Trial Outcomes & Findings for Determine the Efficacy, Safety and Tolerability of Denosumab (AMG 162) in the Treatment of Postmenopausal Women With Low Bone Mineral Density (NCT NCT00043186)

NCT ID: NCT00043186

Last Updated: 2013-09-18

Results Overview

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 412 participants
• Primary outcome timeframe: Baseline and Month 12
• Results posted on: 2013-09-18

Participant Flow

First Subject Enrolled: 11-May-2002 Last Subject Enrolled: 30-Apr-2003

Participant milestones

Measure	Placebo Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Overall Study STARTED	46	44	44	41	54	47	42	47	47
Overall Study COMPLETED	29	29	24	19	36	39	25	31	30
Overall Study NOT COMPLETED	17	15	20	22	18	8	17	16	17

Reasons for withdrawal

Measure	Placebo Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Overall Study Physician Decision	0	0	3	0	1	0	0	1	1
Overall Study Adverse Event	2	2	2	3	2	1	2	1	3
Overall Study Withdrawal by Subject	11	8	11	13	14	6	12	9	10
Overall Study Death	0	0	1	0	0	0	2	0	0
Overall Study Disease progression	1	0	0	3	0	0	0	4	0
Overall Study Ineligibility determined	0	0	0	0	0	0	0	0	1
Overall Study Lost to Follow-up	3	5	1	1	1	1	1	1	2
Overall Study Noncompliance	0	0	1	1	0	0	0	0	0
Overall Study Other	0	0	1	1	0	0	0	0	0

Baseline Characteristics

Determine the Efficacy, Safety and Tolerability of Denosumab (AMG 162) in the Treatment of Postmenopausal Women With Low Bone Mineral Density

Baseline characteristics by cohort

Measure	Placebo n=46 Participants Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M n=44 Participants Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M n=44 Participants Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M n=41 Participants Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M n=54 Participants Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M n=47 Participants Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M n=42 Participants Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M n=47 Participants Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg n=47 Participants Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.	Total n=412 Participants Total of all reporting groups
Age Continuous	63.7 Years STANDARD_DEVIATION 9.1 • n=5 Participants	62.8 Years STANDARD_DEVIATION 8.6 • n=7 Participants	62.3 Years STANDARD_DEVIATION 6 • n=5 Participants	61.2 Years STANDARD_DEVIATION 8.5 • n=4 Participants	61.4 Years STANDARD_DEVIATION 8.1 • n=21 Participants	63.1 Years STANDARD_DEVIATION 8.1 • n=8 Participants	64.9 Years STANDARD_DEVIATION 8.2 • n=8 Participants	60.5 Years STANDARD_DEVIATION 7.8 • n=24 Participants	62.8 Years STANDARD_DEVIATION 8.2 • n=42 Participants	62.5 Years STANDARD_DEVIATION 8.1 • n=42 Participants
Sex: Female, Male Female	46 Participants n=5 Participants	44 Participants n=7 Participants	44 Participants n=5 Participants	41 Participants n=4 Participants	54 Participants n=21 Participants	47 Participants n=8 Participants	42 Participants n=8 Participants	47 Participants n=24 Participants	47 Participants n=42 Participants	412 Participants n=42 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race/Ethnicity, Customized White or Caucasian	37 Participants n=5 Participants	33 Participants n=7 Participants	42 Participants n=5 Participants	36 Participants n=4 Participants	49 Participants n=21 Participants	39 Participants n=8 Participants	37 Participants n=8 Participants	42 Participants n=24 Participants	40 Participants n=42 Participants	355 Participants n=42 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	3 Participants n=8 Participants	0 Participants n=24 Participants	3 Participants n=42 Participants	12 Participants n=42 Participants
Race/Ethnicity, Customized Hispanic or Latino	8 Participants n=5 Participants	8 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	5 Participants n=8 Participants	2 Participants n=8 Participants	5 Participants n=24 Participants	4 Participants n=42 Participants	39 Participants n=42 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	4 Participants n=42 Participants
Race/Ethnicity, Customized Japanese	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants

PRIMARY outcome

Timeframe: Baseline and Month 12

Population: Randomized participants with non-missing Baseline and non-missing value at Month 12.

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Placebo n=40 Participants Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M n=36 Participants Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M n=36 Participants Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M n=32 Participants Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M n=48 Participants Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M n=41 Participants Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M n=37 Participants Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M n=41 Participants Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 for the Placebo and Denosumab Arms	-0.81 Percent change Standard Error 0.48	4.41 Percent change Standard Error 0.50	4.71 Percent change Standard Error 0.50	6.69 Percent change Standard Error 0.54	3.03 Percent change Standard Error 0.43	4.55 Percent change Standard Error 0.47	5.52 Percent change Standard Error 0.49	5.07 Percent change Standard Error 0.47	—

SECONDARY outcome

Timeframe: Baseline and Month 12

Population: Randomized participants with non-missing Baseline and non-missing value at Month 12

Serum C-Telopeptide (CTX). Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Placebo n=36 Participants Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M n=35 Participants Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M n=36 Participants Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M n=31 Participants Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M n=47 Participants Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M n=41 Participants Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M n=36 Participants Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M n=42 Participants Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg n=40 Participants Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Serum CTX Percent Change From Baseline at Month 12	-4.699 Percent change Interval -20.74 to 28.3	-61.366 Percent change Interval -74.42 to -41.92	-77.989 Percent change Interval -87.02 to -55.37	-87.238 Percent change Interval -90.53 to -71.25	-12.054 Percent change Interval -38.48 to 10.69	-70.757 Percent change Interval -81.47 to -55.78	-78.617 Percent change Interval -85.85 to -60.95	-84.107 Percent change Interval -90.7 to -77.85	-72.603 Percent change Interval -81.72 to -59.55

SECONDARY outcome

Timeframe: Baseline and Month 12

Population: Randomized participants with non-missing Baseline and non-missing value at Month 12.

Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Placebo n=36 Participants Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M n=35 Participants Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M n=36 Participants Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M n=31 Participants Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M n=47 Participants Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M n=40 Participants Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M n=36 Participants Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M n=42 Participants Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg n=40 Participants Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Urine NTX/Creatinine Percent Change From Baseline at Month 12	24.300 Percent change Interval -23.06 to 39.84	-40.018 Percent change Interval -49.76 to -6.38	-54.688 Percent change Interval -66.8 to -23.33	-60.652 Percent change Interval -73.16 to -46.4	-2.027 Percent change Interval -20.3 to 10.84	-36.523 Percent change Interval -54.67 to -16.06	-51.256 Percent change Interval -67.31 to -22.17	-58.502 Percent change Interval -70.55 to -29.84	-45.409 Percent change Interval -59.96 to -22.74

SECONDARY outcome

Timeframe: Baseline and Month 12

Population: Randomized participants with non-missing Baseline and non-missing value at Month 12.

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Placebo n=45 Participants Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 for the Alendronate Arm	4.59 Percent change Standard Error 0.45	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and 24 months

Population: Randomized participants with non-missing Baseline and non-missing value at Month 24.

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Placebo n=34 Participants Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M n=32 Participants Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M n=33 Participants Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M n=27 Participants Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M n=41 Participants Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M n=41 Participants Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M n=33 Participants Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M n=36 Participants Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg n=39 Participants Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24	-1.25 Percent change Standard Error 0.68	7.42 Percent change Standard Error 0.69	7.21 Percent change Standard Error 0.68	8.83 Percent change Standard Error 0.76	3.94 Percent change Standard Error 0.60	7.19 Percent change Standard Error 0.62	7.31 Percent change Standard Error 0.67	7.86 Percent change Standard Error 0.65	6.09 Percent change Standard Error 0.63

SECONDARY outcome

Timeframe: Baseline and 36 months

Population: Randomized participants with non-missing Baseline and non-missing value at Month 36.

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Placebo n=30 Participants Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M n=31 Participants Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M n=25 Participants Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M n=23 Participants Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M n=38 Participants Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M n=38 Participants Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M n=29 Participants Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M n=38 Participants Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg n=33 Participants Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36	-1.80 Percent change Standard Error 0.82	8.57 Percent change Standard Error 0.80	9.17 Percent change Standard Error 0.89	1.94 Percent change Standard Error 0.94	7.99 Percent change Standard Error 0.72	9.04 Percent change Standard Error 0.74	10.63 Percent change Standard Error 0.82	0.85 Percent change Standard Error 0.72	4.70 Percent change Standard Error 0.78

SECONDARY outcome

Timeframe: Baseline and 42 months

Population: Randomized participants with non-missing Baseline and non-missing value at Month 42.

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Placebo n=8 Participants Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M n=5 Participants Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M n=7 Participants Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M n=5 Participants Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M n=15 Participants Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M n=12 Participants Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M n=6 Participants Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M n=7 Participants Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg n=10 Participants Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 42	1.09 Percent change Standard Error 1.70	7.21 Percent change Standard Error 2.13	10.04 Percent change Standard Error 1.86	5.06 Percent change Standard Error 2.13	9.46 Percent change Standard Error 1.24	9.59 Percent change Standard Error 1.40	9.99 Percent change Standard Error 1.93	1.06 Percent change Standard Error 1.80	6.51 Percent change Standard Error 1.51

SECONDARY outcome

Timeframe: Baseline and 48 months

Population: Randomized participants with non-missing Baseline and non-missing value at Month 48.

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Placebo n=29 Participants Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M n=29 Participants Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M n=24 Participants Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M n=20 Participants Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M n=37 Participants Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M n=39 Participants Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M n=27 Participants Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M n=30 Participants Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg n=31 Participants Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 48	-2.39 Percent change Standard Error 1.11	9.35 Percent change Standard Error 1.09	9.93 Percent change Standard Error 1.20	9.03 Percent change Standard Error 1.33	10.10 Percent change Standard Error 0.96	10.34 Percent change Standard Error 0.96	11.76 Percent change Standard Error 1.13	2.50 Percent change Standard Error 1.07	4.54 Percent change Standard Error 1.06

SECONDARY outcome

Timeframe: Baseline and 24 months

Population: Randomized participants with non-missing Baseline and non-missing value at Month 24.

Serum C-Telopeptide (CTX). Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Placebo n=32 Participants Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M n=30 Participants Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M n=32 Participants Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M n=25 Participants Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M n=38 Participants Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M n=39 Participants Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M n=31 Participants Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M n=33 Participants Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg n=38 Participants Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Serum CTX Percent Change From Baseline at Month 24	-5.940 Percent change Interval -23.22 to 20.61	-50.687 Percent change Interval -73.73 to -27.21	-74.078 Percent change Interval -84.96 to -52.32	-83.985 Percent change Interval -89.66 to -74.02	-8.467 Percent change Interval -24.02 to 25.84	-68.437 Percent change Interval -81.8 to -44.39	-80.460 Percent change Interval -89.31 to -43.68	-85.680 Percent change Interval -90.94 to -78.32	-69.386 Percent change Interval -79.82 to -52.04

SECONDARY outcome

Timeframe: Baseline and 36 months

Population: Randomized participants with non-missing Baseline and non-missing value at Month 36.

Serum C-Telopeptide (CTX). Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Placebo n=29 Participants Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M n=30 Participants Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M n=24 Participants Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M n=22 Participants Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M n=31 Participants Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M n=36 Participants Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M n=27 Participants Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M n=36 Participants Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg n=32 Participants Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Serum CTX Percent Change From Baseline at Month 36	-16.577 Percent change Interval -28.96 to -0.29	-62.298 Percent change Interval -81.94 to -42.09	-53.643 Percent change Interval -82.23 to -34.04	56.286 Percent change Interval 21.35 to 73.85	-57.500 Percent change Interval -75.77 to -23.56	-54.418 Percent change Interval -72.02 to -12.53	-45.057 Percent change Interval -81.69 to -11.29	72.135 Percent change Interval 34.18 to 136.0	-33.982 Percent change Interval -56.86 to -21.93

SECONDARY outcome

Timeframe: Baseline and 42 months

Population: Randomized participantswith non-missing Baseline and non-missing value at Month 42.

Serum C-Telopeptide (CTX). Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Placebo n=23 Participants Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M n=27 Participants Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M n=21 Participants Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M n=16 Participants Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M n=30 Participants Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M n=35 Participants Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M n=24 Participants Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M n=31 Participants Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg n=27 Participants Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Serum CTX Percent Change From Baseline at Month 42	-16.279 Percent change Interval -31.66 to 18.31	-63.543 Percent change Interval -83.99 to -38.15	-40.827 Percent change Interval -85.17 to -13.72	-62.334 Percent change Interval -88.37 to -27.85	-46.408 Percent change Interval -80.65 to -32.46	-57.255 Percent change Interval -74.6 to -23.04	-56.377 Percent change Interval -77.35 to -20.98	33.999 Percent change Interval 0.15 to 49.68	-46.743 Percent change Interval -58.94 to -26.14

SECONDARY outcome

Timeframe: Baseline and 48 months

Population: Randomized participants with non-missing Baseline and non-missing value at Month 48.

Serum C-Telopeptide (CTX). Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Placebo n=27 Participants Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M n=29 Participants Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M n=24 Participants Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M n=16 Participants Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M n=34 Participants Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M n=37 Participants Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M n=24 Participants Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M n=30 Participants Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg n=29 Participants Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Serum CTX Percent Change From Baseline at Month 48	-14.561 Percent change Interval -33.09 to 6.61	-40.016 Percent change Interval -80.76 to 0.11	-34.999 Percent change Interval -78.25 to -7.84	-52.656 Percent change Interval -78.86 to -5.25	-39.899 Percent change Interval -73.8 to -9.78	-51.494 Percent change Interval -78.57 to -14.62	-36.480 Percent change Interval -70.12 to -18.54	7.067 Percent change Interval -17.06 to 31.25	-43.724 Percent change Interval -56.28 to -14.07

SECONDARY outcome

Timeframe: Baseline and 24 months

Population: Randomized participants with non-missing Baseline and non-missing value at Month 24.

Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Placebo n=32 Participants Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M n=30 Participants Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M n=32 Participants Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M n=25 Participants Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M n=38 Participants Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M n=39 Participants Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M n=31 Participants Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M n=33 Participants Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg n=39 Participants Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Urine NTX/Creatinine Percent Change From Baseline at Month 24	14.422 Percent change Interval -5.3 to 56.37	-19.699 Percent change Interval -51.71 to 1.61	-37.691 Percent change Interval -60.65 to -4.19	-49.907 Percent change Interval -68.26 to -20.43	2.134 Percent change Interval -15.6 to 45.1	-32.303 Percent change Interval -54.06 to 15.35	-37.001 Percent change Interval -72.15 to 11.74	-47.105 Percent change Interval -76.14 to -24.75	-44.482 Percent change Interval -59.46 to -8.98

SECONDARY outcome

Timeframe: Baseline and 36 months

Population: Randomized participants with non-missing Baseline and non-missing value at Month 36.

Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Placebo n=29 Participants Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M n=30 Participants Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M n=24 Participants Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M n=22 Participants Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M n=31 Participants Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M n=36 Participants Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M n=26 Participants Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M n=36 Participants Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg n=31 Participants Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Urine NTX/Creatinine Percent Change From Baseline at Month 36	0.508 Percent change Interval -21.6 to 11.89	-33.294 Percent change Interval -56.03 to -3.63	-47.752 Percent change Interval -58.74 to -16.01	82.910 Percent change Interval 32.79 to 108.7	-44.301 Percent change Interval -58.12 to -15.68	-36.874 Percent change Interval -57.37 to -5.32	-27.174 Percent change Interval -56.3 to 25.52	70.997 Percent change Interval 24.8 to 125.9	-15.627 Percent change Interval -40.75 to 15.42

SECONDARY outcome

Timeframe: Baseline and 42 months

Population: Randomized participants with non-missing Baseline and non-missing value at Month 42.

Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Placebo n=24 Participants Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M n=27 Participants Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M n=21 Participants Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M n=16 Participants Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M n=30 Participants Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M n=35 Participants Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M n=24 Participants Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M n=31 Participants Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg n=27 Participants Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Urine NTX/Creatinine Percent Change From Baseline at Month 42	-18.102 Percent change Interval -31.05 to 30.83	-40.741 Percent change Interval -60.82 to -12.95	-40.043 Percent change Interval -65.63 to -9.12	-58.893 Percent change Interval -67.49 to -14.26	-47.188 Percent change Interval -69.64 to -25.46	-39.269 Percent change Interval -64.25 to -4.97	-46.674 Percent change Interval -63.98 to -9.33	26.277 Percent change Interval -16.99 to 88.12	-33.102 Percent change Interval -53.1 to -19.07

SECONDARY outcome

Timeframe: Baseline and 48 months

Population: Randomized participants with non-missing Baseline and non-missing value at Month 48.

Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Placebo n=27 Participants Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M n=28 Participants Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M n=24 Participants Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M n=16 Participants Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M n=32 Participants Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M n=35 Participants Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M n=24 Participants Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M n=30 Participants Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg n=28 Participants Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Urine NTX/Creatinine Percent Change From Baseline at Month 48	-21.064 Percent change Interval -36.94 to 32.77	-23.311 Percent change Interval -62.33 to 11.43	-38.002 Percent change Interval -67.11 to -15.91	-50.864 Percent change Interval -80.48 to -9.49	-46.128 Percent change Interval -64.44 to -14.07	-40.375 Percent change Interval -70.06 to -0.46	-41.998 Percent change Interval -70.45 to -6.62	7.884 Percent change Interval -35.02 to 72.97	-32.198 Percent change Interval -59.36 to 6.68

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: Randomized participants with non-missing Baseline and non-missing value at Month 12.

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Placebo n=40 Participants Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M n=36 Participants Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M n=36 Participants Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M n=32 Participants Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M n=48 Participants Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M n=42 Participants Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M n=37 Participants Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M n=41 Participants Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg n=45 Participants Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Total Hip Bone Mineral Density Percent Change From Baseline at Month 12	-0.56 Percent change Standard Error 0.37	2.89 Percent change Standard Error 0.38	2.45 Percent change Standard Error 0.39	3.32 Percent change Standard Error 0.42	1.94 Percent change Standard Error 0.33	3.56 Percent change Standard Error 0.36	2.53 Percent change Standard Error 0.38	2.33 Percent change Standard Error 0.36	2.11 Percent change Standard Error 0.35

SECONDARY outcome

Timeframe: Baseline and 24 months

Population: Randomized participants with non-missing Baseline and non-missing value at Month 24.

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Placebo n=35 Participants Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M n=32 Participants Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M n=33 Participants Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M n=27 Participants Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M n=41 Participants Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M n=41 Participants Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M n=33 Participants Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M n=35 Participants Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg n=39 Participants Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Total Hip Bone Mineral Density Percent Change From Baseline at Month 24	-1.92 Percent change Standard Error 0.44	4.04 Percent change Standard Error 0.45	3.55 Percent change Standard Error 0.44	5.03 Percent change Standard Error 0.50	2.62 Percent change Standard Error 0.39	4.96 Percent change Standard Error 0.40	3.67 Percent change Standard Error 0.44	4.18 Percent change Standard Error 0.43	3.27 Percent change Standard Error 0.41

SECONDARY outcome

Timeframe: Baseline and 36 months

Population: Randomized participants with non-missing Baseline and non-missing value at Month 36.

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Placebo n=30 Participants Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M n=31 Participants Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M n=25 Participants Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M n=23 Participants Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M n=38 Participants Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M n=37 Participants Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M n=29 Participants Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M n=38 Participants Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg n=33 Participants Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Total Hip Bone Mineral Density Percent Change From Baseline at Month 36	-2.84 Percent change Standard Error 0.60	4.79 Percent change Standard Error 0.58	4.41 Percent change Standard Error 0.65	-1.23 Percent change Standard Error 0.68	4.31 Percent change Standard Error 0.52	5.83 Percent change Standard Error 0.54	4.33 Percent change Standard Error 0.60	-1.43 Percent change Standard Error 0.53	0.93 Percent change Standard Error 0.57

SECONDARY outcome

Timeframe: Baseline and 42 months

Population: Randomized participants with non-missing Baseline and non-missing value at Month 42.

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Placebo n=8 Participants Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M n=5 Participants Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M n=7 Participants Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M n=5 Participants Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M n=15 Participants Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M n=12 Participants Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M n=6 Participants Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M n=7 Participants Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg n=10 Participants Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Total Hip Bone Mineral Density Percent Change From Baseline at Month 42	-1.96 Percent change Standard Error 1.16	5.01 Percent change Standard Error 1.43	3.98 Percent change Standard Error 1.28	2.37 Percent change Standard Error 1.46	4.54 Percent change Standard Error 0.85	6.34 Percent change Standard Error 0.98	4.70 Percent change Standard Error 1.32	-2.67 Percent change Standard Error 1.23	2.98 Percent change Standard Error 1.03

SECONDARY outcome

Timeframe: Baseline and 48 months

Population: Randomized participants with non-missing Baseline and non-missing value at Month 48.

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Placebo n=29 Participants Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M n=29 Participants Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M n=24 Participants Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M n=20 Participants Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M n=37 Participants Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M n=39 Participants Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M n=27 Participants Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M n=30 Participants Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg n=31 Participants Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Total Hip Bone Mineral Density Percent Change From Baseline at Month 48	-3.52 Percent change Standard Error 0.65	5.45 Percent change Standard Error 0.63	4.03 Percent change Standard Error 0.70	3.86 Percent change Standard Error 0.77	4.82 Percent change Standard Error 0.56	6.06 Percent change Standard Error 0.56	4.99 Percent change Standard Error 0.66	-1.37 Percent change Standard Error 0.62	1.17 Percent change Standard Error 0.62

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: Randomized participants with non-missing Baseline and non-missing value at Month 12.

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Placebo n=39 Participants Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M n=35 Participants Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M n=35 Participants Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M n=32 Participants Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M n=44 Participants Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M n=43 Participants Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M n=37 Participants Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M n=37 Participants Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg n=42 Participants Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 12	-1.97 Percent change Standard Error 0.50	0.89 Percent change Standard Error 0.52	0.40 Percent change Standard Error 0.53	1.10 Percent change Standard Error 0.55	0.94 Percent change Standard Error 0.46	1.29 Percent change Standard Error 0.48	1.07 Percent change Standard Error 0.50	1.09 Percent change Standard Error 0.51	-0.53 Percent change Standard Error 0.47

SECONDARY outcome

Timeframe: Baseline and 24 months

Population: Randomized participants with non-missing Baseline and non-missing value at Month 24.

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Placebo n=34 Participants Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M n=32 Participants Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M n=32 Participants Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M n=27 Participants Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M n=38 Participants Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M n=41 Participants Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M n=33 Participants Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M n=33 Participants Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg n=35 Participants Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24	-2.78 Percent change Standard Error 0.56	1.31 Percent change Standard Error 0.57	0.62 Percent change Standard Error 0.58	1.30 Percent change Standard Error 0.63	2.48 Percent change Standard Error 0.52	1.89 Percent change Standard Error 0.51	1.48 Percent change Standard Error 0.56	0.81 Percent change Standard Error 0.56	-0.78 Percent change Standard Error 0.55

SECONDARY outcome

Timeframe: Baseline and 36 months

Population: Randomized participants with non-missing Baseline and non-missing value at Month 36.

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Placebo n=29 Participants Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M n=31 Participants Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M n=24 Participants Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M n=23 Participants Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M n=37 Participants Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M n=39 Participants Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M n=29 Participants Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M n=35 Participants Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg n=30 Participants Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 36	-3.64 Percent change Standard Error 0.63	1.99 Percent change Standard Error 0.60	1.06 Percent change Standard Error 0.69	1.05 Percent change Standard Error 0.71	2.08 Percent change Standard Error 0.55	2.69 Percent change Standard Error 0.55	1.92 Percent change Standard Error 0.62	0.12 Percent change Standard Error 0.57	-0.95 Percent change Standard Error 0.61

SECONDARY outcome

Timeframe: Baseline and 42 months

Population: Randomized participants with non-missing Baseline and non-missing value at Month 42.

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Placebo n=2 Participants Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M n=2 Participants Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M n=2 Participants Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M n=2 Participants Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M n=7 Participants Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M n=3 Participants Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M n=1 Participants Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M n=3 Participants Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg n=1 Participants Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 42	-6.59 Percent change Standard Error 3.00	1.00 Percent change Standard Error 3.26	0.82 Percent change Standard Error 2.92	-3.91 Percent change Standard Error 3.39	1.29 Percent change Standard Error 2.14	-0.87 Percent change Standard Error 2.93	0.02 Percent change Standard Error 5.00	0.59 Percent change Standard Error 2.52	-3.32 Percent change Standard Error 3.95

SECONDARY outcome

Timeframe: Baseline and 48 months

Population: Randomized participants with non-missing baseline and non-missing value at Month 48.

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Placebo n=28 Participants Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M n=29 Participants Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M n=22 Participants Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M n=19 Participants Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M n=35 Participants Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M n=38 Participants Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M n=27 Participants Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M n=28 Participants Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg n=28 Participants Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 48	-4.67 Percent change Standard Error 0.75	1.04 Percent change Standard Error 0.73	1.42 Percent change Standard Error 0.84	1.77 Percent change Standard Error 0.91	1.74 Percent change Standard Error 0.66	1.71 Percent change Standard Error 0.65	1.37 Percent change Standard Error 0.75	-0.94 Percent change Standard Error 0.74	-2.67 Percent change Standard Error 0.75

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: Randomized participants with non-missing Baseline and non-missing value at Month 12.

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Placebo n=36 Participants Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M n=36 Participants Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M n=35 Participants Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M n=29 Participants Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M n=43 Participants Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M n=42 Participants Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M n=34 Participants Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M n=38 Participants Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg n=39 Participants Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Total Body Bone Mineral Density Percent Change From Baseline at Month 12	-0.21 Percent change Standard Error 0.46	1.82 Percent change Standard Error 0.45	1.80 Percent change Standard Error 0.46	2.74 Percent change Standard Error 0.51	0.55 Percent change Standard Error 0.41	2.51 Percent change Standard Error 0.43	1.78 Percent change Standard Error 0.46	2.08 Percent change Standard Error 0.44	1.51 Percent change Standard Error 0.44

SECONDARY outcome

Timeframe: Baseline and 24 months

Population: Randomized participants with non-missing Baseline and non-missing value at Month 24.

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Placebo n=33 Participants Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M n=31 Participants Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M n=33 Participants Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M n=24 Participants Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M n=37 Participants Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M n=40 Participants Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M n=32 Participants Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M n=32 Participants Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg n=34 Participants Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Total Body Bone Mineral Density Percent Change From Baseline at Month 24	-1.64 Percent change Standard Error 0.53	2.59 Percent change Standard Error 0.54	2.91 Percent change Standard Error 0.53	4.44 Percent change Standard Error 0.62	0.89 Percent change Standard Error 0.49	2.57 Percent change Standard Error 0.49	3.00 Percent change Standard Error 0.53	2.75 Percent change Standard Error 0.53	1.50 Percent change Standard Error 0.52

SECONDARY outcome

Timeframe: Baseline and 36 months

Population: Randomized participants with non-missing Baseline and non-missing value at Month 36.

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Placebo n=28 Participants Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M n=31 Participants Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M n=25 Participants Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M n=21 Participants Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M n=35 Participants Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M n=39 Participants Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M n=27 Participants Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M n=36 Participants Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg n=28 Participants Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Total Body Bone Mineral Density Percent Change From Baseline at Month 36	-1.61 Percent change Standard Error 0.94	3.14 Percent change Standard Error 0.88	3.04 Percent change Standard Error 0.98	2.34 Percent change Standard Error 1.09	2.04 Percent change Standard Error 0.83	2.80 Percent change Standard Error 0.80	2.59 Percent change Standard Error 0.94	-0.29 Percent change Standard Error 0.83	4.55 Percent change Standard Error 0.94

SECONDARY outcome

Timeframe: Baseline and 42 months

Population: Randomized participants with non-missing Baseline and non-missing value at Month 42.

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Placebo n=2 Participants Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M n=1 Participants Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M n=2 Participants Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M n=1 Participants Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M n=6 Participants Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M n=2 Participants Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M n=1 Participants Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M n=3 Participants Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg n=1 Participants Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Total Body Bone Mineral Density Percent Change From Baseline at Month 42	1.61 Percent change Standard Error 1.76	1.90 Percent change Standard Error 3.71	4.05 Percent change Standard Error 1.70	8.85 Percent change Standard Error 3.07	3.72 Percent change Standard Error 1.97	4.92 Percent change Standard Error 1.83	3.79 Percent change Standard Error 3.63	-0.75 Percent change Standard Error 1.50	2.85 Percent change Standard Error 2.67

SECONDARY outcome

Timeframe: Baseline and 48 months

Population: Randomized participants with non-missing Baseline and non-missing value at Month 48.

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Placebo n=28 Participants Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M n=28 Participants Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M n=23 Participants Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M n=17 Participants Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M n=35 Participants Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M n=38 Participants Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M n=25 Participants Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M n=29 Participants Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg n=27 Participants Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Total Body Bone Mineral Density Percent Change From Baseline at Month 48	-2.54 Percent change Standard Error 0.99	3.68 Percent change Standard Error 0.98	3.38 Percent change Standard Error 1.07	3.76 Percent change Standard Error 1.27	3.42 Percent change Standard Error 0.86	3.43 Percent change Standard Error 0.87	3.68 Percent change Standard Error 1.03	-0.29 Percent change Standard Error 0.96	4.49 Percent change Standard Error 1.00

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: Randomized participants with non-missing Baseline and non-missing value at Month 12.

Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Placebo n=36 Participants Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M n=35 Participants Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M n=36 Participants Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M n=31 Participants Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M n=47 Participants Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M n=40 Participants Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M n=36 Participants Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M n=42 Participants Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg n=39 Participants Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 12	-4.609 Percent change Interval -26.46 to 30.31	-62.716 Percent change Interval -77.57 to -47.64	-60.098 Percent change Interval -76.61 to -41.34	-70.256 Percent change Interval -80.58 to -55.16	-39.474 Percent change Interval -64.97 to -13.73	-65.215 Percent change Interval -77.11 to -51.79	-61.979 Percent change Interval -74.25 to -50.61	-67.634 Percent change Interval -75.9 to -50.19	-61.059 Percent change Interval -69.89 to -46.08

SECONDARY outcome

Timeframe: Baseline and 24 months

Population: Randomized participants with non-missing Baseline and non-missing value at Month 24.

Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Placebo n=32 Participants Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M n=30 Participants Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M n=32 Participants Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M n=25 Participants Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M n=38 Participants Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M n=37 Participants Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M n=31 Participants Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M n=33 Participants Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg n=39 Participants Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 24	16.464 Percent change Interval -20.18 to 52.94	-41.225 Percent change Interval -65.61 to -22.04	-47.597 Percent change Interval -69.11 to -16.28	-57.905 Percent change Interval -66.41 to -22.36	-22.350 Percent change Interval -44.05 to 0.5	-43.448 Percent change Interval -62.7 to -18.28	-50.176 Percent change Interval -64.82 to -23.14	-48.833 Percent change Interval -71.34 to -27.38	-48.778 Percent change Interval -58.87 to -25.77

SECONDARY outcome

Timeframe: Baseline and 36 months

Population: Randomized participants with non-missing Baseline and non-missing value at Month 36.

Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Placebo n=29 Participants Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M n=29 Participants Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M n=24 Participants Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M n=22 Participants Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M n=31 Participants Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M n=36 Participants Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M n=26 Participants Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M n=34 Participants Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg n=31 Participants Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 36	1.955 Percent change Interval -28.21 to 45.67	-39.012 Percent change Interval -66.11 to -12.1	-56.021 Percent change Interval -69.45 to -21.31	22.343 Percent change Interval -0.27 to 49.28	-47.500 Percent change Interval -63.87 to -32.19	-42.541 Percent change Interval -64.46 to -24.35	-47.418 Percent change Interval -57.7 to -22.78	61.747 Percent change Interval 14.65 to 101.28	-8.209 Percent change Interval -40.84 to 7.8

SECONDARY outcome

Timeframe: Baseline and 42 months

Population: Randomized participants with non-missing Baseline and non-missing value at Month 42.

Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Placebo n=24 Participants Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M n=27 Participants Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M n=21 Participants Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M n=16 Participants Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M n=31 Participants Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M n=35 Participants Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M n=23 Participants Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M n=31 Participants Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg n=27 Participants Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 42	1.288 Percent change Interval -25.01 to 51.68	-40.182 Percent change Interval -65.62 to -11.21	-40.819 Percent change Interval -64.78 to -6.13	-52.684 Percent change Interval -67.62 to -34.69	-53.763 Percent change Interval -62.49 to -28.55	-44.892 Percent change Interval -62.36 to -25.45	-48.303 Percent change Interval -59.51 to -18.6	17.841 Percent change Interval 4.18 to 82.99	-22.069 Percent change Interval -41.0 to 8.92

SECONDARY outcome

Timeframe: Baseline and 48 months

Population: Randomized participants with non-missing Baseline and non-missing value at Month 48.

Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Placebo n=27 Participants Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M n=29 Participants Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M n=24 Participants Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M n=16 Participants Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M n=34 Participants Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M n=37 Participants Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M n=24 Participants Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M n=30 Participants Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg n=29 Participants Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 48	18.122 Percent change Interval -28.72 to 59.58	-34.727 Percent change Interval -56.34 to 3.83	-45.779 Percent change Interval -60.49 to 9.42	-47.770 Percent change Interval -60.61 to -30.76	-46.286 Percent change Interval -57.67 to -24.26	-34.361 Percent change Interval -59.73 to -9.38	-42.653 Percent change Interval -61.39 to -17.29	21.053 Percent change Interval 8.0 to 54.55	-17.891 Percent change Interval -27.39 to 12.52

Adverse Events

Placebo

Serious events: 5 serious events

Other events: 43 other events

Deaths: 0 deaths

Denosumab 6 mg Q3M

Serious events: 7 serious events

Other events: 38 other events

Deaths: 0 deaths

Denosumab 14 mg Q3M

Serious events: 13 serious events

Other events: 39 other events

Deaths: 0 deaths

Denosumab 30 mg Q3M

Serious events: 9 serious events

Other events: 35 other events

Deaths: 0 deaths

Denosumab 14 mg Q6M

Serious events: 7 serious events

Other events: 44 other events

Deaths: 0 deaths

Denosumab 60 mg Q6M

Serious events: 5 serious events

Other events: 42 other events

Deaths: 0 deaths

Denosumab 100 mg Q6M

Serious events: 9 serious events

Other events: 38 other events

Deaths: 0 deaths

Denosumab 210 mg Q6M

Serious events: 6 serious events

Other events: 41 other events

Deaths: 0 deaths

Alendronate 70 mg

Serious events: 8 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=46 participants at risk Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M n=43 participants at risk Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M n=44 participants at risk Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M n=40 participants at risk Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M n=53 participants at risk Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M n=47 participants at risk Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M n=41 participants at risk Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M n=46 participants at risk Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg n=46 participants at risk Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
Cardiac disorders Atrial flutter	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Bradycardia	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Coronary artery disease	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.1% 1/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Coronary artery stenosis	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Myocardial infarction	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Pericardial effusion	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Sick sinus syndrome	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Ear and labyrinth disorders Vertigo	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.9% 1/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal pain	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.1% 1/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Arrhythmia	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Atrial fibrillation	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal strangulated hernia	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.1% 1/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Pancreatitis	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Non-cardiac chest pain	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.9% 1/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Pyrexia	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Soft tissue inflammation	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Cholecystitis	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Gallbladder disorder	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.1% 1/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Appendicitis	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.1% 1/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Bacteraemia	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Bronchopneumonia	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Catheter site cellulitis	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Diverticulitis	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.9% 1/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Labyrinthitis	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pneumonia	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pneumonia primary atypical	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Urinary tract infection	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Carbon monoxide poisoning	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Lung injury	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Sternal fracture	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Dehydration	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Diabetes mellitus non-insulin-dependent	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	3.8% 2/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Pain in jaw	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer in situ	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.5% 2/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Angina pectoris	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.7% 2/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Aortic valve stenosis	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.9% 1/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Anaemia	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Acute coronary syndrome	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Follicle centre lymphoma, follicular grade I, II, III stage II	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hypergammaglobulinaemia benign monoclonal	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.1% 1/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian epithelial cancer	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Carotid artery stenosis	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Cerebral haemorrhage	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.1% 1/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Cerebrovascular accident	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Convulsion	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.9% 1/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Lacunar infarction	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Neurological symptom	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.9% 1/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Syncope	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Alcoholism	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Bladder prolapse	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Reproductive system and breast disorders Adenomyosis	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.9% 1/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Reproductive system and breast disorders Endometrial hyperplasia	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.9% 1/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Bronchial hyperactivity	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Surgical and medical procedures Colostomy closure	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Hypotension	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Thrombosis	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Other adverse events

Measure	Placebo n=46 participants at risk Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.	Denosumab 6 mg Q3M n=43 participants at risk Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 14 mg Q3M n=44 participants at risk Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 30 mg Q3M n=40 participants at risk Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.	Denosumab 14 mg Q6M n=53 participants at risk Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 60 mg Q6M n=47 participants at risk Participants received denosumab 60 mg SC every 6 months until Month 42.	Denosumab 100 mg Q6M n=41 participants at risk Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.	Denosumab 210 mg Q6M n=46 participants at risk Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.	Alendronate 70 mg n=46 participants at risk Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
General disorders Injection site erythema	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.1% 1/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Oedema peripheral	10.9% 5/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	10.0% 4/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	3.8% 2/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.5% 4/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Pain	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.0% 3/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 4/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	3.8% 2/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.1% 1/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Immune system disorders Hypersensitivity	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.7% 2/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.9% 1/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.4% 3/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Immune system disorders Seasonal allergy	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.0% 3/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.5% 2/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	10.0% 4/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.7% 3/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.4% 3/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Stomach discomfort	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.1% 1/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Toothache	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.0% 3/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.9% 1/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Vomiting	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.7% 2/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.5% 2/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.5% 3/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.9% 1/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.1% 1/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Chills	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.8% 3/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Fatigue	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.0% 3/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.5% 2/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.5% 4/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.7% 4/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Influenza like illness	10.9% 5/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.3% 4/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 4/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.5% 3/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	18.9% 10/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	23.4% 11/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	14.6% 6/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	15.2% 7/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Injection site bruising	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Bronchitis	10.9% 5/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.7% 2/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	25.0% 10/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.5% 4/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.4% 3/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	10.9% 5/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.7% 4/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Cataract	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.0% 3/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.8% 3/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.5% 3/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.7% 3/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.8% 4/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal distension	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	10.0% 4/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.7% 3/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal pain	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.3% 4/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.0% 2/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.9% 1/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.4% 3/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.3% 3/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal pain lower	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.9% 1/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.3% 3/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.8% 3/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.7% 3/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.9% 2/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Constipation	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.0% 3/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.0% 2/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.4% 5/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	10.6% 5/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.3% 3/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	13.0% 6/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Diarrhoea	13.0% 6/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.6% 5/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.4% 5/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.5% 3/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.7% 3/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.1% 1/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	14.6% 6/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	10.9% 5/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.7% 4/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Diverticulum	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.9% 1/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Dyspepsia	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.6% 5/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.4% 5/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	22.6% 12/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.8% 6/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	14.6% 6/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.7% 4/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	26.1% 12/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Flatulence	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.8% 3/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	3.8% 2/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.4% 3/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gastritis	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.5% 2/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	3.8% 2/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.9% 2/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gastrooesophageal reflux disease	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	18.6% 8/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.5% 2/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 5/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	15.1% 8/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	17.0% 8/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.8% 4/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	10.9% 5/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	15.2% 7/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Haemorrhoids	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.7% 2/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.4% 3/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Hiatus hernia	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.8% 3/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.9% 1/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Nausea	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.0% 3/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	13.6% 6/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	15.0% 6/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.3% 6/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	10.6% 5/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.3% 3/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	19.6% 9/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	21.7% 10/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Anaemia	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.9% 1/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	10.9% 5/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Palpitations	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.5% 2/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.7% 3/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.1% 1/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Blepharitis	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Dental caries	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.5% 3/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.9% 1/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.1% 1/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Diverticulitis	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.5% 3/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.9% 1/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.9% 2/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Ear infection	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.0% 2/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.7% 3/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Gastroenteritis	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.4% 3/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Gastroenteritis viral	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.9% 1/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.1% 1/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.8% 4/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Herpes zoster	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.5% 2/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	3.8% 2/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Nasopharyngitis	15.2% 7/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	25.6% 11/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	20.5% 9/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	10.0% 4/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.5% 4/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	23.4% 11/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	26.8% 11/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	21.7% 10/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	13.0% 6/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pneumonia	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.4% 3/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.9% 2/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Sinusitis	19.6% 9/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.3% 4/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.5% 2/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	15.0% 6/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	18.9% 10/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.8% 6/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	17.1% 7/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	13.0% 6/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Tooth infection	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.0% 3/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.7% 3/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Upper respiratory tract infection	23.9% 11/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	34.9% 15/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	22.7% 10/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	20.0% 8/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	24.5% 13/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	34.0% 16/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	19.5% 8/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	39.1% 18/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	30.4% 14/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Urinary tract infection	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.0% 3/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 4/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	20.0% 8/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.4% 5/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.8% 6/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.2% 5/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	17.4% 8/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	13.0% 6/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Viral infection	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.0% 3/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.5% 4/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.4% 3/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.3% 4/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.4% 3/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Contusion	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.7% 2/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	15.0% 6/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.4% 5/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.5% 4/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	14.6% 6/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	13.0% 6/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Excoriation	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.1% 1/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.3% 3/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Fall	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.7% 2/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 5/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.9% 1/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	10.6% 5/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.8% 4/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Foot fracture	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.5% 2/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.0% 2/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	3.8% 2/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.5% 4/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.7% 4/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Joint sprain	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.5% 3/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.7% 3/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.5% 4/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.9% 2/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Muscle strain	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.7% 2/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.4% 3/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Procedural pain	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.5% 2/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.0% 2/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.5% 4/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.4% 3/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.8% 3/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.1% 1/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.5% 3/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.1% 1/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Dehydration	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.1% 1/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.0% 3/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.4% 5/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.0% 2/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	3.8% 2/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	14.9% 7/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.9% 2/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Arthralgia	30.4% 14/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.3% 7/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	29.5% 13/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	22.5% 9/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	22.6% 12/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	23.4% 11/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	24.4% 10/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	26.1% 12/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	17.4% 8/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Arthritis	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.8% 3/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.0% 2/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	3.8% 2/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.1% 1/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.3% 3/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Back pain	13.0% 6/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	18.6% 8/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	29.5% 13/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 5/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	18.9% 10/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	17.0% 8/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	24.4% 10/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	19.6% 9/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	15.2% 7/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Bursitis	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.5% 3/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.9% 2/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Joint stiffness	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.0% 3/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.0% 2/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.9% 1/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.9% 2/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Joint swelling	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.4% 5/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.5% 4/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.1% 1/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.9% 2/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Muscle spasms	15.2% 7/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.3% 4/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 4/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.5% 3/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.3% 6/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	10.6% 5/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.2% 5/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	10.9% 5/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	10.9% 5/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.5% 3/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	3.8% 2/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.1% 1/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.5% 3/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.9% 1/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.1% 1/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.3% 3/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.7% 4/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Myalgia	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.7% 2/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.8% 3/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.4% 5/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	10.6% 5/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.9% 2/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	10.9% 5/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.7% 4/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.0% 3/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.8% 3/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.7% 3/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.3% 3/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Osteoarthritis	8.7% 4/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.7% 2/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.0% 2/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	10.9% 5/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Pain in extremity	17.4% 8/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	14.0% 6/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	13.6% 6/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	17.5% 7/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	20.8% 11/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	14.9% 7/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.2% 5/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	28.3% 13/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	15.2% 7/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Shoulder pain	15.2% 7/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	14.0% 6/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.4% 5/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.0% 2/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.7% 3/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.8% 6/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	14.6% 6/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.7% 4/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Tendonitis	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.8% 3/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.0% 2/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.8% 4/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Dizziness	8.7% 4/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.4% 5/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.5% 3/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.3% 6/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.5% 4/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.9% 2/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.7% 4/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Headache	17.4% 8/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	13.6% 6/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.5% 3/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	17.0% 9/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.8% 6/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.2% 5/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	17.4% 8/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	10.9% 5/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Hypoaesthesia	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.8% 3/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.9% 1/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Migraine	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.5% 4/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.4% 3/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Paraesthesia	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 4/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	3.8% 2/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.1% 1/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.9% 2/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Sciatica	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.7% 2/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.5% 2/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 5/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	3.8% 2/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.9% 2/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Anxiety	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.5% 2/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.4% 5/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.1% 1/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.7% 4/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Depression	8.7% 4/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.8% 3/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	15.0% 6/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.3% 6/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Insomnia	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.7% 2/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	13.6% 6/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	10.0% 4/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.5% 4/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.5% 4/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Pollakiuria	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	3.8% 2/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.1% 1/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Urinary incontinence	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.7% 3/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Reproductive system and breast disorders Breast cyst	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.5% 2/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.7% 3/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.1% 1/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.9% 1/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.1% 1/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.3% 3/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Cough	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.7% 2/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.5% 2/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	10.0% 4/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.7% 3/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.4% 3/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.9% 2/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	10.9% 5/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.0% 2/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.9% 1/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.1% 1/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Nasal congestion	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	3.8% 2/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	8.7% 4/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.0% 3/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.5% 2/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.5% 4/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.3% 3/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.5% 3/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.4% 5/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.5% 3/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.7% 2/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.5% 2/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.0% 2/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.7% 3/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.1% 1/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.3% 3/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.5% 3/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	3.8% 2/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.5% 2/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.9% 1/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.1% 1/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.3% 3/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Pruritus	8.7% 4/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.5% 2/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.9% 1/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.2% 1/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Rash	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.7% 2/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.5% 2/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	10.0% 4/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	5.7% 3/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.3% 3/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	10.9% 5/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.8% 3/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	3.8% 2/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.4% 3/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Hot flush	0.00% 0/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.8% 3/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.5% 1/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	1.9% 1/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	6.5% 3/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Hypertension	4.3% 2/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.3% 4/43 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	18.2% 8/44 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 5/40 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	22.6% 12/53 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	10.6% 5/47 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	24.4% 10/41 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	8.7% 4/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	10.9% 5/46 • 48 months The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

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 multi-center studies, the investigator agrees not to publish any results before the first multi-center publication.
• Publication restrictions are in place

Restriction type: OTHER