Trial Outcomes & Findings for Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma (NCT NCT01239797)

NCT ID: NCT01239797

Last Updated: 2022-06-01

Results Overview

Primary definition of Progression-free survival (PFS) defined as the time from randomization to the date of first documented tumor progression or death due to any cause. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (\> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. The primary analysis of PFS was based on the primary definition using the Independent Review Committee (IRC) tumor assessment using the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Tumor assessments were made every 4 weeks (±1 week) relative to the first dose of study medication.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 646 participants
• Primary outcome timeframe: From randomization up to 326 events (up to approximately 38 months)
• Results posted on: 2022-06-01

Participant Flow

646 participants were randomized and 635 were treated

Participant milestones

Measure	Lenalidomide + Dexamethasone + Elotuzumab Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1\&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug	Lenalidomide + Dexamethasone Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
Randomized Participants STARTED	321	325
Randomized Participants COMPLETED	319	316
Randomized Participants NOT COMPLETED	2	9
Treated Participants STARTED	318	317
Treated Participants COMPLETED	0	0
Treated Participants NOT COMPLETED	318	317

Reasons for withdrawal

Measure	Lenalidomide + Dexamethasone + Elotuzumab Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1\&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug	Lenalidomide + Dexamethasone Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
Randomized Participants Participant no longer meets study criteria	1	1
Randomized Participants Participant withdrew consent	1	7
Randomized Participants Adverse event unrelated to study drug	0	1
Treated Participants Disease progression	185	185
Treated Participants Study drug toxicity	39	45
Treated Participants Adverse event unrelated to study drug	31	37
Treated Participants Participants request to discontinue study treatment	28	18
Treated Participants Administrative reason by sponsor	13	4
Treated Participants Other reasons	14	14
Treated Participants Participant withdrew consent	6	11
Treated Participants Death	1	1
Treated Participants Participant no longer meets study criteria	1	1
Treated Participants Poor/non-compliance	0	1

Baseline Characteristics

Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma

Baseline characteristics by cohort

Measure	Lenalidomide + Dexamethasone + Elotuzumab n=321 Participants Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1\&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug	Lenalidomide + Dexamethasone n=325 Participants Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug	Total n=646 Participants Total of all reporting groups
Age, Continuous	66.2 years STANDARD_DEVIATION 9.34 • n=5 Participants	65.3 years STANDARD_DEVIATION 10.26 • n=7 Participants	65.7 years STANDARD_DEVIATION 9.81 • n=5 Participants
Age, Customized < 65 years old	134 Participants n=5 Participants	142 Participants n=7 Participants	276 Participants n=5 Participants
Age, Customized >= 65 and < 75 years old	119 Participants n=5 Participants	122 Participants n=7 Participants	241 Participants n=5 Participants
Age, Customized >= 75 years old	68 Participants n=5 Participants	61 Participants n=7 Participants	129 Participants n=5 Participants
Sex: Female, Male Female	129 Participants n=5 Participants	132 Participants n=7 Participants	261 Participants n=5 Participants
Sex: Female, Male Male	192 Participants n=5 Participants	193 Participants n=7 Participants	385 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants	33 Participants n=7 Participants	61 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	288 Participants n=5 Participants	291 Participants n=7 Participants	579 Participants n=5 Participants
Race/Ethnicity, Customized White	264 Participants n=5 Participants	280 Participants n=7 Participants	544 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	33 Participants n=5 Participants	31 Participants n=7 Participants	64 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization up to 326 events (up to approximately 38 months)

Population: All randomized participants

Primary definition of Progression-free survival (PFS) defined as the time from randomization to the date of first documented tumor progression or death due to any cause. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. The primary analysis of PFS was based on the primary definition using the Independent Review Committee (IRC) tumor assessment using the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Tumor assessments were made every 4 weeks (±1 week) relative to the first dose of study medication.

Outcome measures

Measure	Lenalidomide + Dexamethasone + Elotuzumab n=321 Participants Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1\&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug	Lenalidomide + Dexamethasone n=325 Participants Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
Median Progression Free Survival (PFS)	19.35 Months Interval 16.62 to 22.18	14.85 Months Interval 12.09 to 17.22

PRIMARY outcome

Timeframe: From randomization up to approximately 38 months

Population: All randomized participants

Objective response rate (ORR) defined as the percentage of participants with a best response on-study of partial response (PR) or better (stringent CR [sCR], complete response [CR], very good partial response [VGPR], and partial response [PR]) based on the Independent Review Committee (IRC) assessment of best response using the European Group for Blood and Bone Marrow Transplant (EBMT) assessment criteria. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. Assessments were made every 4 weeks.

Outcome measures

Measure	Lenalidomide + Dexamethasone + Elotuzumab n=321 Participants Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1\&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug	Lenalidomide + Dexamethasone n=325 Participants Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
Objective Response Rate (ORR)	78.5 Percentage of participants Interval 73.6 to 82.9	65.5 Percentage of participants Interval 60.1 to 70.7

SECONDARY outcome

Timeframe: Randomization to the date of death from any cause (up to approximately 9 years)

Population: All randomized participants

Overall survival is defined as the time from randomization to the date of death from any cause. If a subject has not died, their survival time will be censored at the date of last contact ("last known alive date"). A subject will be censored at the date of randomization if they were randomized but had no follow-up. (Based on Kaplan Meier estimates)

Outcome measures

Measure	Lenalidomide + Dexamethasone + Elotuzumab n=321 Participants Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1\&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug	Lenalidomide + Dexamethasone n=325 Participants Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
Median Overall Survival (OS)	48.30 Months Interval 40.34 to 51.94	39.62 Months Interval 33.25 to 45.27

SECONDARY outcome

Timeframe: From baseline up to approximately 38 months

Population: All randomized participants with baseline and end of treatment scores

The change from baseline of the mean score of pain severity at the end of treatment using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF is a self administered questionnaire developed to assess the severity of pain (the sensory dimension) as well as the degree to which pain interferes with function (the reactive dimension). The BPI-SF uses 0 ("No pain", "No interference") to 10 ("Pain as bad as you can imagine", "Highest imaginable interference") numeric rating scale.

Outcome measures

Measure	Lenalidomide + Dexamethasone + Elotuzumab n=114 Participants Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1\&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug	Lenalidomide + Dexamethasone n=152 Participants Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
Change From Baseline of Mean Score Pain Severity (BPI-SF)	0.52 Score on a scale Standard Deviation 2.237	-0.04 Score on a scale Standard Deviation 2.408

SECONDARY outcome

Timeframe: From baseline up to approximately 38 months

Population: All randomized participants with baseline and end of treatment scores

The change from baseline of the mean score of pain interference at the end of treatment using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF is a self administered questionnaire developed to assess the severity of pain (the sensory dimension) as well as the degree to which pain interferes with function (the reactive dimension). The BPI-SF uses 0 ("No pain", "No interference") to 10 ("Pain as bad as you can imagine", "Highest imaginable interference") numeric rating scale.

Outcome measures

Measure	Lenalidomide + Dexamethasone + Elotuzumab n=113 Participants Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1\&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug	Lenalidomide + Dexamethasone n=150 Participants Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
Change From Baseline of Mean Score Pain Interference (BPI-SF)	0.95 Score on a scale Standard Deviation 2.466	0.48 Score on a scale Standard Deviation 2.868

POST_HOC outcome

Timeframe: From randomization up to to the date of first documented tumor progression or death (up to approximately 85 months)

Population: All randomized participants

The time from randomization to the date of first documented tumor progression or death due to any cause. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. Tumor assessments were made every 4 weeks (±1 week) relative to the first dose of study medication based on Independent Review Committee (IRC) tumor assessment using the European Group for Blood and Bone Marrow Transplant (EBMT) criteria.

Note: This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date. (Assessments were made until 06-Jul-2018)

Outcome measures

Measure	Lenalidomide + Dexamethasone + Elotuzumab n=321 Participants Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1\&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug	Lenalidomide + Dexamethasone n=325 Participants Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
Median Progression Free Survival (PFS) - Extended Collection	19.42 Months Interval 16.62 to 22.31	14.92 Months Interval 12.25 to 17.31

Adverse Events

Lenalidomide + Dexamethasone + Elotuzumab

Serious events: 238 serious events

Other events: 314 other events

Deaths: 226 deaths

Lenalidomide + Dexamethasone

Serious events: 194 serious events

Other events: 309 other events

Deaths: 249 deaths

Serious adverse events

Measure	Lenalidomide + Dexamethasone + Elotuzumab n=318 participants at risk Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1\&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug	Lenalidomide + Dexamethasone n=317 participants at risk Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
Blood and lymphatic system disorders Anaemia	3.5% 11/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	2.5% 8/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Blood and lymphatic system disorders Bone marrow failure	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Blood and lymphatic system disorders Eosinophilia	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Blood and lymphatic system disorders Febrile neutropenia	1.6% 5/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	1.3% 4/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Blood and lymphatic system disorders Microangiopathic haemolytic anaemia	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Blood and lymphatic system disorders Neutropenia	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	1.3% 4/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Blood and lymphatic system disorders Pancytopenia	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Blood and lymphatic system disorders Splenic infarction	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Blood and lymphatic system disorders Thrombocytopenia	1.6% 5/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.63% 2/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Cardiac disorders Acute coronary syndrome	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.63% 2/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Cardiac disorders Acute left ventricular failure	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Cardiac disorders Acute myocardial infarction	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.63% 2/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Cardiac disorders Angina pectoris	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Cardiac disorders Angina unstable	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Cardiac disorders Arrhythmia	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Cardiac disorders Atrial fibrillation	1.9% 6/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	2.8% 9/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Cardiac disorders Atrioventricular block complete	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Cardiac disorders Brugada syndrome	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Cardiac disorders Cardiac aneurysm	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Cardiac disorders Cardiac arrest	0.94% 3/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Cardiac disorders Cardiac failure	0.94% 3/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.95% 3/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Cardiac disorders Cardiac failure congestive	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Cardiac disorders Cardio-respiratory arrest	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Cardiac disorders Cardiogenic shock	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Cardiac disorders Left ventricular failure	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Cardiac disorders Myocardial infarction	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.95% 3/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Cardiac disorders Myocardial ischaemia	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.63% 2/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Cardiac disorders Pericarditis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Cardiac disorders Sinus node dysfunction	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Cardiac disorders Supraventricular tachycardia	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Endocrine disorders Hypothyroidism	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Eye disorders Cataract	1.9% 6/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	1.9% 6/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Eye disorders Cataract nuclear	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Eye disorders Visual impairment	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Abdominal pain	0.94% 3/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Abdominal pain upper	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Colitis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.63% 2/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Constipation	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.63% 2/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Diarrhoea	2.2% 7/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	3.8% 12/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Diverticulum	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Enteritis	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Enterocolitis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Enterocutaneous fistula	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Gastric haemorrhage	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Gastric ulcer	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Haemorrhoids	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Hiatus hernia	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Ileus	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Ileus paralytic	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Inguinal hernia	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Inguinal hernia, obstructive	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Intestinal haemorrhage	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Intestinal ischaemia	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Intestinal obstruction	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Large intestinal ulcer	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Large intestine perforation	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Mouth haemorrhage	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Nausea	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Pancreatitis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Pancreatitis acute	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Rectal haemorrhage	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Subileus	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Vomiting	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	1.3% 4/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
General disorders Asthenia	1.3% 4/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
General disorders Chest pain	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
General disorders Chills	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
General disorders Death	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
General disorders Disease progression	4.7% 15/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	3.2% 10/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
General disorders Fatigue	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
General disorders General physical health deterioration	1.6% 5/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	1.3% 4/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
General disorders Hernia	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
General disorders Malaise	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
General disorders Multiple organ dysfunction syndrome	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
General disorders Pain	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
General disorders Pyrexia	7.9% 25/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	5.4% 17/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Hepatobiliary disorders Cholangitis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Hepatobiliary disorders Cholecystitis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Hepatobiliary disorders Cholecystitis acute	1.3% 4/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Hepatobiliary disorders Cholecystitis chronic	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Hepatobiliary disorders Cholelithiasis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Hepatobiliary disorders Hepatic failure	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Hepatobiliary disorders Hepatitis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Hepatobiliary disorders Hyperbilirubinaemia	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Immune system disorders Haemophagocytic lymphohistiocytosis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Abdominal abscess	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Abscess oral	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Acute sinusitis	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Appendicitis	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Arthritis bacterial	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.63% 2/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Atypical pneumonia	0.94% 3/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Bacteraemia	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Bacterial sepsis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Biliary sepsis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Brain abscess	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Bronchitis	2.5% 8/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	2.5% 8/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Bronchopulmonary aspergillosis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Bursitis infective	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Campylobacter gastroenteritis	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Catheter site abscess	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Cellulitis	2.5% 8/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Cerebral aspergillosis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Clostridium colitis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Clostridium difficile colitis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Clostridium difficile infection	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Cytomegalovirus chorioretinitis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Cytomegalovirus infection	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Device related infection	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Device related sepsis	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Diverticulitis	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Endocarditis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.63% 2/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Enteritis infectious	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Enterocolitis viral	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Epididymitis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Escherichia urinary tract infection	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Febrile infection	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Gastroenteritis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.63% 2/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Gastroenteritis clostridial	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Gastroenteritis norovirus	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Gastroenteritis viral	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	1.3% 4/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Genital abscess	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations H1N1 influenza	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Hepatitis B	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Herpes zoster	1.3% 4/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Herpes zoster reactivation	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Infection	0.94% 3/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Influenza	0.94% 3/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	1.3% 4/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Intervertebral discitis	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Large intestine infection	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Listeriosis	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Localised infection	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Lower respiratory tract infection	2.5% 8/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	1.3% 4/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Lung abscess	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Meningitis staphylococcal	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Metapneumovirus infection	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Neutropenic sepsis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Ophthalmic herpes zoster	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Osteomyelitis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Otitis media chronic	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Parvovirus B19 infection	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Periodontitis	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Peritonitis	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Pharyngitis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.63% 2/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Pneumococcal sepsis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Pneumocystis jirovecii pneumonia	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Pneumonia	17.6% 56/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	12.6% 40/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Pneumonia bacterial	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Pneumonia fungal	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Pneumonia influenzal	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.63% 2/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Pneumonia pneumococcal	0.94% 3/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Post procedural infection	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Pseudomonal sepsis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Pseudomonas infection	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Pulmonary sepsis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Pyelonephritis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Pyelonephritis acute	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Respiratory syncytial virus infection	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Respiratory tract infection	3.5% 11/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	1.3% 4/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Retinitis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Rotavirus infection	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Sepsis	1.6% 5/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	2.5% 8/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Septic shock	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	1.6% 5/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Sinusitis	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Skin infection	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Staphylococcal sepsis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Streptococcal bacteraemia	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Systemic infection	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Tooth abscess	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Upper respiratory tract infection	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Urinary tract infection	0.94% 3/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	1.6% 5/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Urinary tract infection enterococcal	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Urosepsis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Varicella zoster virus infection	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Viral diarrhoea	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Viral infection	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Wound infection	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Injury, poisoning and procedural complications Accidental overdose	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Injury, poisoning and procedural complications Chemical burn	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Injury, poisoning and procedural complications Compression fracture	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.63% 2/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Injury, poisoning and procedural complications Fall	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Injury, poisoning and procedural complications Femoral neck fracture	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Injury, poisoning and procedural complications Femur fracture	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Injury, poisoning and procedural complications Hip fracture	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.63% 2/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Injury, poisoning and procedural complications Humerus fracture	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Injury, poisoning and procedural complications Ilium fracture	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Injury, poisoning and procedural complications Joint dislocation	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Injury, poisoning and procedural complications Limb injury	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Injury, poisoning and procedural complications Lip injury	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Injury, poisoning and procedural complications Overdose	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Injury, poisoning and procedural complications Pelvic fracture	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.63% 2/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.63% 2/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Nervous system disorders Syncope	0.94% 3/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.63% 2/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Injury, poisoning and procedural complications Rib fracture	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Injury, poisoning and procedural complications Seroma	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Injury, poisoning and procedural complications Soft tissue injury	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Injury, poisoning and procedural complications Spinal compression fracture	0.94% 3/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Injury, poisoning and procedural complications Spinal fracture	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Injury, poisoning and procedural complications Stenosis of vesicourethral anastomosis	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Injury, poisoning and procedural complications Traumatic fracture	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.63% 2/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Injury, poisoning and procedural complications Upper limb fracture	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Investigations Blood creatinine increased	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Investigations Clostridium test positive	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Investigations Escherichia test positive	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Investigations General physical condition abnormal	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Investigations Haemoglobin decreased	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Investigations Hepatic enzyme increased	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Investigations Influenza A virus test positive	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Investigations Influenza B virus test positive	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Investigations International normalised ratio increased	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Investigations Liver function test abnormal	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Investigations Polymerase chain reaction positive	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Investigations Viral test positive	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Metabolism and nutrition disorders Decreased appetite	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Metabolism and nutrition disorders Dehydration	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Metabolism and nutrition disorders Diabetes mellitus	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Metabolism and nutrition disorders Failure to thrive	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Metabolism and nutrition disorders Fluid retention	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Metabolism and nutrition disorders Hypercalcaemia	0.94% 3/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.63% 2/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Metabolism and nutrition disorders Hyperglycaemia	0.94% 3/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Metabolism and nutrition disorders Hypokalaemia	0.94% 3/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.63% 2/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Metabolism and nutrition disorders Ketoacidosis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Musculoskeletal and connective tissue disorders Arthralgia	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.63% 2/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Musculoskeletal and connective tissue disorders Arthritis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Musculoskeletal and connective tissue disorders Back pain	2.2% 7/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	1.6% 5/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Musculoskeletal and connective tissue disorders Bone cyst	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Musculoskeletal and connective tissue disorders Bone lesion	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Musculoskeletal and connective tissue disorders Bone pain	0.94% 3/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Musculoskeletal and connective tissue disorders Exostosis	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Musculoskeletal and connective tissue disorders Muscle mass	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Musculoskeletal and connective tissue disorders Muscular weakness	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	1.9% 6/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Musculoskeletal and connective tissue disorders Pain in extremity	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.95% 3/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Musculoskeletal and connective tissue disorders Tendonitis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute erythroid leukaemia	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Atypical fibroxanthoma	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	3.1% 10/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	1.3% 4/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage I	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenocarcinoma	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) External ear neoplasm malignant	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal neoplasm	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma of bone	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip squamous cell carcinoma	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	1.3% 4/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of unknown primary site	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	1.6% 5/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	1.3% 4/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesothelioma	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.95% 3/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	1.9% 6/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	1.6% 5/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma recurrent	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasmacytoma	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.95% 3/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.63% 2/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Nervous system disorders Transient ischaemic attack	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sarcoma	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.95% 3/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	3.8% 12/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.95% 3/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vulval cancer	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Nervous system disorders Cerebral haemorrhage	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Nervous system disorders Cerebral infarction	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Nervous system disorders Cerebral ischaemia	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Nervous system disorders Cerebrospinal fluid leakage	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Nervous system disorders Cerebrovascular accident	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.95% 3/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Nervous system disorders Dementia	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Nervous system disorders Dizziness	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Nervous system disorders Encephalopathy	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.63% 2/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Nervous system disorders Hemiparesis	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Nervous system disorders Hepatic encephalopathy	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Nervous system disorders Hypoaesthesia	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Nervous system disorders Ischaemic stroke	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Nervous system disorders Nervous system disorder	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Nervous system disorders Neuropathy peripheral	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Nervous system disorders Optic neuritis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Nervous system disorders Paraesthesia	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Nervous system disorders Paraparesis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Nervous system disorders Presyncope	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Nervous system disorders Sciatica	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Nervous system disorders Seizure	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Nervous system disorders Somnolence	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Nervous system disorders Spinal cord compression	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.63% 2/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Nervous system disorders Spinal cord disorder	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Nervous system disorders Status epilepticus	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Product Issues Device dislocation	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Psychiatric disorders Completed suicide	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Psychiatric disorders Confusional state	1.3% 4/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Psychiatric disorders Delirium	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Psychiatric disorders Depression	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Psychiatric disorders Mental status changes	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Renal and urinary disorders Acute kidney injury	3.5% 11/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	2.5% 8/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Renal and urinary disorders Haematuria	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Renal and urinary disorders Haemorrhage urinary tract	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Renal and urinary disorders Myeloma cast nephropathy	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Renal and urinary disorders Nephrolithiasis	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Renal and urinary disorders Neurogenic bladder	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Renal and urinary disorders Prerenal failure	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Renal and urinary disorders Renal failure	1.3% 4/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	1.6% 5/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Renal and urinary disorders Renal impairment	0.94% 3/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Renal and urinary disorders Renal tubular acidosis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Renal and urinary disorders Urinary retention	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.95% 3/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Renal and urinary disorders Urinary tract obstruction	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Respiratory, thoracic and mediastinal disorders Asthma	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Respiratory, thoracic and mediastinal disorders Bronchial disorder	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.6% 5/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.95% 3/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Respiratory, thoracic and mediastinal disorders Cough	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.3% 4/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	1.3% 4/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.95% 3/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Respiratory, thoracic and mediastinal disorders Lung disorder	1.3% 4/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Respiratory, thoracic and mediastinal disorders Obliterative bronchiolitis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.63% 2/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Respiratory, thoracic and mediastinal disorders Pulmonary alveolar haemorrhage	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Respiratory, thoracic and mediastinal disorders Pulmonary artery thrombosis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.5% 11/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	2.5% 8/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.63% 2/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Skin and subcutaneous tissue disorders Dermal cyst	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Skin and subcutaneous tissue disorders Pustular psoriasis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Skin and subcutaneous tissue disorders Skin haemorrhage	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Surgical and medical procedures Hip arthroplasty	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Vascular disorders Aortic aneurysm rupture	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Vascular disorders Deep vein thrombosis	3.1% 10/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	1.3% 4/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Vascular disorders Embolism	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Vascular disorders Hypotension	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Vascular disorders Hypovolaemic shock	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Vascular disorders Orthostatic hypotension	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Vascular disorders Pelvic venous thrombosis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Vascular disorders Peripheral artery thrombosis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Vascular disorders Peripheral ischaemia	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Vascular disorders Subclavian vein thrombosis	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Vascular disorders Thrombophlebitis	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.63% 2/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Vascular disorders Thrombophlebitis superficial	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Vascular disorders Thrombosis	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.32% 1/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Vascular disorders Venous thrombosis	0.00% 0/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.63% 2/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Vascular disorders Venous thrombosis limb	0.31% 1/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	0.00% 0/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.

Other adverse events

Measure	Lenalidomide + Dexamethasone + Elotuzumab n=318 participants at risk Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1\&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug	Lenalidomide + Dexamethasone n=317 participants at risk Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
Investigations Alanine aminotransferase increased	7.9% 25/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	10.4% 33/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Investigations Aspartate aminotransferase increased	6.6% 21/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	9.8% 31/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Blood and lymphatic system disorders Anaemia	42.5% 135/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	37.2% 118/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Blood and lymphatic system disorders Leukopenia	8.2% 26/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	8.2% 26/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Blood and lymphatic system disorders Lymphopenia	12.9% 41/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	7.3% 23/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Blood and lymphatic system disorders Neutropenia	35.8% 114/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	43.2% 137/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Blood and lymphatic system disorders Thrombocytopenia	28.6% 91/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	22.7% 72/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Eye disorders Cataract	18.2% 58/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	11.4% 36/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Eye disorders Vision blurred	9.7% 31/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	5.7% 18/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Abdominal pain	13.8% 44/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	9.8% 31/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Abdominal pain upper	9.4% 30/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	6.3% 20/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Constipation	36.2% 115/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	28.1% 89/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Diarrhoea	50.0% 159/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	38.5% 122/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Dry mouth	5.0% 16/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	3.2% 10/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Dyspepsia	11.3% 36/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	6.0% 19/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Nausea	25.8% 82/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	23.0% 73/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Stomatitis	9.4% 30/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	4.4% 14/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Toothache	5.7% 18/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	3.5% 11/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Gastrointestinal disorders Vomiting	18.2% 58/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	10.1% 32/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
General disorders Asthenia	25.2% 80/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	17.0% 54/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
General disorders Chest pain	8.8% 28/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	4.4% 14/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
General disorders Chills	9.7% 31/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	3.8% 12/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
General disorders Fatigue	48.4% 154/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	41.3% 131/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
General disorders Influenza like illness	8.5% 27/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	5.0% 16/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
General disorders Malaise	6.0% 19/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	3.8% 12/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
General disorders Oedema peripheral	30.5% 97/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	24.6% 78/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
General disorders Pain	5.3% 17/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	2.2% 7/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
General disorders Pyrexia	38.1% 121/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	23.3% 74/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Bronchitis	20.8% 66/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	16.4% 52/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Gastroenteritis	5.7% 18/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	2.8% 9/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Herpes zoster	5.7% 18/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	1.6% 5/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Influenza	7.9% 25/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	5.4% 17/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Lower respiratory tract infection	10.1% 32/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	5.0% 16/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Nasopharyngitis	26.1% 83/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	18.9% 60/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Oral herpes	6.3% 20/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	4.1% 13/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Pharyngitis	5.3% 17/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	5.0% 16/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Pneumonia	9.4% 30/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	7.3% 23/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Respiratory tract infection	11.3% 36/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	10.1% 32/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Rhinitis	9.4% 30/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	4.1% 13/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Sinusitis	7.2% 23/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	4.7% 15/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Upper respiratory tract infection	27.0% 86/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	19.6% 62/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Urinary tract infection	11.3% 36/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	9.8% 31/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Infections and infestations Viral infection	5.7% 18/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	3.2% 10/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Injury, poisoning and procedural complications Contusion	13.8% 44/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	8.8% 28/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Injury, poisoning and procedural complications Fall	6.6% 21/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	4.4% 14/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Investigations Blood creatinine increased	11.3% 36/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	8.5% 27/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Investigations C-reactive protein increased	4.1% 13/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	5.0% 16/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Investigations Platelet count decreased	5.0% 16/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	1.6% 5/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Investigations Weight decreased	16.4% 52/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	6.3% 20/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Metabolism and nutrition disorders Decreased appetite	22.3% 71/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	13.2% 42/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Metabolism and nutrition disorders Hyperglycaemia	19.2% 61/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	14.2% 45/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Metabolism and nutrition disorders Hypoalbuminaemia	5.3% 17/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	3.5% 11/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Metabolism and nutrition disorders Hypocalcaemia	15.1% 48/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	8.8% 28/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Metabolism and nutrition disorders Hypokalaemia	21.1% 67/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	14.8% 47/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Metabolism and nutrition disorders Hypomagnesaemia	6.9% 22/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	1.6% 5/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Metabolism and nutrition disorders Hyponatraemia	5.7% 18/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	3.2% 10/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Metabolism and nutrition disorders Hypophosphataemia	6.0% 19/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	3.2% 10/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Musculoskeletal and connective tissue disorders Arthralgia	30.8% 98/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	19.9% 63/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Musculoskeletal and connective tissue disorders Back pain	33.0% 105/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	30.6% 97/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Musculoskeletal and connective tissue disorders Bone pain	10.4% 33/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	13.6% 43/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Musculoskeletal and connective tissue disorders Muscle spasms	31.1% 99/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	26.8% 85/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Musculoskeletal and connective tissue disorders Muscular weakness	13.2% 42/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	8.8% 28/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	12.3% 39/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	9.5% 30/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Musculoskeletal and connective tissue disorders Myalgia	8.2% 26/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	6.9% 22/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Musculoskeletal and connective tissue disorders Neck pain	7.2% 23/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	4.1% 13/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Musculoskeletal and connective tissue disorders Pain in extremity	20.1% 64/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	11.0% 35/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Nervous system disorders Dizziness	15.1% 48/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	12.0% 38/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Nervous system disorders Headache	17.0% 54/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	9.1% 29/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Nervous system disorders Hypoaesthesia	8.8% 28/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	3.8% 12/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Nervous system disorders Neuropathy peripheral	16.0% 51/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	9.8% 31/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Nervous system disorders Paraesthesia	11.0% 35/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	9.1% 29/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Nervous system disorders Peripheral sensory neuropathy	10.4% 33/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	12.3% 39/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Nervous system disorders Taste disorder	5.7% 18/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	4.4% 14/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Nervous system disorders Tremor	9.4% 30/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	9.1% 29/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Psychiatric disorders Anxiety	8.2% 26/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	7.6% 24/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Psychiatric disorders Confusional state	5.7% 18/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	3.2% 10/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Psychiatric disorders Depression	5.7% 18/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	4.4% 14/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Psychiatric disorders Insomnia	24.8% 79/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	26.2% 83/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Psychiatric disorders Mood altered	7.2% 23/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	2.5% 8/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Renal and urinary disorders Dysuria	5.0% 16/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	2.8% 9/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Respiratory, thoracic and mediastinal disorders Cough	34.3% 109/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	19.6% 62/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Respiratory, thoracic and mediastinal disorders Dysphonia	7.9% 25/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	10.1% 32/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Respiratory, thoracic and mediastinal disorders Dyspnoea	22.6% 72/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	18.9% 60/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	6.3% 20/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	4.7% 15/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Respiratory, thoracic and mediastinal disorders Epistaxis	6.9% 22/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	6.0% 19/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	10.1% 32/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	4.7% 15/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Respiratory, thoracic and mediastinal disorders Productive cough	7.9% 25/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	1.6% 5/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Skin and subcutaneous tissue disorders Erythema	8.2% 26/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	5.0% 16/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Skin and subcutaneous tissue disorders Hyperhidrosis	11.9% 38/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	7.9% 25/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Skin and subcutaneous tissue disorders Night sweats	7.5% 24/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	3.2% 10/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Skin and subcutaneous tissue disorders Pruritus	11.3% 36/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	9.1% 29/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Skin and subcutaneous tissue disorders Rash	19.8% 63/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	18.3% 58/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Vascular disorders Deep vein thrombosis	6.0% 19/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	3.2% 10/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Vascular disorders Flushing	5.0% 16/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	1.9% 6/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Vascular disorders Haematoma	5.3% 17/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	2.5% 8/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Vascular disorders Hypertension	12.6% 40/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	7.3% 23/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.
Vascular disorders Hypotension	10.4% 33/318 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.	3.8% 12/317 • From first dose up to 60 days post last dose of study therapy (Up to approximately 9 years) Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed/monitored for the treated population. All-Cause Mortality was assessed for the randomized population.

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Email: Clinical.Trials@bms.com

Results disclosure agreements

• Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
• Publication restrictions are in place

Restriction type: OTHER