Trial Outcomes & Findings for A Study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus (NCT NCT01989754)

NCT ID: NCT01989754

Last Updated: 2018-12-11

Results Overview

Progression defined as the development of micro-albuminuria (Urine Albumin Creatinine Ratio \[UACR\] 30 to 300 milligram per gram \[mg/g\]) or macroalbuminuria (Albumin/creatinine ratio \[ACR\] of greater than \[\>\] 300 mg/g) in a participant with baseline normoalbuminuria (ACR less than \[\<\] 30 mg/g) or the development of macro-albuminuria in a participant with baseline microalbuminuria with an ACR increase greater than or equal to (\>=) 30 percent from baseline. Participants with macroalbuminuria at baseline (ACR\>300 mg/g) were excluded from the analysis. Event rate was estimated based on the time to the first occurrence of the event.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 5813 participants
• Primary outcome timeframe: Up to 3 years
• Results posted on: 2018-12-11

Participant Flow

A total of 5,813 participants were randomized. However, 1 participant was randomized twice and only the first randomization was included in the Intent-to-treat (ITT) analysis set. Thus 2,905 and 2,907 participants were randomly assigned to the placebo and canagliflozin groups in the ITT analysis set, respectively.

Participant milestones

Measure	Placebo (Placebo) Participants received one capsule of matching placebo orally once daily for the duration of the study or until early discontinuation from treatment.	Canagliflozin (Experimental) Participants received canagliflozin (JNJ-28431754) 100 milligram (mg) once daily during the first 13 weeks, then the dose was increased to 300 mg once daily (if the participant required additional glycemic control, provided the 100-mg dose was well tolerated).
Overall Study STARTED	2905	2907
Overall Study Treated	2903	2904
Overall Study COMPLETED	2866	2872
Overall Study NOT COMPLETED	39	35

Reasons for withdrawal

Measure	Placebo (Placebo) Participants received one capsule of matching placebo orally once daily for the duration of the study or until early discontinuation from treatment.	Canagliflozin (Experimental) Participants received canagliflozin (JNJ-28431754) 100 milligram (mg) once daily during the first 13 weeks, then the dose was increased to 300 mg once daily (if the participant required additional glycemic control, provided the 100-mg dose was well tolerated).
Overall Study Withdrawal by Subject	10	14
Overall Study Lost to Follow-up	28	20
Overall Study Closed Site	1	1

Baseline Characteristics

A Study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus

Baseline characteristics by cohort

Measure	Placebo (Placebo) n=2905 Participants Participants received one capsule of matching placebo orally once daily for the duration of the study or until early discontinuation from treatment.	Canagliflozin (Experimental) n=2907 Participants Participants received canagliflozin (JNJ-28431754) 100 milligram (mg) once daily during the first 13 weeks, then the dose was increased to 300 mg once daily (if the participant required additional glycemic control, provided the 100-mg dose was well tolerated).	Total n=5812 Participants Total of all reporting groups
Age, Continuous	64 years STANDARD_DEVIATION 8.28 • n=5 Participants	63.9 years STANDARD_DEVIATION 8.42 • n=7 Participants	64 years STANDARD_DEVIATION 8.35 • n=5 Participants
Sex: Female, Male Female	1111 Participants n=5 Participants	1053 Participants n=7 Participants	2164 Participants n=5 Participants
Sex: Female, Male Male	1794 Participants n=5 Participants	1854 Participants n=7 Participants	3648 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	586 Participants n=5 Participants	604 Participants n=7 Participants	1190 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2303 Participants n=5 Participants	2290 Participants n=7 Participants	4593 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	16 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	19 Participants n=5 Participants	14 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) Asian	245 Participants n=5 Participants	244 Participants n=7 Participants	489 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	09 Participants n=5 Participants	08 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) Black or African American	125 Participants n=5 Participants	106 Participants n=7 Participants	231 Participants n=5 Participants
Race (NIH/OMB) White	2372 Participants n=5 Participants	2393 Participants n=7 Participants	4765 Participants n=5 Participants
Race (NIH/OMB) More than one race	10 Participants n=5 Participants	09 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	125 Participants n=5 Participants	133 Participants n=7 Participants	258 Participants n=5 Participants
Race/Ethnicity, Customized Asian	245 Participants n=5 Participants	244 Participants n=7 Participants	489 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	125 Participants n=5 Participants	106 Participants n=7 Participants	231 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	407 Participants n=5 Participants	437 Participants n=7 Participants	844 Participants n=5 Participants
Race/Ethnicity, Customized Other	174 Participants n=5 Participants	172 Participants n=7 Participants	346 Participants n=5 Participants
Race/Ethnicity, Customized White Non-Hispanic	1954 Participants n=5 Participants	1948 Participants n=7 Participants	3902 Participants n=5 Participants
Region of Enrollment ARGENTINA	146 Participants n=5 Participants	159 Participants n=7 Participants	305 Participants n=5 Participants
Region of Enrollment AUSTRALIA	58 Participants n=5 Participants	51 Participants n=7 Participants	109 Participants n=5 Participants
Region of Enrollment BELGIUM	86 Participants n=5 Participants	66 Participants n=7 Participants	152 Participants n=5 Participants
Region of Enrollment BRAZIL	277 Participants n=5 Participants	272 Participants n=7 Participants	549 Participants n=5 Participants
Region of Enrollment CANADA	136 Participants n=5 Participants	146 Participants n=7 Participants	282 Participants n=5 Participants
Region of Enrollment CHINA	46 Participants n=5 Participants	46 Participants n=7 Participants	92 Participants n=5 Participants
Region of Enrollment CZECH REPUBLIC	67 Participants n=5 Participants	72 Participants n=7 Participants	139 Participants n=5 Participants
Region of Enrollment FRANCE	69 Participants n=5 Participants	55 Participants n=7 Participants	124 Participants n=5 Participants
Region of Enrollment GERMANY	46 Participants n=5 Participants	55 Participants n=7 Participants	101 Participants n=5 Participants
Region of Enrollment HUNGARY	82 Participants n=5 Participants	97 Participants n=7 Participants	179 Participants n=5 Participants
Region of Enrollment ITALY	49 Participants n=5 Participants	49 Participants n=7 Participants	98 Participants n=5 Participants
Region of Enrollment MALAYSIA	50 Participants n=5 Participants	42 Participants n=7 Participants	92 Participants n=5 Participants
Region of Enrollment MEXICO	118 Participants n=5 Participants	110 Participants n=7 Participants	228 Participants n=5 Participants
Region of Enrollment NETHERLANDS	117 Participants n=5 Participants	132 Participants n=7 Participants	249 Participants n=5 Participants
Region of Enrollment NEW ZEALAND	49 Participants n=5 Participants	56 Participants n=7 Participants	105 Participants n=5 Participants
Region of Enrollment POLAND	186 Participants n=5 Participants	177 Participants n=7 Participants	363 Participants n=5 Participants
Region of Enrollment RUSSIAN FEDERATION	213 Participants n=5 Participants	199 Participants n=7 Participants	412 Participants n=5 Participants
Region of Enrollment SOUTH KOREA	73 Participants n=5 Participants	94 Participants n=7 Participants	167 Participants n=5 Participants
Region of Enrollment SPAIN	247 Participants n=5 Participants	249 Participants n=7 Participants	496 Participants n=5 Participants
Region of Enrollment SWEDEN	118 Participants n=5 Participants	103 Participants n=7 Participants	221 Participants n=5 Participants
Region of Enrollment TAIWAN	44 Participants n=5 Participants	32 Participants n=7 Participants	76 Participants n=5 Participants
Region of Enrollment UKRAINE	213 Participants n=5 Participants	236 Participants n=7 Participants	449 Participants n=5 Participants
Region of Enrollment UNITED KINGDOM	78 Participants n=5 Participants	73 Participants n=7 Participants	151 Participants n=5 Participants
Region of Enrollment UNITED STATES	337 Participants n=5 Participants	336 Participants n=7 Participants	673 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 3 years

Population: The intent to treat (ITT) population included all participants who were randomized. Here 'N' signifies number of participants who were evaluable for this endpoint.

Progression defined as the development of micro-albuminuria (Urine Albumin Creatinine Ratio [UACR] 30 to 300 milligram per gram [mg/g]) or macroalbuminuria (Albumin/creatinine ratio [ACR] of greater than [>] 300 mg/g) in a participant with baseline normoalbuminuria (ACR less than [<] 30 mg/g) or the development of macro-albuminuria in a participant with baseline microalbuminuria with an ACR increase greater than or equal to (>=) 30 percent from baseline. Participants with macroalbuminuria at baseline (ACR>300 mg/g) were excluded from the analysis. Event rate was estimated based on the time to the first occurrence of the event.

Outcome measures

Measure	Placebo n=2905 Participants Participants received one capsule of matching placebo orally once daily for the duration of the study or until early discontinuation from treatment.	Canagliflozin (Experimental) n=2907 Participants Participants received canagliflozin (JNJ-28431754) 100 milligram (mg) once daily during the first 13 weeks, then the dose was increased to 300 mg once daily (if the participant required additional glycemic control, provided the 100-mg dose was well tolerated).
Progression of Albuminuria	153.01 Events per 1000 patient-year	99.80 Events per 1000 patient-year

SECONDARY outcome

Timeframe: Approximately 3 years

Population: ITT population included all participants who were randomized.

Analyses were using adjudicated events, that is (i.e.) CV death events or hospitalization due to heart failure, and adjudication of these outcomes by the Endpoint Adjudication Committee (EAC) were done in a blinded fashion. Event rate was estimated based on the time to the first occurrence of the event.

Outcome measures

Measure	Placebo n=2905 Participants Participants received one capsule of matching placebo orally once daily for the duration of the study or until early discontinuation from treatment.	Canagliflozin (Experimental) n=2907 Participants Participants received canagliflozin (JNJ-28431754) 100 milligram (mg) once daily during the first 13 weeks, then the dose was increased to 300 mg once daily (if the participant required additional glycemic control, provided the 100-mg dose was well tolerated).
Composite of Cardiovascular (CV) Death Events or Hospitalization for Heart Failure	21.91 Events per 1000 patient-years	15.85 Events per 1000 patient-years

SECONDARY outcome

Timeframe: Approximately 3 years

Population: ITT population included all participants who were randomized.

Analyses were using adjudicated events, i.e. CV death events, and adjudication of these outcomes by the Endpoint Adjudication Committee (EAC) were done in a blinded fashion. Event rate was estimated based on the time to the first occurrence of the event.

Outcome measures

Measure	Placebo n=2905 Participants Participants received one capsule of matching placebo orally once daily for the duration of the study or until early discontinuation from treatment.	Canagliflozin (Experimental) n=2907 Participants Participants received canagliflozin (JNJ-28431754) 100 milligram (mg) once daily during the first 13 weeks, then the dose was increased to 300 mg once daily (if the participant required additional glycemic control, provided the 100-mg dose was well tolerated).
Cardiovascular (CV) Death	11.60 Events per 1000 patient-years	10.06 Events per 1000 patient-years

Adverse Events

Placebo (Placebo)

Serious events: 775 serious events

Other events: 25 other events

Deaths: 71 deaths

Canagliflozin (Experimental)

Serious events: 714 serious events

Other events: 94 other events

Deaths: 68 deaths

Serious adverse events

Measure	Placebo (Placebo) n=2903 participants at risk Participants received one capsule of matching placebo orally once daily for the duration of the study or until early discontinuation from treatment.	Canagliflozin (Experimental) n=2904 participants at risk Participants received canagliflozin (JNJ-28431754) 100 milligram (mg) once daily during the first 13 weeks, then the dose was increased to 300 mg once daily (if the participant required additional glycemic control, provided the 100-mg dose was well tolerated).
Skin and subcutaneous tissue disorders Urticaria	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Post Procedural Haematuria	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Post Procedural Haemorrhage	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Postoperative Hernia	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Social circumstances Penile Prosthesis User	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Social circumstances Victim of Homicide	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Surgical and medical procedures Coronary Arterial Stent Insertion	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Postoperative Respiratory Failure	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Surgical and medical procedures Hospitalisation	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Surgical and medical procedures Stent Placement	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Vascular disorders Aortic Aneurysm	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Vascular disorders Aortic Arteriosclerosis	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Blood and lymphatic system disorders Anaemia	0.21% 6/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.34% 10/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Blood and lymphatic system disorders Febrile Neutropenia	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Blood and lymphatic system disorders Iron Deficiency Anaemia	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Blood and lymphatic system disorders Polycythaemia	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Blood and lymphatic system disorders Thrombocytopenia	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Acute Coronary Syndrome	0.38% 11/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.14% 4/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Acute Left Ventricular Failure	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Acute Myocardial Infarction	0.90% 26/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	1.1% 32/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Adams-Stokes Syndrome	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Angina Pectoris	1.1% 33/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.76% 22/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Angina Unstable	1.4% 42/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	1.4% 42/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Aortic Valve Disease	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Aortic Valve Incompetence	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Arrhythmia	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Arteriosclerosis Coronary Artery	0.17% 5/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.10% 3/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Atrial Fibrillation	0.62% 18/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.48% 14/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Atrial Flutter	0.24% 7/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.17% 5/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Atrial Tachycardia	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Atrioventricular Block Complete	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.10% 3/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Atrioventricular Block Second Degree	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Bradycardia	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Cardiac Arrest	0.31% 9/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.17% 5/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Cardiac Disorder	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Cardiac Failure	1.4% 41/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.65% 19/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Cardiac Failure Acute	0.10% 3/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Cardiac Failure Chronic	0.10% 3/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.14% 4/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Cardiac Failure Congestive	0.62% 18/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.38% 11/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Cardiac Valve Disease	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Cardio-Respiratory Arrest	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Cardiogenic Shock	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Cardiopulmonary Failure	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Conduction Disorder	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Congestive Cardiomyopathy	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Coronary Artery Disease	1.00% 29/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	1.2% 34/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Coronary Artery Insufficiency	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Coronary Artery Occlusion	0.10% 3/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.14% 4/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Coronary Artery Stenosis	0.28% 8/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.17% 5/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Diabetic Cardiomyopathy	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Ischaemic Cardiomyopathy	0.14% 4/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Left Ventricular Dysfunction	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Left Ventricular Failure	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Mitral Valve Stenosis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Myocardial Fibrosis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Myocardial Infarction	0.83% 24/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	1.1% 31/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Myocardial Ischaemia	0.31% 9/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.24% 7/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Pericardial Effusion	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Pericarditis	0.10% 3/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Prinzmetal Angina	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Right Ventricular Failure	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Sinus Bradycardia	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Sinus Node Dysfunction	0.14% 4/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Supraventricular Tachycardia	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Tachycardia	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Tricuspid Valve Incompetence	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Ventricular Arrhythmia	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Ventricular Asystole	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Ventricular Extrasystoles	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Ventricular Fibrillation	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Cardiac disorders Ventricular Tachycardia	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Ear and labyrinth disorders Haematotympanum	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Ear and labyrinth disorders Hypoacusis	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Ear and labyrinth disorders Vertigo	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Endocrine disorders Basedow's Disease	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Endocrine disorders Hyperparathyroidism	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Endocrine disorders Hyperparathyroidism Primary	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Endocrine disorders Hyperthyroidism	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Eye disorders Amaurosis Fugax	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Eye disorders Cataract	0.10% 3/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.34% 10/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Eye disorders Diabetic Retinopathy	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Eye disorders Diplopia	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Eye disorders Eye Haemorrhage	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Eye disorders Eye Pain	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Eye disorders Eyelid Ptosis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Eye disorders Glaucoma	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Eye disorders Macular Fibrosis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Eye disorders Retinal Artery Occlusion	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Eye disorders Retinal Detachment	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Eye disorders Retinopathy	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Abdominal Hernia	0.10% 3/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Abdominal Pain	0.17% 5/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Abdominal Pain Lower	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Abdominal Pain Upper	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Anal Fistula	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Ascites	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Barrett's Oesophagus	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Bowel Movement Irregularity	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Colitis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Colitis Ischaemic	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Colitis Microscopic	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Colitis Ulcerative	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Colonic Pseudo-Obstruction	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Constipation	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Diarrhoea	0.14% 4/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Diverticular Perforation	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Diverticulum	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Diverticulum Intestinal	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Duodenal Ulcer	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Duodenal Ulcer Haemorrhage	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Duodenal Ulcer Perforation	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Enterocolitis	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Food Poisoning	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Gastric Polyps	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Gastroduodenitis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Gastrointestinal Haemorrhage	0.10% 3/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.10% 3/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Haematemesis	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Ileus	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Impaired Gastric Emptying	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Inguinal Hernia	0.14% 4/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Intestinal Haemorrhage	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Intestinal Ischaemia	0.10% 3/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Intestinal Obstruction	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Intestinal Ulcer Perforation	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Large Intestine Perforation	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Lower Gastrointestinal Haemorrhage	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Melaena	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Mesenteric Arterial Occlusion	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Mesenteric Vein Thrombosis	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Oesophageal Obstruction	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Pancreatitis	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Pancreatitis Acute	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.10% 3/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Peptic Ulcer	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Pneumoperitoneum	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Rectal Tenesmus	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Salivary Gland Calculus	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Salivary Gland Fistula	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Small Intestinal Obstruction	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Swollen Tongue	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Tooth Disorder	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Umbilical Hernia	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.21% 6/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Upper Gastrointestinal Haemorrhage	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.10% 3/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Gastrointestinal disorders Volvulus	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
General disorders Adverse Drug Reaction	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
General disorders Cardiac Death	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
General disorders Chest Discomfort	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
General disorders Chest Pain	0.59% 17/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.76% 22/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
General disorders Complication Associated with Device	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
General disorders Cyst	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
General disorders Death	0.24% 7/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.17% 5/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
General disorders Drug Intolerance	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
General disorders Gait Disturbance	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
General disorders Generalised Oedema	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
General disorders Impaired Healing	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
General disorders Malaise	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
General disorders Non-Cardiac Chest Pain	0.24% 7/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.31% 9/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
General disorders Oedema Peripheral	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
General disorders Peripheral Swelling	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
General disorders Pyrexia	0.10% 3/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
General disorders Sudden Cardiac Death	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
General disorders Sudden Death	0.21% 6/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.21% 6/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
General disorders Vascular Stent Restenosis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
General disorders Vascular Stent Thrombosis	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Hepatobiliary disorders Bile Duct Stone	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Hepatobiliary disorders Biliary Colic	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Hepatobiliary disorders Cholangitis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Hepatobiliary disorders Cholangitis Acute	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Hepatobiliary disorders Cholecystitis	0.10% 3/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.10% 3/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Hepatobiliary disorders Cholecystitis Acute	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Hepatobiliary disorders Cholelithiasis	0.24% 7/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.17% 5/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Hepatobiliary disorders Cholelithiasis Obstructive	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Hepatobiliary disorders Gallbladder Polyp	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Hepatobiliary disorders Haemobilia	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Hepatobiliary disorders Hepatic Cirrhosis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Hepatobiliary disorders Hepatic Lesion	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Hepatobiliary disorders Hydrocholecystis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Hepatobiliary disorders Jaundice Cholestatic	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Hepatobiliary disorders Liver Injury	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Hepatobiliary disorders Non-Alcoholic Steatohepatitis	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Immune system disorders Anaphylactic Reaction	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Immune system disorders Drug Hypersensitivity	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Immune system disorders Sarcoidosis	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Abscess	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Abscess Limb	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Abscess Neck	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Appendicitis	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.21% 6/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Arthritis Bacterial	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Bronchitis	0.10% 3/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Campylobacter Gastroenteritis	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Carbuncle	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Cellulitis	0.38% 11/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.31% 9/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Cellulitis Staphylococcal	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Cellulitis Streptococcal	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Cholecystitis Infective	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Colonic Abscess	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Device Related Infection	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Diabetic Foot Infection	0.14% 4/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.10% 3/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Diabetic Gangrene	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Diverticulitis	0.10% 3/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.10% 3/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Ear Infection	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Empyema	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Endocarditis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Epididymitis	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Erysipelas	0.17% 5/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Escherichia Infection	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Escherichia Sepsis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Escherichia Urinary Tract Infection	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Eye Infection	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Gangrene	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.17% 5/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Gastroenteritis	0.31% 9/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.28% 8/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Gastroenteritis Viral	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Genital Infection Fungal	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Hepatitis B	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Herpes Zoster	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Hiv Infection	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Infected Dermal Cyst	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Infected Skin Ulcer	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.10% 3/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Infection	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Infective Exacerbation of Chronic Obstructive Airways Disease	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Influenza	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.17% 5/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Intervertebral Discitis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Laryngitis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Localised Infection	0.21% 6/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.17% 5/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Lower Respiratory Tract Infection	0.21% 6/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Lung Abscess	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Mastoiditis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Orchitis	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Osteomyelitis	0.17% 5/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.21% 6/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Osteomyelitis Chronic	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Otitis Media Acute	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Parasitic Gastroenteritis	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Paronychia	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Pelvic Abscess	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Penile Abscess	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Perinephric Abscess	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Peritonsillar Abscess	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Pharyngotonsillitis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Pneumococcal Sepsis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Pneumonia	1.1% 31/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.90% 26/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Pneumonia Legionella	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Pneumonia Pneumococcal	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Post Procedural Infection	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Post Procedural Sepsis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Postoperative Wound Infection	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Pulmonary Sepsis	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Pulmonary Tuberculosis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Pyelonephritis	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.17% 5/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Pyelonephritis Acute	0.10% 3/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Respiratory Tract Infection	0.45% 13/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.17% 5/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Scrotal Abscess	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Scrotal Infection	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Sepsis	0.31% 9/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.14% 4/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Septic Shock	0.21% 6/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.14% 4/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Sinusitis	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Soft Tissue Infection	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Staphylococcal Infection	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Staphylococcal Sepsis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Stenotrophomonas Infection	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Subcutaneous Abscess	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Tooth Abscess	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Tooth Infection	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Tracheobronchitis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Upper Respiratory Tract Infection	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Urinary Tract Infection	0.45% 13/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.38% 11/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Urinary Tract Infection Enterococcal	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Urosepsis	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Infections and infestations Wound Infection	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Ankle Fracture	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Arterial Bypass Stenosis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Carotid Artery Restenosis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Cataract Operation Complication	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Clavicle Fracture	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Concussion	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Contusion	0.10% 3/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Craniocerebral Injury	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Epiphyseal Fracture	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Eye Injury	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Facial Bones Fracture	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.10% 3/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Fall	0.14% 4/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.17% 5/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Femoral Neck Fracture	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Femur Fracture	0.21% 6/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.14% 4/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Fibula Fracture	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Foot Fracture	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Fractured Coccyx	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Hand Fracture	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Head Injury	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Hip Fracture	0.17% 5/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.10% 3/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Humerus Fracture	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.10% 3/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Jaw Fracture	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Joint Dislocation	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Laceration	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Ligament Sprain	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Limb Crushing Injury	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Limb Injury	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.17% 5/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Lumbar Vertebral Fracture	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Meniscus Injury	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Patella Fracture	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Pneumocephalus	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Post Laminectomy Syndrome	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Post Procedural Haematoma	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Procedural Headache	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Procedural Pain	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Pubis Fracture	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Radius Fracture	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Rib Fracture	0.14% 4/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.14% 4/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Road Traffic Accident	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Spinal Fracture	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Subarachnoid Haemorrhage	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Subdural Haematoma	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Suture Related Complication	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Tendon Injury	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Tendon Rupture	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Thermal Burn	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Thoracic Vertebral Fracture	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Tibia Fracture	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.14% 4/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Toxicity to Various Agents	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Traumatic Fracture	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Traumatic Ulcer	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Ulna Fracture	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Upper Limb Fracture	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Vascular Graft Stenosis	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Wound	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Wound Dehiscence	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Wound Necrosis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Injury, poisoning and procedural complications Wrist Fracture	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Investigations Arteriogram Coronary	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Investigations Blood Creatinine Increased	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Investigations Blood Glucose Increased	0.10% 3/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Investigations Ejection Fraction Decreased	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Investigations Electrocardiogram QT Prolonged	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Investigations Electrocardiogram St-T Change	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Investigations Electrocardiogram T Wave Inversion	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Investigations International Normalised Ratio Increased	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Investigations Liver Function Test Increased	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Investigations Platelet Count Decreased	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Investigations White Blood Cell Count Decreased	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Metabolism and nutrition disorders Acidosis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Metabolism and nutrition disorders Cachexia	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Metabolism and nutrition disorders Dehydration	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.10% 3/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Metabolism and nutrition disorders Diabetes Mellitus	0.62% 18/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.17% 5/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Metabolism and nutrition disorders Diabetes Mellitus Inadequate Control	0.41% 12/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.21% 6/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Metabolism and nutrition disorders Diabetic Complication	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Metabolism and nutrition disorders Diabetic Ketoacidosis	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.17% 5/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Metabolism and nutrition disorders Electrolyte Imbalance	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Metabolism and nutrition disorders Fluid Overload	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Metabolism and nutrition disorders Gout	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Metabolism and nutrition disorders Hyperglycaemia	0.38% 11/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.17% 5/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Metabolism and nutrition disorders Hyperkalaemia	0.17% 5/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Metabolism and nutrition disorders Hyperosmolar Hyperglycaemic State	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Metabolism and nutrition disorders Hypoglycaemia	0.31% 9/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.21% 6/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Metabolism and nutrition disorders Hypokalaemia	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Metabolism and nutrition disorders Hyponatraemia	0.14% 4/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.10% 3/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Metabolism and nutrition disorders Hypovolaemia	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Metabolism and nutrition disorders Lactic Acidosis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Metabolism and nutrition disorders Metabolic Acidosis	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Metabolism and nutrition disorders Obesity	0.10% 3/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Metabolism and nutrition disorders Type 2 Diabetes Mellitus	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.10% 3/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.14% 4/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Musculoskeletal and connective tissue disorders Arthritis	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Musculoskeletal and connective tissue disorders Arthropathy	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Musculoskeletal and connective tissue disorders Back Pain	0.38% 11/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Musculoskeletal and connective tissue disorders Bursitis	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Musculoskeletal and connective tissue disorders Cervical Spinal Stenosis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Musculoskeletal and connective tissue disorders Costochondritis	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Musculoskeletal and connective tissue disorders Dactylitis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Musculoskeletal and connective tissue disorders Dupuytren's Contracture	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Musculoskeletal and connective tissue disorders Extremity Contracture	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Musculoskeletal and connective tissue disorders Foot Deformity	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Musculoskeletal and connective tissue disorders Intervertebral Disc Compression	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Musculoskeletal and connective tissue disorders Intervertebral Disc Disorder	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	0.17% 5/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.24% 7/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Musculoskeletal and connective tissue disorders Knee Deformity	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Musculoskeletal and connective tissue disorders Lumbar Spinal Stenosis	0.14% 4/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Musculoskeletal and connective tissue disorders Muscular Weakness	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Musculoskeletal and connective tissue disorders Osteitis	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.55% 16/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.45% 13/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Musculoskeletal and connective tissue disorders Pathological Fracture	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Musculoskeletal and connective tissue disorders Plantar Fasciitis	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Musculoskeletal and connective tissue disorders Polymyalgia Rheumatica	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Musculoskeletal and connective tissue disorders Rotator Cuff Syndrome	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.14% 4/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Musculoskeletal and connective tissue disorders Sacroiliitis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Musculoskeletal and connective tissue disorders Spinal Column Stenosis	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Musculoskeletal and connective tissue disorders Spinal Osteoarthritis	0.14% 4/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Musculoskeletal and connective tissue disorders Spinal Pain	0.10% 3/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.10% 3/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Musculoskeletal and connective tissue disorders Synovial Cyst	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Musculoskeletal and connective tissue disorders Tendonitis	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Musculoskeletal and connective tissue disorders Tenosynovitis Stenosans	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Musculoskeletal and connective tissue disorders Trigger Finger	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute Myeloid Leukaemia	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma Gastric	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of Colon	0.10% 3/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenosquamous Cell Lung Cancer	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-Cell Lymphoma	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Lung Neoplasm	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Neoplasm	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Neoplasm of Thyroid Gland	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile Duct Cancer	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Cancer	0.14% 4/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.14% 4/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Cancer Recurrent	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Transitional Cell Carcinoma	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's Disease	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Adenoma	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.10% 3/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer Metastatic	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer Stage Ii	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer Stage Iii	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cerebral Hygroma	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic Myeloid Leukaemia	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Adenoma	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.14% 4/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer Metastatic	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal Adenocarcinoma	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal Cancer	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse Large B-Cell Lymphoma	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric Cancer	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's Disease	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive Ductal Breast Carcinoma	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large Cell Lung Cancer	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal Cancer	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Adenocarcinoma	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.14% 4/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Adenocarcinoma Metastatic	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Cancer Metastatic	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Neoplasm Malignant	0.21% 6/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.21% 6/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.10% 3/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma in Situ	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Neoplasm of Unknown Primary Site	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mediastinum Neoplasm	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma Benign	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to Central Nervous System	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to Liver	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine Carcinoma Metastatic	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine Tumour	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's Lymphoma	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Small Cell Lung Cancer	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal Squamous Cell Carcinoma	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian Cancer Metastatic	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Carcinoma	0.21% 6/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary Cystadenoma Lymphomatosum	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary Thyroid Cancer	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma Cell Myeloma	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.28% 8/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer Metastatic	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Cancer	0.10% 3/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cancer	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Schwannoma	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Serous Cystadenocarcinoma of Pancreas	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small Cell Lung Cancer Metastatic	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma of Lung	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma of Skin	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma of the Oral Cavity	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma of the Tongue	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue Neoplasm Malignant Stage Unspecified	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ureteric Cancer	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine Cancer	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine Leiomyoma	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Basilar Artery Occlusion	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Brain Injury	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Brain Stem Infarction	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Brain Stem Stroke	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Carotid Arteriosclerosis	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Carotid Artery Occlusion	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Carotid Artery Stenosis	0.24% 7/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.31% 9/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Carpal Tunnel Syndrome	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Cerebellar Infarction	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Cerebral Haematoma	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Cerebral Haemorrhage	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.10% 3/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Cerebral Infarction	0.17% 5/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.14% 4/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Cerebral Ischaemia	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Cerebrovascular Accident	1.3% 37/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.52% 15/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Cervicobrachial Syndrome	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Cognitive Disorder	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Diabetic Mononeuropathy	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Diabetic Neuropathy	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Dizziness Postural	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Embolic Stroke	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Epilepsy	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Facial Nerve Disorder	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Generalised Tonic-Clonic Seizure	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Haemorrhagic Stroke	0.14% 4/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Headache	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Hemiparesis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Hydrocephalus	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Hypertensive Encephalopathy	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Hypoxic-Ischaemic Encephalopathy	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Intraventricular Haemorrhage	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Ischaemic Cerebral Infarction	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Ischaemic Stroke	0.41% 12/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.69% 20/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Lacunar Infarction	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Lacunar Stroke	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Lethargy	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Loss of Consciousness	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Lumbar Radiculopathy	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Metabolic Encephalopathy	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Migraine	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Myasthenia Gravis	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Myasthenia Gravis Crisis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Nerve Compression	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Neuralgia	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Paraesthesia	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Peripheral Nerve Paresis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Presyncope	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.10% 3/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Radiculopathy	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Sciatica	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Seizure	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Sensory Loss	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Spinal Cord Compression	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Syncope	0.28% 8/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.34% 10/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Thalamic Infarction	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Toxic Encephalopathy	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Transient Ischaemic Attack	0.34% 10/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.28% 8/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Tremor	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Trigeminal Neuralgia	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Vascular Encephalopathy	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Vascular Headache	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Vertebral Artery Occlusion	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Vertebrobasilar Insufficiency	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Nervous system disorders Vocal Cord Paralysis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Product Issues Device Breakage	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Product Issues Device Loosening	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Product Issues Device Malfunction	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Product Issues Patient-Device Incompatibility	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Psychiatric disorders Bipolar Disorder	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Psychiatric disorders Completed Suicide	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Psychiatric disorders Confusional State	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Psychiatric disorders Delirium	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Psychiatric disorders Depression	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Psychiatric disorders Depression Suicidal	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Psychiatric disorders Emotional Disorder	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Psychiatric disorders Major Depression	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Psychiatric disorders Psychotic Disorder	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Psychiatric disorders Suicidal Ideation	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Psychiatric disorders Suicide Attempt	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Renal and urinary disorders Acute Kidney Injury	0.52% 15/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.24% 7/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Renal and urinary disorders Bladder Obstruction	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Renal and urinary disorders Chronic Kidney Disease	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.10% 3/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Renal and urinary disorders Diabetic Nephropathy	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Renal and urinary disorders Haematuria	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.10% 3/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Renal and urinary disorders Hydronephrosis	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Renal and urinary disorders Ketonuria	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Renal and urinary disorders Nephrolithiasis	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.28% 8/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Renal and urinary disorders Nephropathy	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Renal and urinary disorders Nephropathy Toxic	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Renal and urinary disorders Nephrotic Syndrome	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Renal and urinary disorders Pelvi-Ureteric Obstruction	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Renal and urinary disorders Pollakiuria	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Renal and urinary disorders Proteinuria	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Renal and urinary disorders Renal Colic	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Renal and urinary disorders Renal Failure	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Renal and urinary disorders Renal Haematoma	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Renal and urinary disorders Renal Impairment	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Renal and urinary disorders Renal Injury	0.10% 3/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Renal and urinary disorders Stress Urinary Incontinence	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Renal and urinary disorders Tubulointerstitial Nephritis	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Renal and urinary disorders Ureterolithiasis	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Renal and urinary disorders Urethral Stenosis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Renal and urinary disorders Urinary Incontinence	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Renal and urinary disorders Urinary Retention	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Reproductive system and breast disorders Balanoposthitis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Reproductive system and breast disorders Benign Prostatic Hyperplasia	0.17% 5/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.14% 4/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Reproductive system and breast disorders Endometrial Hyperplasia	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Reproductive system and breast disorders Endometrial Hypertrophy	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Reproductive system and breast disorders Epididymal Disorder	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Reproductive system and breast disorders Erectile Dysfunction	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Reproductive system and breast disorders Fallopian Tube Cyst	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Reproductive system and breast disorders Peyronie's Disease	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Reproductive system and breast disorders Prostatitis	0.10% 3/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Reproductive system and breast disorders Prostatomegaly	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Reproductive system and breast disorders Uterine Polyp	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Reproductive system and breast disorders Uterine Prolapse	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Acute Pulmonary Oedema	0.17% 5/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Distress Syndrome	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.10% 3/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Asthma	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.10% 3/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Asthmatic Crisis	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Bronchitis Chronic	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.38% 11/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Cough	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.28% 8/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.28% 8/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.10% 3/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Hypoventilation	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Mediastinal Effusion	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Nasal Obstruction	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.17% 5/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Pneumonia Aspiration	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.17% 5/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.21% 6/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary Fibrosis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary Mass	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary Oedema	0.21% 6/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary Sarcoidosis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Respiratory Acidosis	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Respiratory Alkalosis	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.10% 3/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Sleep Apnoea Syndrome	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Respiratory, thoracic and mediastinal disorders Vocal Cord Leukoplakia	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Skin and subcutaneous tissue disorders Angioedema	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Skin and subcutaneous tissue disorders Dermatitis Allergic	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Skin and subcutaneous tissue disorders Diabetic Foot	0.31% 9/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.34% 10/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Skin and subcutaneous tissue disorders Diabetic Ulcer	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Skin and subcutaneous tissue disorders Skin Fissures	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Skin and subcutaneous tissue disorders Skin Necrosis	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Skin and subcutaneous tissue disorders Skin Ulcer	0.17% 5/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.24% 7/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Vascular disorders Aortic Stenosis	0.14% 4/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.17% 5/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Vascular disorders Arterial Thrombosis	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Vascular disorders Arteriosclerosis	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.07% 2/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Vascular disorders Circulatory Collapse	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Vascular disorders Deep Vein Thrombosis	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Vascular disorders Diabetic Vascular Disorder	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Vascular disorders Extremity Necrosis	0.17% 5/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.10% 3/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Vascular disorders Haematoma	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Vascular disorders Hypertension	0.14% 4/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Vascular disorders Hypertensive Crisis	0.21% 6/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Vascular disorders Hypotension	0.10% 3/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Vascular disorders Hypovolaemic Shock	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Vascular disorders Iliac Artery Occlusion	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Vascular disorders Intermittent Claudication	0.10% 3/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.14% 4/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Vascular disorders Orthostatic Hypotension	0.14% 4/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Vascular disorders Peripheral Arterial Occlusive Disease	0.31% 9/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.31% 9/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Vascular disorders Peripheral Artery Occlusion	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.14% 4/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Vascular disorders Peripheral Artery Stenosis	0.07% 2/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.28% 8/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Vascular disorders Peripheral Artery Thrombosis	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.00% 0/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Vascular disorders Peripheral Embolism	0.03% 1/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Vascular disorders Peripheral Ischaemia	0.17% 5/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.24% 7/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Vascular disorders Peripheral Vascular Disorder	0.14% 4/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.31% 9/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Vascular disorders Peripheral Venous Disease	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Vascular disorders Poor Peripheral Circulation	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Vascular disorders Post Thrombotic Syndrome	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.
Vascular disorders Vascular Insufficiency	0.00% 0/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	0.03% 1/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.

Other adverse events

Measure	Placebo (Placebo) n=2903 participants at risk Participants received one capsule of matching placebo orally once daily for the duration of the study or until early discontinuation from treatment.	Canagliflozin (Experimental) n=2904 participants at risk Participants received canagliflozin (JNJ-28431754) 100 milligram (mg) once daily during the first 13 weeks, then the dose was increased to 300 mg once daily (if the participant required additional glycemic control, provided the 100-mg dose was well tolerated).
Reproductive system and breast disorders Balanoposthitis	0.86% 25/2903 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.	3.2% 94/2904 • Approximately 3 years On-treatment analysis set included all randomized participants who were treated and received at least 1 dose of study drug. The number of deaths (all causes) reported here is adjudicated death that occurred within 30 days of the last dose of the study drug.

Additional Information

Director Clinical Development

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: ClinicalTrialDisclosure@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
• Publication restrictions are in place

Restriction type: OTHER