Trial Outcomes & Findings for A Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Participants With Acute Coronary Syndrome (NCT NCT02293395)

NCT ID: NCT02293395

Last Updated: 2017-12-26

Results Overview

Non CABG-related TIMI clinically significant bleeding events are sum of non CABG-related TIMI major bleeding events, TIMI minor bleeding events and TIMI bleeding events requiring medical attention. Major: any symptomatic intracranial bleeding: clinically overt signs of hemorrhage with hemoglobin (Hb) drop of greater than or equal to (\>=)5 gram per deciliter (g/dl) (or absolute drop in hematocrit of \>=15%) and fatal bleeding (results in death within 7 days); Minor: clinically overt sign of hemorrhage with Hb drop of 3 - \<5 g/dl (or drop in hematocrit of 9 - \<15%); requiring medical attention: bleeding event that required medical, surgical treatment/laboratory evaluation and did not meet criteria for major/minor bleeding event.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 3037 participants
• Primary outcome timeframe: From start of study treatment until follow-up (up to 390 days)
• Results posted on: 2017-12-26

Participant Flow

A total of 3,145 participants were screened for eligibility, of these 108 participants were screening failures and the remaining 3,037 participants were randomized.

Participant milestones

Measure	Rivaroxaban 2.5 mg Twice Daily (BID) Participants received oral dose of 2.5 mg rivaroxaban BID and acetylsalicylic acid (ASA) placebo once daily (OD) along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.	Acetylsalicylic Acid 100 mg Once Daily (OD) Participants received oral dose of 100 mg ASA OD and rivaroxaban placebo BID along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.
Overall Study STARTED	1519	1518
Overall Study Treated	1510	1506
Overall Study COMPLETED	1510	1511
Overall Study NOT COMPLETED	9	7

Reasons for withdrawal

Measure	Rivaroxaban 2.5 mg Twice Daily (BID) Participants received oral dose of 2.5 mg rivaroxaban BID and acetylsalicylic acid (ASA) placebo once daily (OD) along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.	Acetylsalicylic Acid 100 mg Once Daily (OD) Participants received oral dose of 100 mg ASA OD and rivaroxaban placebo BID along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	8	7

Baseline Characteristics

A Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Participants With Acute Coronary Syndrome

Baseline characteristics by cohort

Measure	Rivaroxaban 2.5 mg Twice Daily (BID) n=1519 Participants Participants received oral dose of 2.5 mg rivaroxaban BID and acetylsalicylic acid (ASA) placebo once daily (OD) along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.	Acetylsalicylic Acid 100 mg Once Daily (OD) n=1518 Participants Participants received oral dose of 100 mg ASA OD and rivaroxaban placebo BID along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.	Total n=3037 Participants Total of all reporting groups
Age, Continuous	62.7 years STANDARD_DEVIATION 9.14 • n=5 Participants	62.9 years STANDARD_DEVIATION 8.82 • n=7 Participants	62.8 years STANDARD_DEVIATION 8.98 • n=5 Participants
Sex: Female, Male Female	385 Participants n=5 Participants	377 Participants n=7 Participants	762 Participants n=5 Participants
Sex: Female, Male Male	1134 Participants n=5 Participants	1141 Participants n=7 Participants	2275 Participants n=5 Participants
Race/Ethnicity, Customized White	1417 Participants n=5 Participants	1407 Participants n=7 Participants	2824 Participants n=5 Participants
Race/Ethnicity, Customized Black	24 Participants n=5 Participants	16 Participants n=7 Participants	40 Participants n=5 Participants
Race/Ethnicity, Customized Asian	54 Participants n=5 Participants	63 Participants n=7 Participants	117 Participants n=5 Participants
Race/Ethnicity, Customized Others	24 Participants n=5 Participants	32 Participants n=7 Participants	56 Participants n=5 Participants
Region of Enrollment ARGENTINA	66 participants n=5 Participants	65 participants n=7 Participants	131 participants n=5 Participants
Region of Enrollment AUSTRALIA	18 participants n=5 Participants	17 participants n=7 Participants	35 participants n=5 Participants
Region of Enrollment BELGIUM	49 participants n=5 Participants	40 participants n=7 Participants	89 participants n=5 Participants
Region of Enrollment BRAZIL	77 participants n=5 Participants	85 participants n=7 Participants	162 participants n=5 Participants
Region of Enrollment BULGARIA	83 participants n=5 Participants	78 participants n=7 Participants	161 participants n=5 Participants
Region of Enrollment CANADA	37 participants n=5 Participants	47 participants n=7 Participants	84 participants n=5 Participants
Region of Enrollment CZECH REPUBLIC	34 participants n=5 Participants	37 participants n=7 Participants	71 participants n=5 Participants
Region of Enrollment DENMARK	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment FRANCE	28 participants n=5 Participants	29 participants n=7 Participants	57 participants n=5 Participants
Region of Enrollment HUNGARY	101 participants n=5 Participants	100 participants n=7 Participants	201 participants n=5 Participants
Region of Enrollment ITALY	75 participants n=5 Participants	59 participants n=7 Participants	134 participants n=5 Participants
Region of Enrollment JAPAN	26 participants n=5 Participants	33 participants n=7 Participants	59 participants n=5 Participants
Region of Enrollment NETHERLANDS	69 participants n=5 Participants	65 participants n=7 Participants	134 participants n=5 Participants
Region of Enrollment POLAND	158 participants n=5 Participants	175 participants n=7 Participants	333 participants n=5 Participants
Region of Enrollment RUSSIA	237 participants n=5 Participants	244 participants n=7 Participants	481 participants n=5 Participants
Region of Enrollment SPAIN	62 participants n=5 Participants	60 participants n=7 Participants	122 participants n=5 Participants
Region of Enrollment SWEDEN	42 participants n=5 Participants	37 participants n=7 Participants	79 participants n=5 Participants
Region of Enrollment TURKEY	102 participants n=5 Participants	98 participants n=7 Participants	200 participants n=5 Participants
Region of Enrollment UKRAINE	137 participants n=5 Participants	129 participants n=7 Participants	266 participants n=5 Participants
Region of Enrollment UNITED STATES	93 participants n=5 Participants	88 participants n=7 Participants	181 participants n=5 Participants
Region of Enrollment Korea, Republic Of	24 participants n=5 Participants	30 participants n=7 Participants	54 participants n=5 Participants

PRIMARY outcome

Timeframe: From start of study treatment until follow-up (up to 390 days)

Population: Population analyzed included all randomized participants who had received at least one dose of study agent and had events that occurred between randomization and the last dose of the study agent plus 2 days or untreated participants who had events that occurred between randomization to 2 days thereafter.

Non CABG-related TIMI clinically significant bleeding events are sum of non CABG-related TIMI major bleeding events, TIMI minor bleeding events and TIMI bleeding events requiring medical attention. Major: any symptomatic intracranial bleeding: clinically overt signs of hemorrhage with hemoglobin (Hb) drop of greater than or equal to (>=)5 gram per deciliter (g/dl) (or absolute drop in hematocrit of >=15%) and fatal bleeding (results in death within 7 days); Minor: clinically overt sign of hemorrhage with Hb drop of 3 - <5 g/dl (or drop in hematocrit of 9 - <15%); requiring medical attention: bleeding event that required medical, surgical treatment/laboratory evaluation and did not meet criteria for major/minor bleeding event.

Outcome measures

Measure	Rivaroxaban 2.5 mg Twice Daily (BID) n=1519 Participants Participants received oral dose of 2.5 mg rivaroxaban BID and acetylsalicylic acid (ASA) placebo once daily (OD) along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.	Acetylsalicylic Acid 100 mg Once Daily (OD) n=1518 Participants Participants received oral dose of 100 mg ASA OD and rivaroxaban placebo BID along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.
Number of Participants With Non Coronary Artery Bypass Graft-Related (Non CABG-related) Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events	80 participants	74 participants

Adverse Events

Rivaroxaban 2.5 mg Twice Daily (BID)

Serious events: 125 serious events

Other events: 81 other events

Deaths: 0 deaths

Acetylsalicylic Acid 100 mg Once Daily (OD)

Serious events: 138 serious events

Other events: 84 other events

Deaths: 0 deaths

Serious adverse events

Measure	Rivaroxaban 2.5 mg Twice Daily (BID) n=1510 participants at risk Participants received oral dose of 2.5 mg rivaroxaban BID and acetylsalicylic acid (ASA) placebo once daily (OD) along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.	Acetylsalicylic Acid 100 mg Once Daily (OD) n=1506 participants at risk Participants received oral dose of 100 mg ASA OD and rivaroxaban placebo BID along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Musculoskeletal and connective tissue disorders Rapidly Progressive Osteoarthritis	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Blood and lymphatic system disorders Anaemia	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Cardiac disorders Acute Left Ventricular Failure	0.20% 3/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Cardiac disorders Acute Myocardial Infarction	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Cardiac disorders Angina Pectoris	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.13% 2/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Cardiac disorders Angina Unstable	0.33% 5/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.33% 5/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Cardiac disorders Aortic Valve Stenosis	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Cardiac disorders Atrial Fibrillation	0.20% 3/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.46% 7/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Cardiac disorders Atrial Flutter	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Cardiac disorders Atrioventricular Block Second Degree	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.13% 2/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Cardiac disorders Bradycardia	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Cardiac disorders Cardiac Failure	0.60% 9/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.46% 7/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Cardiac disorders Cardiac Failure Acute	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Cardiac disorders Cardiac Failure Chronic	0.20% 3/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Cardiac disorders Cardiac Failure Congestive	0.13% 2/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Cardiac disorders Cardiac Ventricular Thrombosis	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Cardiac disorders Cardiovascular Insufficiency	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Cardiac disorders Coronary Artery Disease	0.13% 2/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Cardiac disorders Coronary Artery Stenosis	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Cardiac disorders Intracardiac Thrombus	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Cardiac disorders Mitral Valve Incompetence	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Cardiac disorders Myocardial Fibrosis	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.13% 2/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Cardiac disorders Myocardial Ischaemia	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Cardiac disorders Myocardial Rupture	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Cardiac disorders Pericarditis	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Cardiac disorders Pleuropericarditis	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Cardiac disorders Postinfarction Angina	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Cardiac disorders Sinus Arrest	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Cardiac disorders Ventricular Extrasystoles	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Ear and labyrinth disorders Vertigo	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Ear and labyrinth disorders Vertigo Positional	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Eye disorders Cataract	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.13% 2/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Gastrointestinal disorders Abdominal Pain	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Gastrointestinal disorders Chronic Gastritis	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Gastrointestinal disorders Colitis Ulcerative	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Gastrointestinal disorders Diverticulum Intestinal	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Gastrointestinal disorders Erosive Oesophagitis	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Gastrointestinal disorders Gastritis	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Gastrointestinal disorders Gastroduodenitis	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Gastrointestinal disorders Intestinal Obstruction	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Gastrointestinal disorders Pancreatic Necrosis	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Gastrointestinal disorders Pancreatitis Acute	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.13% 2/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Gastrointestinal disorders Pancreatitis Chronic	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
General disorders Chest Pain	0.13% 2/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.13% 2/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
General disorders Death	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
General disorders Implant Site Ulcer	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
General disorders Multiple Organ Dysfunction Syndrome	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
General disorders Non-Cardiac Chest Pain	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
General disorders Stent-Graft Endoleak	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
General disorders Vascular Stent Restenosis	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
General disorders Vascular Stent Stenosis	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Hepatobiliary disorders Cholangitis	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Hepatobiliary disorders Cholecystitis	0.13% 2/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Hepatobiliary disorders Cholecystitis Acute	0.20% 3/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.33% 5/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Hepatobiliary disorders Cholelithiasis	0.20% 3/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Hepatobiliary disorders Drug-Induced Liver Injury	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Infections and infestations Appendicitis	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.13% 2/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Infections and infestations Bronchitis	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Infections and infestations Diverticulitis	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Infections and infestations Gangrene	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Infections and infestations Gastrointestinal Infection	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Infections and infestations H1n1 Influenza	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Infections and infestations Herpes Zoster	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Infections and infestations Infectious Pleural Effusion	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Infections and infestations Infective Exacerbation of Chronic Obstructive Airways Disease	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Infections and infestations Influenza	0.13% 2/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Infections and infestations Orchitis	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Infections and infestations Periodontitis	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Infections and infestations Pneumonia	0.46% 7/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.33% 5/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Infections and infestations Postoperative Wound Infection	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Infections and infestations Pyelonephritis Chronic	0.13% 2/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Infections and infestations Respiratory Tract Infection	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Infections and infestations Spinal Cord Infection	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Infections and infestations Urinary Tract Infection	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Injury, poisoning and procedural complications Alcohol Poisoning	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Injury, poisoning and procedural complications Concussion	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Injury, poisoning and procedural complications Coronary Artery Restenosis	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.20% 3/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Injury, poisoning and procedural complications Hand Fracture	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Injury, poisoning and procedural complications Heat Illness	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Injury, poisoning and procedural complications Hip Fracture	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Injury, poisoning and procedural complications Humerus Fracture	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Injury, poisoning and procedural complications Joint Dislocation	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Injury, poisoning and procedural complications Laceration	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Injury, poisoning and procedural complications Ligament Sprain	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Injury, poisoning and procedural complications Lower Limb Fracture	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.13% 2/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Injury, poisoning and procedural complications Lumbar Vertebral Fracture	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Injury, poisoning and procedural complications Radius Fracture	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Injury, poisoning and procedural complications Spinal Fracture	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Injury, poisoning and procedural complications Ulna Fracture	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Injury, poisoning and procedural complications Vascular Access Site Pain	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Injury, poisoning and procedural complications Vascular Graft Occlusion	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Injury, poisoning and procedural complications Vascular Pseudoaneurysm	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Investigations Cardiac Stress Test Abnormal	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.13% 2/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Investigations Haemoglobin Decreased	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Investigations Hepatic Enzyme Increased	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Investigations Liver Function Test Increased	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Investigations Mediastinoscopy	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Investigations Weight Decreased	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Metabolism and nutrition disorders Diabetes Mellitus	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.13% 2/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Musculoskeletal and connective tissue disorders Intervertebral Disc Disorder	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.13% 2/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Musculoskeletal and connective tissue disorders Ligamentitis	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Musculoskeletal and connective tissue disorders Musculoskeletal Discomfort	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Musculoskeletal and connective tissue disorders Rheumatoid Arthritis	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain Neoplasm	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix Carcinoma Recurrent	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer Recurrent	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric Cancer	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal Cancer	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal Carcinoma	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular Carcinoma	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Neoplasm Malignant	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Carcinoma	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.13% 2/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Adenocarcinoma	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Neoplasm	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary Gland Cancer Recurrent	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine Cancer	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine Leiomyoma	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vascular Neoplasm	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Nervous system disorders Carotid Artery Stenosis	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Nervous system disorders Facial Paralysis	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Nervous system disorders Intracranial Aneurysm	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Nervous system disorders Presyncope	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Nervous system disorders Seizure	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Nervous system disorders Syncope	0.13% 2/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.20% 3/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Nervous system disorders Vertebral Artery Stenosis	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Psychiatric disorders Alcohol Withdrawal Syndrome	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Psychiatric disorders Depression	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.13% 2/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Psychiatric disorders Panic Attack	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Renal and urinary disorders Acute Kidney Injury	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.13% 2/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Renal and urinary disorders Nephrolithiasis	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.13% 2/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Renal and urinary disorders Nephropathy Toxic	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Renal and urinary disorders Renal Artery Stenosis	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Renal and urinary disorders Renal Colic	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Renal and urinary disorders Ureterolithiasis	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Renal and urinary disorders Urinary Retention	0.13% 2/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Renal and urinary disorders Urinary Tract Obstruction	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Reproductive system and breast disorders Benign Prostatic Hyperplasia	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Respiratory, thoracic and mediastinal disorders Acute Pulmonary Oedema	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.13% 2/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Respiratory, thoracic and mediastinal disorders Asthma	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.20% 3/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Respiratory, thoracic and mediastinal disorders Cough	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.26% 4/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.27% 4/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.27% 4/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Respiratory, thoracic and mediastinal disorders Pulmonary Mass	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Respiratory, thoracic and mediastinal disorders Pulmonary Oedema	0.20% 3/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.20% 3/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Surgical and medical procedures Inguinal Hernia Repair	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Surgical and medical procedures Lung Neoplasm Surgery	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Surgical and medical procedures Lymphadenectomy	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Vascular disorders Aortic Aneurysm	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Vascular disorders Arteriosclerosis	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Vascular disorders Brachiocephalic Arteriosclerosis	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Vascular disorders Hypertension	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Vascular disorders Hypertensive Crisis	0.33% 5/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.13% 2/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Vascular disorders Hypotension	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Vascular disorders Peripheral Arterial Occlusive Disease	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Vascular disorders Peripheral Artery Aneurysm	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Vascular disorders Peripheral Artery Occlusion	0.00% 0/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Vascular disorders Peripheral Artery Stenosis	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.07% 1/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Vascular disorders Subclavian Artery Stenosis	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Vascular disorders Vascular Occlusion	0.07% 1/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.00% 0/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.

Other adverse events

Measure	Rivaroxaban 2.5 mg Twice Daily (BID) n=1510 participants at risk Participants received oral dose of 2.5 mg rivaroxaban BID and acetylsalicylic acid (ASA) placebo once daily (OD) along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.	Acetylsalicylic Acid 100 mg Once Daily (OD) n=1506 participants at risk Participants received oral dose of 100 mg ASA OD and rivaroxaban placebo BID along with either clopidogrel 75 mg OD or ticagrelor 90 mg BID for a minimum of 180 days, and up to 360 days of treatment.
General disorders Chest Pain	0.73% 11/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	1.3% 19/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Respiratory, thoracic and mediastinal disorders Cough	1.1% 16/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	0.93% 14/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.2% 33/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	2.6% 39/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.
Vascular disorders Hypertension	1.5% 23/1510 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.	1.5% 22/1506 • Up to 390 days Population analyzed included all randomized participants who had received at least one dose of study drug and had events between randomization and last dose of study drug +2 days. No comparison of adverse events between strata was planned.

Additional Information

Associate Director

Janssen Research & Development, LLC

Email: ClinicalTrialDisclosure@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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 in writing, such publication will be withheld for up to an additional 60 days.
• Publication restrictions are in place

Restriction type: OTHER