Trial Outcomes & Findings for Denosumab (AMG 162) in Bisphosphonate Naive Metastatic Breast Cancer (NCT NCT00091832)

NCT ID: NCT00091832

Last Updated: 2014-01-28

Results Overview

Percent change from Baseline to Week 13 in Urinary N-telopeptide corrected by creatinine (uNTx/Cr) calculated using ((Week 13 value - Baseline value) / Baseline value ) x 100.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 255 participants
• Primary outcome timeframe: Baseline and Week 13
• Results posted on: 2014-01-28

Participant Flow

Participants were enrolled from 8 September 2004 through 9 May 2005

Participant milestones

Measure	Bisphosphonate IV Q4W Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion (IV)	Denosumab 30 mg Q4W Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 120 mg Q4W Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 180 mg Q4W Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 60 mg Q12W Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)	Denosumab 180 mg Q12W Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
Overall Study STARTED	43	42	42	43	42	43
Overall Study Received Study Medication	43	42	41	43	42	43
Overall Study COMPLETED	29	31	30	29	27	32
Overall Study NOT COMPLETED	14	11	12	14	15	11

Reasons for withdrawal

Measure	Bisphosphonate IV Q4W Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion (IV)	Denosumab 30 mg Q4W Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 120 mg Q4W Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 180 mg Q4W Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 60 mg Q12W Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)	Denosumab 180 mg Q12W Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
Overall Study Physician Decision	1	0	0	0	0	0
Overall Study Adverse Event	0	0	0	1	3	0
Overall Study Withdrawal by Subject	4	5	0	1	3	1
Overall Study Death	6	4	5	8	5	6
Overall Study Disease Progression	2	0	0	1	1	2
Overall Study Ineligibility Determined	0	0	1	0	1	0
Overall Study Lost to Follow-up	1	0	3	3	2	1
Overall Study Noncompliance	0	1	0	0	0	0
Overall Study Other	0	1	2	0	0	0
Overall Study Protocol Violation	0	0	1	0	0	1

Baseline Characteristics

Denosumab (AMG 162) in Bisphosphonate Naive Metastatic Breast Cancer

Baseline characteristics by cohort

Measure	Bisphosphonate IV Q4W n=43 Participants Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion	Denosumab 30 mg Q4W n=42 Participants Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 60 mg Q12W n=42 Participants Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)	Denosumab 180 mg Q12W n=43 Participants Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)	Denosumab 120 mg Q4W n=42 Participants Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 180 mg Q4W n=43 Participants Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)	Total n=255 Participants Total of all reporting groups
Age, Continuous	52.0 Years STANDARD_DEVIATION 10.7 • n=93 Participants	56.5 Years STANDARD_DEVIATION 10.8 • n=4 Participants	59.2 Years STANDARD_DEVIATION 12.3 • n=27 Participants	58.2 Years STANDARD_DEVIATION 9.1 • n=483 Participants	57.4 Years STANDARD_DEVIATION 11.0 • n=36 Participants	57.6 Years STANDARD_DEVIATION 13.9 • n=10 Participants	57.8 Years STANDARD_DEVIATION 11.4 • n=115 Participants
Sex: Female, Male Female	43 Participants n=93 Participants	42 Participants n=4 Participants	42 Participants n=27 Participants	43 Participants n=483 Participants	42 Participants n=36 Participants	43 Participants n=10 Participants	255 Participants n=115 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race/Ethnicity, Customized White or Caucasian	25 Participants n=93 Participants	28 Participants n=4 Participants	29 Participants n=27 Participants	34 Participants n=483 Participants	30 Participants n=36 Participants	33 Participants n=10 Participants	179 Participants n=115 Participants
Race/Ethnicity, Customized Hispanic or Latino	16 Participants n=93 Participants	13 Participants n=4 Participants	13 Participants n=27 Participants	9 Participants n=483 Participants	10 Participants n=36 Participants	10 Participants n=10 Participants	71 Participants n=115 Participants
Race/Ethnicity, Customized Asian	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race/Ethnicity, Customized Other	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants
uNTx/Cr	83.16 nmol/mmol STANDARD_DEVIATION 94.37 • n=93 Participants	66.44 nmol/mmol STANDARD_DEVIATION 61.17 • n=4 Participants	89.41 nmol/mmol STANDARD_DEVIATION 98.58 • n=27 Participants	75.92 nmol/mmol STANDARD_DEVIATION 91.03 • n=483 Participants	102.06 nmol/mmol STANDARD_DEVIATION 129.12 • n=36 Participants	98.22 nmol/mmol STANDARD_DEVIATION 168.42 • n=10 Participants	85.78 nmol/mmol STANDARD_DEVIATION 111.94 • n=115 Participants
Serum CTx	0.592 ng/mL STANDARD_DEVIATION 0.284 • n=93 Participants	0.632 ng/mL STANDARD_DEVIATION 0.430 • n=4 Participants	0.720 ng/mL STANDARD_DEVIATION 0.559 • n=27 Participants	0.647 ng/mL STANDARD_DEVIATION 0.703 • n=483 Participants	0.714 ng/mL STANDARD_DEVIATION 0.564 • n=36 Participants	0.846 ng/mL STANDARD_DEVIATION 0.892 • n=10 Participants	0.692 ng/mL STANDARD_DEVIATION 0.605 • n=115 Participants
TRAP 5b	6.907 U/L STANDARD_DEVIATION 3.280 • n=93 Participants	6.879 U/L STANDARD_DEVIATION 2.878 • n=4 Participants	7.116 U/L STANDARD_DEVIATION 3.493 • n=27 Participants	7.628 U/L STANDARD_DEVIATION 6.830 • n=483 Participants	6.765 U/L STANDARD_DEVIATION 4.340 • n=36 Participants	7.009 U/L STANDARD_DEVIATION 4.217 • n=10 Participants	7.057 U/L STANDARD_DEVIATION 4.358 • n=115 Participants
BSAP	54.84 U/L STANDARD_DEVIATION 51.69 • n=93 Participants	44.33 U/L STANDARD_DEVIATION 26.06 • n=4 Participants	45.62 U/L STANDARD_DEVIATION 26.02 • n=27 Participants	62.39 U/L STANDARD_DEVIATION 109.18 • n=483 Participants	47.89 U/L STANDARD_DEVIATION 30.46 • n=36 Participants	48.82 U/L STANDARD_DEVIATION 35.13 • n=10 Participants	50.75 U/L STANDARD_DEVIATION 55.04 • n=115 Participants
P1NP	111.01 µg/L STANDARD_DEVIATION 97.21 • n=93 Participants	98.54 µg/L STANDARD_DEVIATION 72.69 • n=4 Participants	114.29 µg/L STANDARD_DEVIATION 113.51 • n=27 Participants	193.03 µg/L STANDARD_DEVIATION 641.13 • n=483 Participants	98.47 µg/L STANDARD_DEVIATION 83.46 • n=36 Participants	139.01 µg/L STANDARD_DEVIATION 188.02 • n=10 Participants	126.20 µg/L STANDARD_DEVIATION 284.81 • n=115 Participants
Osleocalcin	9.42 ng/mL STANDARD_DEVIATION 5.89 • n=93 Participants	9.25 ng/mL STANDARD_DEVIATION 4.98 • n=4 Participants	10.04 ng/mL STANDARD_DEVIATION 5.70 • n=27 Participants	8.96 ng/mL STANDARD_DEVIATION 5.03 • n=483 Participants	8.09 ng/mL STANDARD_DEVIATION 3.36 • n=36 Participants	9.31 ng/mL STANDARD_DEVIATION 4.06 • n=10 Participants	9.20 ng/mL STANDARD_DEVIATION 4.93 • n=115 Participants

PRIMARY outcome

Timeframe: Baseline and Week 13

Population: Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).

Percent change from Baseline to Week 13 in Urinary N-telopeptide corrected by creatinine (uNTx/Cr) calculated using ((Week 13 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Bisphosphonate IV Q4W n=38 Participants Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion	Denosumab 30 mg Q4W n=40 Participants Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 120 mg Q4W n=38 Participants Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 180 mg Q4W n=40 Participants Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 60 mg Q12W n=38 Participants Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)	Denosumab 180 mg Q12W n=40 Participants Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
Percent Change From Baseline to Week 13 in Creatinine-adjusted Urinary N-telopeptide (uNTx/Cr)	-10.19 Percent change Standard Deviation 208.84	-52.87 Percent change Standard Deviation 95.14	-54.21 Percent change Standard Deviation 61.34	-57.36 Percent change Standard Deviation 41.46	-51.73 Percent change Standard Deviation 60.85	-18.46 Percent change Standard Deviation 125.86

SECONDARY outcome

Timeframe: Baseline and Week 25

Population: Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).

Percent change from Baseline to Week 25 in Urinary N-telopeptide (uNTx) calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.

Outcome measures

Measure	Bisphosphonate IV Q4W n=34 Participants Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion	Denosumab 30 mg Q4W n=36 Participants Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 120 mg Q4W n=34 Participants Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 180 mg Q4W n=38 Participants Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 60 mg Q12W n=32 Participants Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)	Denosumab 180 mg Q12W n=35 Participants Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
Percent Change From Baseline to Week 25 in Urinary N-telopeptide (uNTx)	-39.52 Percent change Standard Deviation 74.16	-53.46 Percent change Standard Deviation 100.77	-43.16 Percent change Standard Deviation 101.08	-59.41 Percent change Standard Deviation 43.31	-41.79 Percent change Standard Deviation 72.61	-39.96 Percent change Standard Deviation 65.85

SECONDARY outcome

Timeframe: Baseline and Week 13

Population: Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a Baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).

The number of participants achieving a 65% reduction or more in uNTx from Baseline at Week 13. Calculation used is ((Week 13 value - Baseline value) / Baseline value ) x 100 and participants were considered having a 65% reduction or more if their value was ≤ -65%.

Outcome measures

Measure	Bisphosphonate IV Q4W n=41 Participants Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion	Denosumab 30 mg Q4W n=41 Participants Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 120 mg Q4W n=40 Participants Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 180 mg Q4W n=43 Participants Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 60 mg Q12W n=42 Participants Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)	Denosumab 180 mg Q12W n=42 Participants Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
Number of Participants Achieving 65% or More Reduction in Urinary N-telopeptide (uNTx) From Baseline at Week 13	25 Participants	24 Participants	26 Participants	24 Participants	20 Participants	21 Participants

SECONDARY outcome

Timeframe: Baseline and Week 25

Population: Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).

The number of participants achieving a 65% reduction or more in uNTX from Baseline at Week 25. Calculation used is ((Week 25 value - Baseline value) / Baseline value) x 100 and participants were considered having a 65% reduction or more if their value was ≤ -65%.

Outcome measures

Measure	Bisphosphonate IV Q4W n=41 Participants Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion	Denosumab 30 mg Q4W n=41 Participants Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 120 mg Q4W n=40 Participants Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 180 mg Q4W n=43 Participants Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 60 mg Q12W n=42 Participants Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)	Denosumab 180 mg Q12W n=42 Participants Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
Number of Participants Achieving 65% or More Reduction in uNTX From Baseline at Week 25	19 Participants	25 Participants	23 Participants	25 Participants	21 Participants	15 Participants

SECONDARY outcome

Timeframe: Baseline to Week 57

Population: Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).

Kaplan-Meier estimate of the median time from enrollment to the first occurrence of a reduction of uNTx of ≥ 65% compared to Baseline. For participants whose uNTx did not fall below 65% of the Baseline value, the time was censored at time of last evaluation of uNTx.

Outcome measures

Measure	Bisphosphonate IV Q4W n=41 Participants Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion	Denosumab 30 mg Q4W n=41 Participants Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 120 mg Q4W n=40 Participants Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 180 mg Q4W n=43 Participants Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 60 mg Q12W n=42 Participants Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)	Denosumab 180 mg Q12W n=42 Participants Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
Time to 65% or More Reduction in Urinary N-telopeptide (uNTX) From Baseline	10 Days Interval 8.0 to 86.0	13 Days Interval 8.0 to 57.0	11 Days Interval 9.0 to 43.0	10 Days Interval 8.0 to 42.0	9 Days Interval 8.0 to 29.0	30 Days Interval 9.0 to 141.0

SECONDARY outcome

Timeframe: Baseline and week 13

Population: Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).

Percent change from Baseline to Week 13 in type I serum C-telopeptide (CTX) calculated using ((Week 13 value - Baseline value) / Baseline value) x 100.

Outcome measures

Measure	Bisphosphonate IV Q4W n=38 Participants Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion	Denosumab 30 mg Q4W n=39 Participants Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 120 mg Q4W n=38 Participants Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 180 mg Q4W n=40 Participants Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 60 mg Q12W n=38 Participants Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)	Denosumab 180 mg Q12W n=40 Participants Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
Percent Change From Baseline to Week 13 in Serum C-Telopeptide (CTX)	-66.92 Percent change Standard Deviation 44.05	-80.76 Percent change Standard Deviation 12.66	-78.45 Percent change Standard Deviation 28.89	-81.79 Percent change Standard Deviation 13.29	-70.50 Percent change Standard Deviation 41.76	-78.13 Percent change Standard Deviation 16.66

SECONDARY outcome

Timeframe: Baseline and Week 25

Population: Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).

Percent change from Baseline to Week 25 in type I serum C-telopeptide calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.

Outcome measures

Measure	Bisphosphonate IV Q4W n=34 Participants Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion	Denosumab 30 mg Q4W n=36 Participants Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 120 mg Q4W n=34 Participants Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 180 mg Q4W n=38 Participants Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 60 mg Q12W n=33 Participants Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)	Denosumab 180 mg Q12W n=35 Participants Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
Percent Change From Baseline to Week 25 in Serum C-telopeptide (CTX)	-73.09 Percent change Standard Deviation 22.42	-82.70 Percent change Standard Deviation 11.92	-74.48 Percent change Standard Deviation 30.26	-80.07 Percent change Standard Deviation 22.26	-70.64 Percent change Standard Deviation 36.94	-78.31 Percent change Standard Deviation 14.00

SECONDARY outcome

Timeframe: Baseline and Week 13

Population: Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).

Percent change from Baseline to Week 13 in procollagen 1 N-terminal peptide calculated using ((Week 13 value - Baseline value) / Baseline value) x 100.

Outcome measures

Measure	Bisphosphonate IV Q4W n=37 Participants Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion	Denosumab 30 mg Q4W n=39 Participants Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 120 mg Q4W n=37 Participants Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 180 mg Q4W n=40 Participants Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 60 mg Q12W n=38 Participants Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)	Denosumab 180 mg Q12W n=40 Participants Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
Percent Change From Baseline to Week 13 in Procollagen I N-terminal Peptide (P1NP)	-50.75 Percent change Standard Deviation 29.47	-52.35 Percent change Standard Deviation 36.90	-48.23 Percent change Standard Deviation 36.83	-50.47 Percent change Standard Deviation 54.67	-43.94 Percent change Standard Deviation 44.53	-59.42 Percent change Standard Deviation 18.60

SECONDARY outcome

Timeframe: Baseline and Week 25

Population: Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).

Percent change from Baseline to Week 25 in procollagen 1 N-terminal peptide (P1NP) calculated using ((Week 25 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Bisphosphonate IV Q4W n=34 Participants Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion	Denosumab 30 mg Q4W n=36 Participants Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 120 mg Q4W n=34 Participants Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 180 mg Q4W n=37 Participants Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 60 mg Q12W n=33 Participants Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)	Denosumab 180 mg Q12W n=35 Participants Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
Percent Change From Baseline to Week 25 in P1NP	-50.48 Percent change Standard Deviation 41.22	-53.48 Percent change Standard Deviation 54.79	-55.90 Percent change Standard Deviation 30.66	-57.88 Percent change Standard Deviation 51.97	-51.18 Percent change Standard Deviation 40.41	-51.37 Percent change Standard Deviation 47.53

SECONDARY outcome

Timeframe: Baseline and Week 13

Population: Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).

Percent change from Baseline to Week 13 in tartrate-resistant acid phosphatase 5b calculated using ((Week 13 value - Baseline value) / Baseline value) x 100.

Outcome measures

Measure	Bisphosphonate IV Q4W n=36 Participants Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion	Denosumab 30 mg Q4W n=38 Participants Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 120 mg Q4W n=35 Participants Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 180 mg Q4W n=37 Participants Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 60 mg Q12W n=35 Participants Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)	Denosumab 180 mg Q12W n=39 Participants Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
Percent Change From Baseline to Week 13 in Tartrate-resistant Acid Phosphatase 5b (TRAP5b)	-37.45 Percent change Standard Deviation 19.87	-56.07 Percent change Standard Deviation 17.80	-58.24 Percent change Standard Deviation 15.07	-53.12 Percent change Standard Deviation 50.00	-55.85 Percent change Standard Deviation 27.22	-55.91 Percent change Standard Deviation 17.61

SECONDARY outcome

Timeframe: Baseline and Week 25

Population: Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).

Percent change from Baseline to Week 25 in TRAP5b calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.

Outcome measures

Measure	Bisphosphonate IV Q4W n=33 Participants Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion	Denosumab 30 mg Q4W n=35 Participants Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 120 mg Q4W n=32 Participants Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 180 mg Q4W n=35 Participants Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 60 mg Q12W n=30 Participants Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)	Denosumab 180 mg Q12W n=33 Participants Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
Percent Change From Baseline to Week 25 in Tartrate-resistant Acid Phosphatase 5b (TRAP5b)	-38.59 Percent change Standard Deviation 26.06	-58.58 Percent change Standard Deviation 18.93	-52.39 Percent change Standard Deviation 25.30	-51.15 Percent change Standard Deviation 44.49	-56.25 Percent change Standard Deviation 32.30	-53.13 Percent change Standard Deviation 22.23

SECONDARY outcome

Timeframe: Baseline and Week 13

Population: Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).

Percent change from Baseline to Week 13 in bone specific alkaline phosphatase (BSAP) calculated using ((Week 13 value - Baseline value) / Baseline value) x 100.

Outcome measures

Measure	Bisphosphonate IV Q4W n=36 Participants Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion	Denosumab 30 mg Q4W n=38 Participants Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 120 mg Q4W n=35 Participants Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 180 mg Q4W n=39 Participants Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 60 mg Q12W n=37 Participants Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)	Denosumab 180 mg Q12W n=38 Participants Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
Percent Change From Baseline to Week 13 in Bone Specific Alkaline Phosphatase (BSAP)	-40.01 Percent change Standard Deviation 24.42	26.37 Percent change Standard Deviation 406.79	-40.23 Percent change Standard Deviation 27.34	-38.42 Percent change Standard Deviation 25.44	-37.11 Percent change Standard Deviation 31.33	-35.94 Percent change Standard Deviation 25.49

SECONDARY outcome

Timeframe: Baseline and Week 25

Population: Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).

Percent change from Baseline to Week 25 in BSAP calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.

Outcome measures

Measure	Bisphosphonate IV Q4W n=34 Participants Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion	Denosumab 30 mg Q4W n=35 Participants Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 120 mg Q4W n=32 Participants Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 180 mg Q4W n=35 Participants Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 60 mg Q12W n=32 Participants Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)	Denosumab 180 mg Q12W n=33 Participants Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
Percent Change From Baseline to Week 25 in Bone Specific Alkaline Phosphatase (BSAP)	-46.56 Percent change Standard Deviation 26.02	15.88 Percent change Standard Deviation 347.47	-49.01 Percent change Standard Deviation 21.24	-52.60 Percent change Standard Deviation 16.23	-46.72 Percent change Standard Deviation 23.25	-48.24 Percent change Standard Deviation 27.61

SECONDARY outcome

Timeframe: Baseline and Week 13

Population: Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).

Percent change from Baseline to Week 13 in osteocalcin calculated using ((Week 13 value - Baseline value) / Baseline value ) x 100.

Outcome measures

Measure	Bisphosphonate IV Q4W n=36 Participants Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion	Denosumab 30 mg Q4W n=38 Participants Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 120 mg Q4W n=35 Participants Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 180 mg Q4W n=39 Participants Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 60 mg Q12W n=37 Participants Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)	Denosumab 180 mg Q12W n=38 Participants Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
Percent Change From Baseline to Week 13 in Osteocalcin	6.82 Percent change Standard Deviation 49.78	-19.35 Percent change Standard Deviation 38.71	-2.39 Percent change Standard Deviation 47.96	-6.23 Percent change Standard Deviation 40.82	-23.78 Percent change Standard Deviation 35.46	-5.96 Percent change Standard Deviation 41.92

SECONDARY outcome

Timeframe: Baseline and Week 25

Population: Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).

Percent change from Baseline to Week 25 in osteocalcin calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.

Outcome measures

Measure	Bisphosphonate IV Q4W n=34 Participants Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion	Denosumab 30 mg Q4W n=35 Participants Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 120 mg Q4W n=32 Participants Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 180 mg Q4W n=35 Participants Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 60 mg Q12W n=32 Participants Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)	Denosumab 180 mg Q12W n=33 Participants Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
Percent Change From Baseline to Week 25 in Osteocalcin	-4.74 Percent change Standard Deviation 86.98	-30.78 Percent change Standard Deviation 34.94	-22.80 Percent change Standard Deviation 46.36	-26.95 Percent change Standard Deviation 41.49	-23.93 Percent change Standard Deviation 43.99	-22.69 Percent change Standard Deviation 36.79

SECONDARY outcome

Timeframe: Day 1 to Week 25

Population: All participants who were exposed to investigational product.

Skeletal Related Event (SRE) defined as ≥ 1 of the following: pathological bone fracture, spinal cord compression, surgery or radiation therapy to bone (including the use of radioisotopes).

Outcome measures

Measure	Bisphosphonate IV Q4W n=43 Participants Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion	Denosumab 30 mg Q4W n=42 Participants Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 120 mg Q4W n=41 Participants Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 180 mg Q4W n=43 Participants Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 60 mg Q12W n=42 Participants Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)	Denosumab 180 mg Q12W n=43 Participants Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
Time to First Skeletal Related Event	NA Days Median could not be calculated due to the low number of skeletal-related events	NA Days Median could not be calculated due to the low number of skeletal-related events	NA Days Median could not be calculated due to the low number of skeletal-related events	NA Days Median could not be calculated due to the low number of skeletal-related events	NA Days Median could not be calculated due to the low number of skeletal-related events	NA Days Median could not be calculated due to the low number of skeletal-related events

SECONDARY outcome

Timeframe: From Day 1 to Week 25

Population: All participants who were exposed to investigational product.

Skeletal Related Events (SRE) are defined as ≥ 1 of the following: pathological bone fracture, spinal cord compression, surgery or radiation therapy to bone (including the use of radioisotopes).

Outcome measures

Measure	Bisphosphonate IV Q4W n=43 Participants Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion	Denosumab 30 mg Q4W n=42 Participants Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 120 mg Q4W n=41 Participants Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 180 mg Q4W n=43 Participants Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 60 mg Q12W n=42 Participants Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)	Denosumab 180 mg Q12W n=43 Participants Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
Number of Participants With Skeletal Related Events	7 Participants	4 Participants	8 Participants	6 Participants	4 Participants	4 Participants

SECONDARY outcome

Timeframe: Day 1 to Week 57

Population: Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).

Occurrence of grade 3 or 4 hypercalcemia according to the Common Terminology Criteria for Adverse Events (CTCAE) v3. A summary of hypercalcemia events is reported under adverse events.

Outcome measures

Measure	Bisphosphonate IV Q4W n=41 Participants Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion	Denosumab 30 mg Q4W n=41 Participants Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 120 mg Q4W n=40 Participants Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 180 mg Q4W n=43 Participants Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 60 mg Q12W n=42 Participants Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)	Denosumab 180 mg Q12W n=42 Participants Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
Number of Participants With Hypercalcemia	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Bisphosphonate IV Q4W

Serious events: 15 serious events

Other events: 36 other events

Deaths: 0 deaths

Denosumab 30 mg Q4W

Serious events: 11 serious events

Other events: 33 other events

Deaths: 0 deaths

Denosumab 120 mg Q4W

Serious events: 19 serious events

Other events: 37 other events

Deaths: 0 deaths

Denosumab 180 mg Q4W

Serious events: 16 serious events

Other events: 36 other events

Deaths: 0 deaths

Denosumab 60 mg Q12W

Serious events: 14 serious events

Other events: 37 other events

Deaths: 0 deaths

Denosumab 180 mg Q12W

Serious events: 15 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Measure	Bisphosphonate IV Q4W n=43 participants at risk Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion.	Denosumab 30 mg Q4W n=42 participants at risk Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 120 mg Q4W n=41 participants at risk Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 180 mg Q4W n=43 participants at risk Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 60 mg Q12W n=42 participants at risk Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)	Denosumab 180 mg Q12W n=43 participants at risk Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
Respiratory, thoracic and mediastinal disorders Respiratory arrest	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Surgical and medical procedures Internal fixation of fracture	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Anaemia	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.3% 3/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.8% 2/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Febrile bone marrow aplasia	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Febrile neutropenia	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.9% 2/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.1% 3/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Leukopenia	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Neutropenia	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Angina pectoris	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiac tamponade	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiopulmonary failure	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Pericardial effusion	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Macular oedema	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Vitreous haemorrhage	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal pain	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Diarrhoea	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Ileus	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Nausea	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.7% 2/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Oesophagitis	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Vomiting	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.9% 2/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Asthenia	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Gait disturbance	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders General physical health deterioration	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.3% 4/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Mucosal inflammation	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Multi-organ failure	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Oedema peripheral	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Pain	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Pyrexia	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.9% 2/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Cholelithiasis	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Hepatic cirrhosis	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Hepatic failure	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Liver disorder	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Catheter related infection	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Cellulitis	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Central line infection	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Escherichia bacteraemia	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Escherichia sepsis	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Gastroenteritis	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Lobar pneumonia	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Neurocysticercosis	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pneumonia	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Sepsis	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Septic shock	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Sinusitis	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Urinary tract infection	4.7% 2/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Femur fracture	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Therapeutic agent toxicity	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Karnofsky scale worsened	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Anorexia	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Cachexia	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.7% 2/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Dehydration	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.7% 2/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Malnutrition	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Metabolic alkalosis	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Arthralgia	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Myalgia	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks 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	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks 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 metastatic	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks 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) Cancer pain	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks 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 neoplasm progression	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks 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) Metastases to bone	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks 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) Metastases to central nervous system	4.7% 2/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks 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) Metastases to liver	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks 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) Metastases to lung	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks 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) Recurrent cancer	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks 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) Tongue neoplasm malignant stage unspecified	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Cerebral haemorrhage	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Cervicobrachial syndrome	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Facial palsy	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Facial paresis	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Headache	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Hemiplegia	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Intracranial pressure increased	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Peripheral motor neuropathy	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Vocal cord paralysis	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Renal failure acute	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Urinary retention	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.9% 2/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnoea exacerbated	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pleural effusion	4.7% 2/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.3% 3/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.5% 4/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary thrombosis	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory alkalosis	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Hypotension	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Lymphoedema	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Secondary hypertension	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Venous thrombosis	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Other adverse events

Measure	Bisphosphonate IV Q4W n=43 participants at risk Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion.	Denosumab 30 mg Q4W n=42 participants at risk Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 120 mg Q4W n=41 participants at risk Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 180 mg Q4W n=43 participants at risk Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)	Denosumab 60 mg Q12W n=42 participants at risk Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)	Denosumab 180 mg Q12W n=43 participants at risk Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
Blood and lymphatic system disorders Anaemia	4.7% 2/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.8% 2/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.3% 3/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.7% 2/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 7/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.6% 5/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Neutropenia	7.0% 3/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.7% 2/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.1% 3/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.7% 2/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Palpitations	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.3% 3/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal pain	9.3% 4/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.1% 3/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.3% 4/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.8% 2/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.0% 3/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal pain upper	7.0% 3/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.1% 3/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.1% 3/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Constipation	16.3% 7/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 7/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.2% 5/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	14.0% 6/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.5% 4/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.3% 4/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Diarrhoea	16.3% 7/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	21.4% 9/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	22.0% 9/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	14.0% 6/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.5% 4/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	14.0% 6/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Dry mouth	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.0% 3/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gastritis	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.8% 2/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.1% 3/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Nausea	23.3% 10/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	23.8% 10/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	22.0% 9/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	25.6% 11/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 7/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	20.9% 9/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Vomiting	18.6% 8/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	26.2% 11/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	17.1% 7/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.6% 5/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 7/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.3% 4/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Asthenia	27.9% 12/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	21.4% 9/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	22.0% 9/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.3% 4/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	14.3% 6/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.6% 5/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Fatigue	11.6% 5/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 7/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.2% 5/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.6% 5/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	14.3% 6/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.6% 5/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Injection site pain	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.0% 3/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Mucosal inflammation	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.1% 3/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.1% 3/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Oedema peripheral	11.6% 5/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.8% 2/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.0% 3/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.8% 2/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	14.0% 6/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Pain	4.7% 2/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.1% 3/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.0% 3/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.1% 3/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.7% 2/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Pyrexia	18.6% 8/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.8% 2/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.8% 4/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.0% 3/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.1% 3/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.0% 3/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Influenza	7.0% 3/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.8% 2/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Nasopharyngitis	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.9% 2/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.7% 2/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.6% 5/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Anorexia	7.0% 3/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	14.3% 6/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.3% 3/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.6% 5/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.1% 3/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hypocalcaemia	7.0% 3/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Arthralgia	27.9% 12/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.1% 3/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.8% 4/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	20.9% 9/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.9% 5/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.0% 3/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Back pain	9.3% 4/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 7/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	22.0% 9/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.6% 5/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.5% 4/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.6% 5/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Bone pain	18.6% 8/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.8% 2/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	17.1% 7/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	14.0% 6/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.9% 5/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.3% 4/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Muscle spasms	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.8% 2/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.9% 2/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.0% 3/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.3% 3/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.8% 4/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.0% 3/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.7% 2/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Myalgia	20.9% 9/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.1% 3/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.7% 2/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Pain in extremity	18.6% 8/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	14.3% 6/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.8% 4/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	14.0% 6/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.8% 2/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.7% 2/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Pathological fracture	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.0% 3/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Shoulder pain	7.0% 3/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.9% 2/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.7% 2/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.0% 3/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Dizziness	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.9% 2/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.1% 3/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Headache	16.3% 7/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.5% 4/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	14.6% 6/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	14.0% 6/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	19.0% 8/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.3% 4/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Lethargy	4.7% 2/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.8% 4/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Neuralgia	7.0% 3/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Paraesthesia	9.3% 4/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.3% 3/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.0% 3/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.1% 3/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Depression	7.0% 3/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.8% 2/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.9% 2/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.8% 2/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Insomnia	4.7% 2/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.3% 3/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.9% 5/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Cough	16.3% 7/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	11.9% 5/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.2% 5/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.7% 2/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.1% 3/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.7% 2/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnoea	11.6% 5/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.3% 3/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.0% 3/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	7.0% 3/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	7.0% 3/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Alopecia	7.0% 3/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.1% 3/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.9% 2/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.0% 3/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.1% 3/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.0% 3/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	4.7% 2/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.1% 3/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.7% 2/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.4% 1/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.0% 3/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Surgical and medical procedures Radiotherapy to bone	7.0% 3/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.8% 2/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.3% 3/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.7% 2/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.8% 2/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Hot flush	4.7% 2/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.1% 3/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.2% 5/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.8% 2/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.7% 2/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Hypertension	7.0% 3/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.8% 2/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/41 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	4.7% 2/43 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	7.1% 3/42 • 25 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	2.3% 1/43 • 25 weeks 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