm had a bone biopsy evaluable for histomorphometry at month 84	52.3 days Standard Deviation 114.5

SECONDARY outcome

Timeframe: Month 24

Population: Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, and had at least 1 bone biopsy evaluable for histology at extension month 24.

Bone biopsy samples were prepared according to standard procedures for bone histology to determine if there were any histological abnormalities in the bone. Results are reported for the number of biopsies with normal bone micro-architecture: normal lamellar bone, normal mineralization, and osteoid, and biopsies with abnormal bone histology: osteomalacia, marrow fibrosis, or woven bone.

Outcome measures

Measure	Placebo / Denosumab n=13 biopsies Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=28 biopsies Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Bone Histology at Month 24 Normal lamellar bone	13 biopsies	28 biopsies
Bone Histology at Month 24 Normal mineralization	13 biopsies	28 biopsies
Bone Histology at Month 24 Osteoid	13 biopsies	23 biopsies
Bone Histology at Month 24 Osteomalacia	0 biopsies	0 biopsies
Bone Histology at Month 24 Marrow fibrosis	0 biopsies	0 biopsies
Bone Histology at Month 24 Woven bone	0 biopsies	0 biopsies

SECONDARY outcome

Timeframe: Month 84

Population: Participants who enrolled in the bone biopsy substudy, received at least 1 dose of denosumab during the extension study, and had at least 1 bone biopsy evaluable for histology at extension month 84.

Bone biopsy samples were prepared according to standard procedures for bone histology to determine if there were any histological abnormalities in the bone. Results are reported for the number of biopsies with normal bone micro-architecture: normal lamellar bone, normal mineralization, and osteoid, and biopsies with abnormal bone histology: osteomalacia, marrow fibrosis, or woven bone.

Outcome measures

Measure	Placebo / Denosumab Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.	Denosumab / Denosumab n=22 biopsies Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
Bone Histology at Month 84 Normal lamellar bone	—	22 biopsies
Bone Histology at Month 84 Normal mineralization	—	22 biopsies
Bone Histology at Month 84 Osteoid	—	18 biopsies
Bone Histology at Month 84 Osteomalacia	—	0 biopsies
Bone Histology at Month 84 Marrow fibrosis	—	0 biopsies
Bone Histology at Month 84 Woven bone	—	0 biopsies

Adverse Events

Placebo/ Denosumab 60 mg Q6M

Serious events: 945 serious events

Other events: 1809 other events

Deaths: 0 deaths

Denosumab/ Denosumab 60 mg Q6M

Serious events: 1014 serious events

Other events: 1920 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo/ Denosumab 60 mg Q6M n=2206 participants at risk Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years.	Denosumab/ Denosumab 60 mg Q6M n=2343 participants at risk Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years (total of 10 years treatment).
Nervous system disorders Parkinsonism	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Partial seizures	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Polyneuropathy	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Presyncope	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastrointestinal mucosal disorder	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastrointestinal obstruction	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastrointestinal stenosis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Pseudoradicular syndrome	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Pyramidal tract syndrome	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Radicular syndrome	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Anaemia	0.50% 11/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.47% 11/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Bone marrow oedema	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Haemorrhagic disorder	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Iron deficiency anaemia	0.14% 3/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Leukopenia	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Lymphadenitis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Lymphadenopathy	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Microcytic anaemia	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Neutropenia	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Pancytopenia	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Polycythaemia	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Splenomegaly	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Thrombocytopenia	0.14% 3/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Blood and lymphatic system disorders Thrombocytosis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Acute coronary syndrome	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Acute myocardial infarction	0.36% 8/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.77% 18/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Adams-Stokes syndrome	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Angina pectoris	0.77% 17/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.81% 19/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Angina unstable	0.32% 7/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.51% 12/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Aortic valve disease	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Aortic valve incompetence	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Aortic valve stenosis	0.18% 4/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Arrhythmia	0.14% 3/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Arrhythmia supraventricular	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Arteriosclerosis coronary artery	0.14% 3/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Atrial fibrillation	2.3% 50/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.7% 40/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Atrial flutter	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Atrioventricular block	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Atrioventricular block complete	0.23% 5/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Atrioventricular block second degree	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Bradycardia	0.23% 5/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Bundle branch block left	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiac arrest	0.18% 4/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiac disorder	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiac failure	0.68% 15/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.90% 21/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiac failure acute	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiac failure chronic	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiac failure congestive	0.45% 10/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.38% 9/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiac fibrillation	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiac valve disease	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiac valve sclerosis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardio-respiratory arrest	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiogenic shock	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiomyopathy	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiopulmonary failure	0.18% 4/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Cardiovascular insufficiency	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Chronic right ventricular failure	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Coronary artery disease	0.41% 9/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.73% 17/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Coronary artery insufficiency	0.14% 3/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Coronary artery occlusion	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Coronary artery stenosis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.26% 6/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Extrasystoles	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Heart valve calcification	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Heart valve incompetence	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Hypertensive heart disease	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Ischaemic cardiomyopathy	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Left atrial dilatation	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Left ventricular failure	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Mitral valve disease	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Mitral valve disease mixed	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Mitral valve incompetence	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Myocardial infarction	0.95% 21/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.0% 24/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Myocardial ischaemia	0.18% 4/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.55% 13/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Palpitations	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Pericardial effusion	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Pericardial haemorrhage	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Pericarditis	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Right ventricular failure	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Sinoatrial block	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Sinus arrest	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Sinus bradycardia	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Sinus node dysfunction	0.27% 6/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.43% 10/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Supraventricular extrasystoles	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Supraventricular tachyarrhythmia	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Supraventricular tachycardia	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Tachyarrhythmia	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Tachycardia	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Tachycardia induced cardiomyopathy	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Tricuspid valve disease	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Ventricular arrhythmia	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Ventricular extrasystoles	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Ventricular fibrillation	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Cardiac disorders Ventricular tachycardia	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Congenital, familial and genetic disorders Cancer gene carrier	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Congenital, familial and genetic disorders Congenital ureteric anomaly	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Congenital, familial and genetic disorders Corneal dystrophy	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Congenital, familial and genetic disorders Muscular dystrophy	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Ear and labyrinth disorders Deafness unilateral	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Ear and labyrinth disorders Hypoacusis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Ear and labyrinth disorders Meniere's disease	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Ear and labyrinth disorders Otosclerosis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Ear and labyrinth disorders Vertigo	0.63% 14/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.34% 8/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Ear and labyrinth disorders Vertigo positional	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Ear and labyrinth disorders Vestibular disorder	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Endocrine disorders Adrenal mass	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Endocrine disorders Basedow's disease	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Endocrine disorders Goitre	0.27% 6/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.21% 5/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Endocrine disorders Hyperthyroidism	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Endocrine disorders Thyroiditis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Endocrine disorders Toxic nodular goitre	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Blepharochalasis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Blindness	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Blindness unilateral	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Cataract	0.77% 17/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.64% 15/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Cataract diabetic	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Detachment of macular retinal pigment epithelium	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Diplopia	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Ectropion	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Eye haemorrhage	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Glaucoma	0.14% 3/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Iridocyclitis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Keratopathy	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Macular fibrosis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Maculopathy	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Open angle glaucoma	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Retinal detachment	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Retinal haemorrhage	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Retinal tear	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Retinal vascular thrombosis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Ulcerative keratitis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Visual impairment	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Vitreous haemorrhage	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal adhesions	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal distension	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal hernia	0.18% 4/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal hernia obstructive	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal pain	0.45% 10/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.34% 8/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal pain upper	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Abdominal rigidity	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Acquired oesophageal web	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Anal haemorrhage	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Anal prolapse	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Anal sphincter atony	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Chronic gastritis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Coeliac disease	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Colitis	0.14% 3/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Colitis ischaemic	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Colitis microscopic	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Colitis ulcerative	0.14% 3/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Constipation	0.36% 8/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.26% 6/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Crohn's disease	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Diaphragmatic hernia	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Diarrhoea	0.41% 9/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Diverticular perforation	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Diverticulum	0.14% 3/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Diverticulum intestinal	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.26% 6/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Diverticulum oesophageal	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Duodenal stenosis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Duodenal ulcer	0.23% 5/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Duodenal ulcer perforation	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Duodenitis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Dyspepsia	0.14% 3/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Dysphagia	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Enteritis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Enterocolitis haemorrhagic	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Epigastric discomfort	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Faecal incontinence	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Faeces discoloured	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Femoral hernia	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastric ulcer	0.27% 6/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastritis	0.18% 4/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.38% 9/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastritis erosive	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastroduodenal ulcer	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.27% 6/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastrointestinal inflammation	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastrointestinal motility disorder	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.14% 3/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Haematemesis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Haematochezia	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Haemorrhoids	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Hernial eventration	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Hiatus hernia	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Ileus	0.32% 7/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Inguinal hernia	0.63% 14/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.30% 7/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Intestinal angina	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Intestinal fistula	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Intestinal haemorrhage	0.18% 4/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Intestinal ischaemia	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Intestinal obstruction	0.23% 5/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Intestinal perforation	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Intestinal strangulation	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Irritable bowel syndrome	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Large intestinal haemorrhage	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Large intestinal stenosis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Large intestine polyp	0.18% 4/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.21% 5/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Malabsorption	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Mechanical ileus	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Melaena	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Mesenteric artery embolism	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Nausea	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Oesophageal polyp	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Oesophagitis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Pancreatic cyst	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Pancreatic necrosis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Pancreatitis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Pancreatitis acute	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Pancreatitis chronic	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Pancreatitis necrotising	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Peptic ulcer	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Periodontal disease	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Peritoneal perforation	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Pharyngo-oesophageal diverticulum	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Rectal haemorrhage	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Rectal polyp	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Rectal prolapse	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Retroperitoneal haematoma	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Small intestinal obstruction	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Stomatitis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Subileus	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Tongue oedema	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Toothache	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Umbilical hernia	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Volvulus	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Volvulus of small bowel	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Vomiting	0.18% 4/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Adverse drug reaction	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Asthenia	0.14% 3/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Chest pain	0.41% 9/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.34% 8/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Chronic fatigue syndrome	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Death	0.73% 16/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.55% 13/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Device dislocation	0.14% 3/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.21% 5/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Device failure	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Device malfunction	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Face oedema	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Fatigue	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Foreign body reaction	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Gait disturbance	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders General physical health deterioration	0.18% 4/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Hernia	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Incarcerated hernia	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Inflammation	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Ischaemic ulcer	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Malaise	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Medical device complication	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Multi-organ failure	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Nodule	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Non-cardiac chest pain	0.32% 7/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.21% 5/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Oedema peripheral	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Peripheral swelling	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Polyp	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Pyrexia	0.18% 4/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.21% 5/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Sudden cardiac death	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Sudden death	0.18% 4/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Ulcer haemorrhage	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Bile duct obstruction	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Bile duct stenosis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Bile duct stone	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Biliary cirrhosis primary	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Biliary colic	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.21% 5/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Cholangitis	0.18% 4/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Cholecystitis	0.27% 6/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Cholecystitis acute	0.18% 4/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Cholelithiasis	1.00% 22/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.3% 30/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Gallbladder necrosis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Gallbladder oedema	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Gallbladder polyp	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Hepatic cyst	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Hepatic failure	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Jaundice	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Jaundice cholestatic	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Hepatobiliary disorders Liver disorder	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Immune system disorders Anaphylactic reaction	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Immune system disorders Autoimmune disorder	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Immune system disorders Drug hypersensitivity	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Immune system disorders Hypersensitivity	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Immune system disorders Sarcoidosis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Abdominal abscess	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Abdominal sepsis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Abscess	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Abscess limb	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Abscess neck	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Appendiceal abscess	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Appendicitis	0.18% 4/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.21% 5/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Appendicitis perforated	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Arthritis bacterial	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Arthritis infective	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Atypical pneumonia	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Bacteraemia	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Bacterial infection	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Bacterial pyelonephritis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Bronchitis	0.36% 8/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.30% 7/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Bronchitis fungal	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Bronchopneumonia	0.27% 6/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.26% 6/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Cellulitis	0.14% 3/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Cholecystitis infective	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Chronic sinusitis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Chronic tonsillitis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Clostridium difficile infection	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Cystitis	0.27% 6/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.21% 5/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Dengue fever	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Device related infection	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Diverticulitis	0.50% 11/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.43% 10/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Ear infection	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Endocarditis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Enterocolitis bacterial	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Erysipelas	0.18% 4/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.38% 9/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Gangrene	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Gastroenteritis	0.41% 9/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.38% 9/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Gastroenteritis viral	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Gastrointestinal infection	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations H1N1 influenza	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Haemophilus infection	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Helicobacter gastritis	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Hepatic cyst infection	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Hepatitis C	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Herpes zoster	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Infected skin ulcer	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Infection	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Influenza	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Klebsiella bacteraemia	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Klebsiella infection	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Laryngitis	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Listeriosis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Liver abscess	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Lobar pneumonia	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Localised infection	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Lower respiratory tract infection	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.26% 6/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Lung infection	0.14% 3/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Lymph node tuberculosis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Meningitis aseptic	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Meningitis viral	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Mycobacterium avium complex infection	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Necrotising fasciitis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Neutropenic sepsis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Onychomycosis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Osteomyelitis	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Otitis media	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Parotitis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Peritonitis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pneumonia	2.0% 44/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.0% 48/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pneumonia bacterial	0.14% 3/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pneumonia haemophilus	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pneumonia influenzal	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pneumonia pneumococcal	0.14% 3/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pneumonia pseudomonal	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pneumonia staphylococcal	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pneumonia streptococcal	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Post procedural infection	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Postoperative wound infection	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pseudomembranous colitis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pulmonary tuberculosis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pyelonephritis	0.23% 5/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pyelonephritis acute	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pyelonephritis chronic	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Respiratory tract infection	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Salmonellosis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Salpingitis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Salpingo-oophoritis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Sepsis	0.27% 6/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.64% 15/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Septic shock	0.23% 5/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.21% 5/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Sinusitis	0.14% 3/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Skin infection	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Small intestine gangrene	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Soft tissue infection	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Staphylococcal sepsis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Stenotrophomonas infection	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Subcutaneous abscess	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Subdural empyema	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Tick-borne viral encephalitis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Tonsillitis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Tooth infection	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Tracheitis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Tracheobronchitis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Tuberculosis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Tuberculosis of peripheral lymph nodes	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Upper respiratory tract infection	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Urinary tract infection	0.59% 13/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.47% 11/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Urosepsis	0.27% 6/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Vaginal infection	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Vestibular neuronitis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Viral infection	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Wound infection	0.14% 3/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Acetabulum fracture	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Animal bite	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Bone fissure	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Brain contusion	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Carbon monoxide poisoning	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Cartilage injury	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Cataract traumatic	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Clavicle fracture	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Concussion	0.32% 7/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.34% 8/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Contusion	0.18% 4/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Coronary artery restenosis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Craniocerebral injury	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Dislocation of vertebra	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Eye penetration	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.38% 9/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Fall	0.59% 13/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.68% 16/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Femoral neck fracture	0.73% 16/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.64% 15/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Femur fracture	0.73% 16/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.51% 12/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Fibula fracture	0.63% 14/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.47% 11/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Foot fracture	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Fractured sacrum	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Gastrointestinal stoma complication	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Graft complication	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Head injury	0.18% 4/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.26% 6/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Hip fracture	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Humerus fracture	0.59% 13/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.21% 5/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Ilium fracture	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Incisional hernia	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Injury corneal	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Joint dislocation	0.32% 7/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.26% 6/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Joint injury	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Laceration	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Ligament injury	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Ligament rupture	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Ligament sprain	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Limb crushing injury	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.18% 4/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Meniscus injury	0.23% 5/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Multiple injuries	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Muscle rupture	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Overdose	0.14% 3/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Patella fracture	0.23% 5/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.21% 5/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Perineal injury	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Pneumothorax traumatic	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Post procedural haematoma	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Postoperative hernia	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Postoperative ileus	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Procedural hypotension	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Procedural pain	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Pubis fracture	0.14% 3/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.21% 5/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Radiation mucositis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Radius fracture	1.1% 25/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.94% 22/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Rib fracture	0.32% 7/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Road traffic accident	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Scar	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Shunt malfunction	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Skeletal injury	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Skin abrasion	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Skull fracture	0.23% 5/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Soft tissue injury	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Subdural haematoma	0.36% 8/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Subdural haemorrhage	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Tendon rupture	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Thermal burn	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.38% 9/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Tibia fracture	0.77% 17/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.51% 12/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Toxicity to various agents	0.18% 4/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Transplant dysfunction	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Ulna fracture	0.41% 9/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.38% 9/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Ulnar nerve injury	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Wound	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Wrist fracture	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Antinuclear antibody positive	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood pressure increased	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Blood pressure orthostatic	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Carcinoembryonic antigen increased	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Hepatic enzyme increased	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Investigation	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Occult blood positive	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Protein total decreased	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Troponin increased	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Investigations Weight decreased	0.14% 3/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Cachexia	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Dehydration	0.27% 6/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.30% 7/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Diabetes mellitus	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Electrolyte imbalance	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypercalcaemia	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypercholesterolaemia	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hyperglycaemia	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hyperkalaemia	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypocalcaemia	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypokalaemia	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hyponatraemia	0.18% 4/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Metabolic acidosis	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Vitamin B12 deficiency	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Acquired claw toe	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Arthralgia	0.45% 10/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.64% 15/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Arthritis	0.27% 6/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Arthropathy	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Back pain	0.73% 16/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.43% 10/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Bone disorder	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Bone loss	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Bone pain	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Chondrocalcinosis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Chondropathy	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Compartment syndrome	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Fibromyalgia	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Fistula	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Foot deformity	0.18% 4/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.30% 7/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Fracture pain	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.54% 12/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.30% 7/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Joint swelling	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Kyphosis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.18% 4/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.21% 5/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Mobility decreased	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Monarthritis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Morphoea	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Muscle disorder	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Muscular weakness	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.18% 4/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Myopathy	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Neck pain	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Nodal osteoarthritis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Osteoarthritis	3.6% 79/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.2% 99/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Osteoarthropathy	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.23% 5/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.14% 3/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.26% 6/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Osteoporosis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Pain in extremity	0.23% 5/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Pain in jaw	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Plica syndrome	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Pseudarthrosis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.18% 4/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Sacroiliitis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Seronegative arthritis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Sjogren's syndrome	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.63% 14/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.94% 22/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.18% 4/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Spinal pain	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Spondyloarthropathy	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Synovial cyst	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Synovial disorder	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Synovitis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.18% 4/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.21% 5/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenoma benign	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenosquamous cell lung cancer	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal adenoma	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal neoplasm	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal cancer	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.73% 16/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.60% 14/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign breast neoplasm	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign gastrointestinal neoplasm	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign hepatic neoplasm	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign lung neoplasm	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of bladder	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of skin	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of thyroid gland	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign pancreatic neoplasm	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign salivary gland neoplasm	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign vulval neoplasm	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain cancer metastatic	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm malignant	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.95% 21/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.0% 24/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer recurrent	0.14% 3/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast neoplasm	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoma in situ of skin	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Central nervous system lymphoma	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholesteatoma	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.32% 7/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.51% 12/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neoplasm	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenocarcinoma	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Dermatofibrosarcoma protuberans	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma stage IV	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Follicular thyroid cancer	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder cancer	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.21% 5/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal stromal tumour	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal tract adenoma	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gingival cancer	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hairy cell leukaemia	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive breast carcinoma	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.45% 10/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive papillary breast carcinoma	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal papilloma	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyosarcoma	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lentigo maligna	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip neoplasm malignant stage unspecified	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.18% 4/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified recurrent	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.50% 11/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.55% 13/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma stage 0	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphocytic leukaemia	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.14% 3/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.21% 5/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of spinal cord	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant peritoneal neoplasm	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant urinary tract neoplasm	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mantle cell lymphoma	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesothelioma	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.14% 3/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to peritoneum	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastasis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic carcinoma of the bladder	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic gastric cancer	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.14% 3/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic renal cell carcinoma	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic squamous cell carcinoma	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Monoclonal gammopathy	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Muscle neoplasm	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myeloproliferative disorder	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroma	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nodular fasciitis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma stage IV	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal squamous cell carcinoma	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oral neoplasm	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian adenoma	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer metastatic	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer stage III	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian epithelial cancer	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian fibroma	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.27% 6/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.21% 5/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neoplasm	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumour benign	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pelvic neoplasm	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Phyllodes tumour	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.14% 3/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasmacytoma	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Polycythaemia vera	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.23% 5/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenoma	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectosigmoid cancer	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.14% 3/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the oral cavity	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid adenoma	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue neoplasm malignant stage unspecified	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ureteric cancer	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.27% 6/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vulval cancer	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Acoustic neuritis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Akinesia	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Amnesia	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Amyotrophic lateral sclerosis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Aphasia	0.14% 3/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Ataxia	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Carotid artery occlusion	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Carotid artery stenosis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Carotid artery thrombosis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Carpal tunnel syndrome	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.21% 5/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cauda equina syndrome	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cerebellar haemorrhage	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cerebellar infarction	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cerebral arteriosclerosis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cerebral artery embolism	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cerebral atrophy	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cerebral haemorrhage	0.23% 5/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cerebral infarction	0.23% 5/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.73% 17/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cerebral ischaemia	0.27% 6/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.26% 6/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cerebral microangiopathy	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cerebral thrombosis	0.36% 8/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.34% 8/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cerebrovascular accident	1.00% 22/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.2% 29/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cerebrovascular disorder	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cerebrovascular insufficiency	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cervicogenic headache	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cognitive disorder	0.14% 3/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Coma	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Cubital tunnel syndrome	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Dementia	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Dementia Alzheimer's type	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.21% 5/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Diabetic hyperosmolar coma	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Diabetic neuropathy	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Dizziness	0.23% 5/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.21% 5/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Dysaesthesia	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Embolic stroke	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Encephalopathy	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Epilepsy	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Extrapyramidal disorder	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Facial paresis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Haemorrhage intracranial	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Haemorrhagic stroke	0.14% 3/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Headache	0.18% 4/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Hemiparesis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Hypertensive encephalopathy	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Hypoaesthesia	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Hypotonia	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Intercostal neuralgia	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Intracranial aneurysm	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Ischaemic cerebral infarction	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Ischaemic stroke	0.50% 11/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.38% 9/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Lacunar infarction	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Loss of consciousness	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Lumbar radiculopathy	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Mental impairment	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Mononeuropathy multiplex	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Motor dysfunction	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Motor neurone disease	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Myasthenia gravis	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Nervous system disorder	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Optic neuritis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Paraesthesia	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Parkinson's disease	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Radiculitis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Radiculopathy	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Sciatica	0.27% 6/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.51% 12/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Seizure	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Senile dementia	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Sensory disturbance	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Spinal cord compression	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Subarachnoid haemorrhage	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Syncope	0.82% 18/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.85% 20/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Tarsal tunnel syndrome	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Thrombotic cerebral infarction	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Transient global amnesia	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Transient ischaemic attack	0.95% 21/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.81% 19/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Trigeminal neuralgia	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders VIIth nerve paralysis	0.14% 3/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Vascular dementia	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Vascular headache	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Vertebrobasilar insufficiency	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Aggression	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Anxiety	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Anxiety disorder	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Completed suicide	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Confusional state	0.27% 6/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Depression	0.50% 11/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.38% 9/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Emotional distress	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Hallucination	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Mental disorder	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Psychotic disorder	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Schizophrenia, paranoid type	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Suicide attempt	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Acute kidney injury	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.26% 6/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Bladder disorder	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Bladder irritation	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Bladder prolapse	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.26% 6/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Calculus bladder	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Calculus ureteric	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Calculus urethral	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Chronic kidney disease	0.14% 3/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Cystitis interstitial	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Diabetic nephropathy	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Haematuria	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Hydronephrosis	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Incontinence	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Mixed incontinence	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Nephrolithiasis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Nephropathy	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Renal colic	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Renal failure	0.14% 3/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.21% 5/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Stress urinary incontinence	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Tubulointerstitial nephritis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Ureteric stenosis	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Urethral disorder	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Urethral stenosis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Urge incontinence	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Urinary bladder polyp	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Urinary incontinence	0.18% 4/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.21% 5/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Urinary retention	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Renal and urinary disorders Urinary tract obstruction	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Breast mass	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Colpocele	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Cystocele	0.50% 11/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.21% 5/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Endometrial atrophy	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Endometrial metaplasia	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Female genital tract fistula	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Fibrocystic breast disease	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Genital prolapse	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Mammary duct ectasia	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Metrorrhagia	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Ovarian cyst	0.18% 4/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Rectocele	0.18% 4/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.21% 5/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Uterine cyst	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Uterine haemorrhage	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Uterine polyp	0.18% 4/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Uterine prolapse	0.41% 9/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.38% 9/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Vaginal cyst	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Vaginal prolapse	0.23% 5/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Reproductive system and breast disorders Vulval leukoplakia	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.18% 4/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Asthma	0.18% 4/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Bronchomalacia	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.63% 14/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.26% 6/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.27% 6/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.30% 7/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Emphysema	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Laryngeal cyst	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Mediastinal cyst	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Nasal ulcer	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Painful respiration	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.21% 5/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.86% 19/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.55% 13/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.27% 6/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.21% 5/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.14% 3/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.17% 4/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Tonsillar cyst	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Tracheomalacia	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Angioedema	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Diabetic foot	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Lichen sclerosus	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Lichenoid keratosis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Pemphigoid	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Pruritus	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Skin ulcer	0.14% 3/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.21% 5/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Skin and subcutaneous tissue disorders Urticaria	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Social circumstances Activities of daily living impaired	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Social circumstances Physical assault	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Surgical and medical procedures Anticoagulant therapy	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Surgical and medical procedures Arthrodesis	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Surgical and medical procedures Benign tumour excision	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Surgical and medical procedures Cardiac pacemaker replacement	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Surgical and medical procedures Chemotherapy	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Surgical and medical procedures Hip arthroplasty	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Surgical and medical procedures Hospitalisation	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Surgical and medical procedures Hysterectomy	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Surgical and medical procedures Joint arthroplasty	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Surgical and medical procedures Knee arthroplasty	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Surgical and medical procedures Rehabilitation therapy	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Surgical and medical procedures Spinal decompression	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Surgical and medical procedures Tooth extraction	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Surgical and medical procedures Urethral operation	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Accelerated hypertension	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Aortic aneurysm	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.21% 5/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Aortic dissection	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Aortic stenosis	0.23% 5/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.34% 8/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Arterial disorder	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Arterial haemorrhage	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Arterial occlusive disease	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Arteriosclerosis	0.23% 5/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.21% 5/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Circulatory collapse	0.14% 3/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Deep vein thrombosis	0.36% 8/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.34% 8/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Embolism venous	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Essential hypertension	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Femoral artery aneurysm	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Femoral artery occlusion	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Haematoma	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Haemorrhage	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Hypertension	0.82% 18/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.90% 21/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Hypertensive crisis	0.32% 7/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Hypotension	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Hypovolaemic shock	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Intermittent claudication	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Ischaemia	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Orthostatic hypotension	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Peripheral arterial occlusive disease	0.18% 4/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Peripheral artery stenosis	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Peripheral embolism	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Peripheral ischaemia	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Peripheral vascular disorder	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Peripheral venous disease	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Phlebolith	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Shock haemorrhagic	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Subclavian artery occlusion	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Temporal arteritis	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Thrombophlebitis	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.09% 2/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Thrombophlebitis superficial	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Thrombosis	0.18% 4/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Varicose vein	0.23% 5/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.13% 3/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Vasculitis	0.09% 2/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Vasculitis necrotising	0.00% 0/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.04% 1/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Venous thrombosis limb	0.05% 1/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Other adverse events

Measure	Placebo/ Denosumab 60 mg Q6M n=2206 participants at risk Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years.	Denosumab/ Denosumab 60 mg Q6M n=2343 participants at risk Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years (total of 10 years treatment).
Blood and lymphatic system disorders Anaemia	6.4% 141/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.2% 168/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Ear and labyrinth disorders Vertigo	6.3% 138/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.0% 140/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Eye disorders Cataract	14.5% 319/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	13.5% 317/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Constipation	6.4% 141/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.0% 118/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Gastrointestinal disorders Diarrhoea	6.3% 139/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.5% 152/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Bronchitis	9.3% 206/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	9.6% 226/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Cystitis	8.8% 194/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	9.0% 212/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Influenza	8.1% 179/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	8.2% 192/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Nasopharyngitis	16.9% 372/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	16.4% 385/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Pneumonia	6.2% 137/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.1% 167/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Upper respiratory tract infection	6.3% 139/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.5% 128/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Urinary tract infection	11.0% 242/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	10.7% 250/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Contusion	8.2% 181/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.5% 176/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Fall	10.9% 240/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	11.4% 268/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Metabolism and nutrition disorders Hypercholesterolaemia	9.7% 215/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	8.5% 200/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Arthralgia	23.9% 527/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	23.1% 541/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Back pain	22.7% 501/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	21.0% 493/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	8.9% 197/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	9.9% 231/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Osteoarthritis	15.0% 332/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	15.2% 355/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Pain in extremity	12.0% 264/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	12.5% 293/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Dizziness	7.8% 173/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.0% 163/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Headache	5.5% 121/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	4.4% 103/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Sciatica	6.8% 149/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.0% 165/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Psychiatric disorders Depression	6.1% 135/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	6.1% 143/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Respiratory, thoracic and mediastinal disorders Cough	7.8% 172/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.2% 168/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Vascular disorders Hypertension	20.9% 460/2206 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	21.3% 498/2343 • 84 months Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Results disclosure agreements

• Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
• Publication restrictions are in place

Restriction type: OTHER