Trial Outcomes & Findings for A Study of Rivaroxaban (JNJ-39039039) on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients (NCT NCT02111564)

NCT ID: NCT02111564

Last Updated: 2019-11-25

Results Overview

Symptomatic VTE included lower extremity deep vein thrombosis (DVT) and non-fatal pulmonary embolism (PE). Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 12024 participants
• Primary outcome timeframe: Up to Day 45
• Results posted on: 2019-11-25

Participant Flow

12024 participants were randomized (rivaroxaban-6007;placebo-6017). 5 participants in placebo were excluded(2 invalid consent,3 randomized before Health Authority approval).

Participants were randomized (1:1) to receive rivaroxaban or placebo. In rivaroxaban, participants were treated with rivaroxaban 10 mg or 7.5 mg as per their creatinine clearance level. Data in the participant flow section is reported for study discontinuation from the disposition data.

Participant milestones

Measure	Rivaroxaban 10 mg or 7.5 mg Participants with a creatinine clearance (CrCl) greater than or equal to (\>=) 50 milliliter per minute (mL/min) received 10 milligram (mg) rivaroxaban tablet once daily orally and participants with a creatinine clearance from \>=30 to less than (\<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily orally for 45 days.	Placebo Participants received rivaroxaban matched placebo tablet once daily orally for 45 days.
Overall Study STARTED	6007	6012
Overall Study Treated	5982	5980
Overall Study COMPLETED	5876	5869
Overall Study NOT COMPLETED	131	143

Reasons for withdrawal

Measure	Rivaroxaban 10 mg or 7.5 mg Participants with a creatinine clearance (CrCl) greater than or equal to (\>=) 50 milliliter per minute (mL/min) received 10 milligram (mg) rivaroxaban tablet once daily orally and participants with a creatinine clearance from \>=30 to less than (\<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily orally for 45 days.	Placebo Participants received rivaroxaban matched placebo tablet once daily orally for 45 days.
Overall Study Death	109	120
Overall Study Lost to Follow-up	2	3
Overall Study Withdrawal by Subject	20	20

Baseline Characteristics

A Study of Rivaroxaban (JNJ-39039039) on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients

Baseline characteristics by cohort

Measure	Rivaroxaban 10 mg or 7.5 mg n=6007 Participants Participants with a creatinine clearance (CrCl) greater than or equal to (\>=) 50 milliliter per minute (mL/min) received 10 milligram (mg) rivaroxaban tablet once daily orally and participants with a creatinine clearance from \>=30 to less than (\<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily orally for 45 days.	Placebo n=6012 Participants Participants received rivaroxaban matched placebo tablet once daily orally for 45 days.	Total n=12019 Participants Total of all reporting groups
Age, Continuous	69.7 years STANDARD_DEVIATION 10.06 • n=93 Participants	69.7 years STANDARD_DEVIATION 10.22 • n=4 Participants	69.7 years STANDARD_DEVIATION 10.14 • n=27 Participants
Sex: Female, Male Female	2877 Participants n=93 Participants	2858 Participants n=4 Participants	5735 Participants n=27 Participants
Sex: Female, Male Male	3130 Participants n=93 Participants	3154 Participants n=4 Participants	6284 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	499 Participants n=93 Participants	482 Participants n=4 Participants	981 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5490 Participants n=93 Participants	5510 Participants n=4 Participants	11000 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	18 Participants n=93 Participants	20 Participants n=4 Participants	38 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	9 Participants n=93 Participants	5 Participants n=4 Participants	14 Participants n=27 Participants
Race (NIH/OMB) Asian	8 Participants n=93 Participants	8 Participants n=4 Participants	16 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	128 Participants n=93 Participants	123 Participants n=4 Participants	251 Participants n=27 Participants
Race (NIH/OMB) Black or African American	71 Participants n=93 Participants	57 Participants n=4 Participants	128 Participants n=27 Participants
Race (NIH/OMB) White	5782 Participants n=93 Participants	5808 Participants n=4 Participants	11590 Participants n=27 Participants
Race (NIH/OMB) More than one race	6 Participants n=93 Participants	9 Participants n=4 Participants	15 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants
Region of Enrollment ARGENTINA	120 Participants n=93 Participants	122 Participants n=4 Participants	242 Participants n=27 Participants
Region of Enrollment AUSTRALIA	45 Participants n=93 Participants	43 Participants n=4 Participants	88 Participants n=27 Participants
Region of Enrollment AUSTRIA	6 Participants n=93 Participants	8 Participants n=4 Participants	14 Participants n=27 Participants
Region of Enrollment BELARUS	67 Participants n=93 Participants	66 Participants n=4 Participants	133 Participants n=27 Participants
Region of Enrollment BOSNIA-HERZEGOVINA	298 Participants n=93 Participants	299 Participants n=4 Participants	597 Participants n=27 Participants
Region of Enrollment BRAZIL	46 Participants n=93 Participants	46 Participants n=4 Participants	92 Participants n=27 Participants
Region of Enrollment BULGARIA	714 Participants n=93 Participants	714 Participants n=4 Participants	1428 Participants n=27 Participants
Region of Enrollment CANADA	21 Participants n=93 Participants	22 Participants n=4 Participants	43 Participants n=27 Participants
Region of Enrollment COLOMBIA	70 Participants n=93 Participants	70 Participants n=4 Participants	140 Participants n=27 Participants
Region of Enrollment CROATIA	135 Participants n=93 Participants	135 Participants n=4 Participants	270 Participants n=27 Participants
Region of Enrollment CZECH REPUBLIC	115 Participants n=93 Participants	116 Participants n=4 Participants	231 Participants n=27 Participants
Region of Enrollment DENMARK	3 Participants n=93 Participants	4 Participants n=4 Participants	7 Participants n=27 Participants
Region of Enrollment ESTONIA	5 Participants n=93 Participants	6 Participants n=4 Participants	11 Participants n=27 Participants
Region of Enrollment GEORGIA	880 Participants n=93 Participants	882 Participants n=4 Participants	1762 Participants n=27 Participants
Region of Enrollment GERMANY	8 Participants n=93 Participants	9 Participants n=4 Participants	17 Participants n=27 Participants
Region of Enrollment GREECE	66 Participants n=93 Participants	65 Participants n=4 Participants	131 Participants n=27 Participants
Region of Enrollment HUNGARY	275 Participants n=93 Participants	274 Participants n=4 Participants	549 Participants n=27 Participants
Region of Enrollment ISRAEL	55 Participants n=93 Participants	56 Participants n=4 Participants	111 Participants n=27 Participants
Region of Enrollment ITALY	74 Participants n=93 Participants	73 Participants n=4 Participants	147 Participants n=27 Participants
Region of Enrollment LATVIA	154 Participants n=93 Participants	154 Participants n=4 Participants	308 Participants n=27 Participants
Region of Enrollment LITHUANIA	82 Participants n=93 Participants	82 Participants n=4 Participants	164 Participants n=27 Participants
Region of Enrollment MEXICO	17 Participants n=93 Participants	15 Participants n=4 Participants	32 Participants n=27 Participants
Region of Enrollment NETHERLANDS	8 Participants n=93 Participants	9 Participants n=4 Participants	17 Participants n=27 Participants
Region of Enrollment PERU	33 Participants n=93 Participants	32 Participants n=4 Participants	65 Participants n=27 Participants
Region of Enrollment POLAND	310 Participants n=93 Participants	309 Participants n=4 Participants	619 Participants n=27 Participants
Region of Enrollment PORTUGAL	6 Participants n=93 Participants	7 Participants n=4 Participants	13 Participants n=27 Participants
Region of Enrollment PUERTO RICO	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Region of Enrollment REPUBLIC OF MACEDONIA	451 Participants n=93 Participants	451 Participants n=4 Participants	902 Participants n=27 Participants
Region of Enrollment ROMANIA	162 Participants n=93 Participants	162 Participants n=4 Participants	324 Participants n=27 Participants
Region of Enrollment RUSSIAN FEDERATION	571 Participants n=93 Participants	571 Participants n=4 Participants	1142 Participants n=27 Participants
Region of Enrollment SERBIA	305 Participants n=93 Participants	304 Participants n=4 Participants	609 Participants n=27 Participants
Region of Enrollment SOUTH AFRICA	103 Participants n=93 Participants	102 Participants n=4 Participants	205 Participants n=27 Participants
Region of Enrollment SPAIN	192 Participants n=93 Participants	191 Participants n=4 Participants	383 Participants n=27 Participants
Region of Enrollment TURKEY	35 Participants n=93 Participants	35 Participants n=4 Participants	70 Participants n=27 Participants
Region of Enrollment UKRAINE	426 Participants n=93 Participants	428 Participants n=4 Participants	854 Participants n=27 Participants
Region of Enrollment UNITED KINGDOM	4 Participants n=93 Participants	4 Participants n=4 Participants	8 Participants n=27 Participants
Region of Enrollment UNITED STATES	145 Participants n=93 Participants	145 Participants n=4 Participants	290 Participants n=27 Participants

PRIMARY outcome

Timeframe: Up to Day 45

Population: Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.

Symptomatic VTE included lower extremity deep vein thrombosis (DVT) and non-fatal pulmonary embolism (PE). Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45.

Outcome measures

Measure	Rivaroxaban 10 mg or 7.5 mg n=6007 Participants Participants with a creatinine clearance (CrCl) greater than or equal to (\>=) 50 milliliter per minute (mL/min) received 10 milligram (mg) rivaroxaban tablet once daily orally and participants with a creatinine clearance from \>=30 to less than (\<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily orally for 45 days.	Placebo n=6012 Participants Participants received rivaroxaban matched placebo tablet once daily orally for 45 days.
Time From Randomization to First Occurrence of Composite of All Symptomatic Venous Thromboembolism (VTE) and VTE Related Death Adjudicated by Clinical Event Committee (CEC)	0.84 Events per 100 participants in 45 days	1.11 Events per 100 participants in 45 days

PRIMARY outcome

Timeframe: From randomization to 2 days after the last dose (Day 45)

Population: The Safety analysis set included all enrolled participants in the ITT analysis set who received at least 1 dose of study drug.

A major bleeding event was defined using validated International Society on Thrombosis and Haemostasis (ISTH) bleeding criteria. A major bleeding event was defined as overt bleeding that was associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or more, or a transfusion of 2 or more units of packed red blood cells or whole blood, or a critical site defined as intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or a fatal outcome. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or last dose + 2 days.

Outcome measures

Measure	Rivaroxaban 10 mg or 7.5 mg n=5982 Participants Participants with a creatinine clearance (CrCl) greater than or equal to (\>=) 50 milliliter per minute (mL/min) received 10 milligram (mg) rivaroxaban tablet once daily orally and participants with a creatinine clearance from \>=30 to less than (\<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily orally for 45 days.	Placebo n=5980 Participants Participants received rivaroxaban matched placebo tablet once daily orally for 45 days.
Event Rate Based on Time From Randomization to the First Occurrence of Major Bleeding Adjudicated by CEC	0.28 Events per 100 participants in 45 days	0.15 Events per 100 participants in 45 days

SECONDARY outcome

Timeframe: Up to Day 45

Population: ITT analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.

Event rate based on time from randomization to first occurrence of VTE-related death (adjudicated by CEC) was assessed. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45.

Outcome measures

Measure	Rivaroxaban 10 mg or 7.5 mg n=6007 Participants Participants with a creatinine clearance (CrCl) greater than or equal to (\>=) 50 milliliter per minute (mL/min) received 10 milligram (mg) rivaroxaban tablet once daily orally and participants with a creatinine clearance from \>=30 to less than (\<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily orally for 45 days.	Placebo n=6012 Participants Participants received rivaroxaban matched placebo tablet once daily orally for 45 days.
Event Rate Based on Time From Randomization to First Occurrence of VTE-Related Death Adjudicated by CEC	0.72 Events per 100 participants in 45 days	0.77 Events per 100 participants in 45 days

SECONDARY outcome

Timeframe: Up to Day 45

Population: ITT analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.

Event rate based on time from randomization to the first occurrence of a symptomatic VTE (adjudicated by CEC) was assessed. Symptomatic VTE included lower extremity DVT and non-fatal PE. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45.

Outcome measures

Measure	Rivaroxaban 10 mg or 7.5 mg n=6007 Participants Participants with a creatinine clearance (CrCl) greater than or equal to (\>=) 50 milliliter per minute (mL/min) received 10 milligram (mg) rivaroxaban tablet once daily orally and participants with a creatinine clearance from \>=30 to less than (\<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily orally for 45 days.	Placebo n=6012 Participants Participants received rivaroxaban matched placebo tablet once daily orally for 45 days.
Event Rate Based on Time From Randomization to the First Occurrence of a Symptomatic Venous Thromboembolism Event (VTE) Adjudicated by CEC	0.19 Events per 100 participants in 45 days	0.42 Events per 100 participants in 45 days

SECONDARY outcome

Timeframe: Up to Day 45

Population: ITT analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.

Event rate based on time from randomization to the first occurrence of a composite of symptomatic VTE and ACM (adjudicated by CEC) was assessed. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45.

Outcome measures

Measure	Rivaroxaban 10 mg or 7.5 mg n=6007 Participants Participants with a creatinine clearance (CrCl) greater than or equal to (\>=) 50 milliliter per minute (mL/min) received 10 milligram (mg) rivaroxaban tablet once daily orally and participants with a creatinine clearance from \>=30 to less than (\<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily orally for 45 days.	Placebo n=6012 Participants Participants received rivaroxaban matched placebo tablet once daily orally for 45 days.
Event Rate Based on Time From Randomization to the First Occurrence of a Composite of Symptomatic VTE and All-Cause Mortality (ACM) Adjudicated by CEC	1.31 Events per 100 participants in 45 days	1.80 Events per 100 participants in 45 days

SECONDARY outcome

Timeframe: Up to Day 45

Population: ITT analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.

Event rate based on time from randomization to the first occurrence of a composite of symptomatic VTE (lower extremity DVT and non-fatal PE), MI, non-hemorrhagic stroke, and CV death (death due to a known CV cause and death in which a CV cause cannot be ruled out; by this definition, a VTE-related death was considered a CV death) as adjudicated by CEC was reported. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45.

Outcome measures

Measure	Rivaroxaban 10 mg or 7.5 mg n=6007 Participants Participants with a creatinine clearance (CrCl) greater than or equal to (\>=) 50 milliliter per minute (mL/min) received 10 milligram (mg) rivaroxaban tablet once daily orally and participants with a creatinine clearance from \>=30 to less than (\<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily orally for 45 days.	Placebo n=6012 Participants Participants received rivaroxaban matched placebo tablet once daily orally for 45 days.
Event Rate Based on Time From Randomization to the First Occurrence of a Composite of Symptomatic VTE, Myocardial Infarction (MI), Non-Hemorrhagic Stroke, and Cardiovascular (CV) Death Adjudicated by CEC	1.58 Events per 100 participants in 45 days	2.03 Events per 100 participants in 45 days

SECONDARY outcome

Timeframe: Up to Day 45

Population: ITT analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.

Event rate based on time from randomization to first occurrence of ACM (adjudicated by CEC) was assessed. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45.

Outcome measures

Measure	Rivaroxaban 10 mg or 7.5 mg n=6007 Participants Participants with a creatinine clearance (CrCl) greater than or equal to (\>=) 50 milliliter per minute (mL/min) received 10 milligram (mg) rivaroxaban tablet once daily orally and participants with a creatinine clearance from \>=30 to less than (\<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily orally for 45 days.	Placebo n=6012 Participants Participants received rivaroxaban matched placebo tablet once daily orally for 45 days.
Event Rate Based on Time From Randomization to First Occurrence of All-Cause Mortality (ACM) Adjudicated by CEC	1.19 Events per 100 participants in 45 days	1.49 Events per 100 participants in 45 days

Adverse Events

Rivaroxaban 10 mg or 7.5 mg

Serious events: 475 serious events

Other events: 250 other events

Deaths: 115 deaths

Placebo

Serious events: 493 serious events

Other events: 280 other events

Deaths: 126 deaths

Serious adverse events

Measure	Rivaroxaban 10 mg or 7.5 mg n=6007 participants at risk Participants with a creatinine clearance (CrCl) greater than or equal to (\>=) 50 milliliter per minute (mL/min) received 10 milligram (mg) rivaroxaban tablet once daily orally and participants with a creatinine clearance from \>=30 to less than (\<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily orally for 45 days.	Placebo n=6012 participants at risk Participants received rivaroxaban matched placebo tablet once daily orally for 45 days.
Injury, poisoning and procedural complications Femoral Neck Fracture	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.03% 2/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Injury, poisoning and procedural complications Femur Fracture	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.05% 3/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Injury, poisoning and procedural complications Head Injury	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.03% 2/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Injury, poisoning and procedural complications Hip Fracture	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.03% 2/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Injury, poisoning and procedural complications Humerus Fracture	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Injury, poisoning and procedural complications Intestinal Anastomosis Complication	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Pyelonephritis Chronic	0.03% 2/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Pyoderma	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Respiratory Tract Infection	0.05% 3/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.05% 3/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Sepsis	0.07% 4/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.05% 3/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Septic Shock	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.07% 4/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Tuberculous Pleurisy	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Upper Respiratory Tract Infection	0.03% 2/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Sinusitis	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Soft Tissue Infection	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Splenic Abscess	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Staphylococcal Bacteraemia	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Urinary Tract Infection	0.18% 11/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.18% 11/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Urinary Tract Infection Bacterial	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Urosepsis	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.07% 4/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Viral Infection	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Wound Infection	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Wound Infection Staphylococcal	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Injury, poisoning and procedural complications Accidental Overdose	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Injury, poisoning and procedural complications Cervical Vertebral Fracture	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Injury, poisoning and procedural complications Fall	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Staphylococcal Sepsis	0.03% 2/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Systemic Infection	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Blood and lymphatic system disorders Anaemia	0.05% 3/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Blood and lymphatic system disorders Autoimmune Haemolytic Anaemia	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Blood and lymphatic system disorders Haemorrhagic Anaemia	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Blood and lymphatic system disorders Iron Deficiency Anaemia	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Acute Left Ventricular Failure	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Angina Pectoris	0.05% 3/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Aortic Valve Incompetence	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Atrial Fibrillation	0.22% 13/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.17% 10/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Atrial Flutter	0.05% 3/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.10% 6/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Atrioventricular Block Complete	0.07% 4/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Atrioventricular Block Second Degree	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Bradyarrhythmia	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Bradycardia	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.03% 2/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Cardiac Arrest	0.08% 5/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.08% 5/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Cardiac Asthma	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Cardiac Failure	0.85% 51/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	1.0% 62/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Cardiac Failure Acute	0.23% 14/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.23% 14/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Cardiac Failure Chronic	0.22% 13/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.13% 8/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Cardiac Failure Congestive	0.40% 24/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.42% 25/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Cardiac Valve Disease	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Cardiac Ventricular Thrombosis	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Cardio-Respiratory Arrest	0.08% 5/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.03% 2/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Cardiogenic Shock	0.07% 4/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.03% 2/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Cardiomyopathy	0.03% 2/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Cardiomyopathy Acute	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Cardiopulmonary Failure	0.07% 4/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.07% 4/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Congestive Cardiomyopathy	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.03% 2/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Cor Pulmonale	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Coronary Artery Disease	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Coronary Artery Stenosis	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Diastolic Dysfunction	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Hypertensive Heart Disease	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Interventricular Septum Rupture	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Ischaemic Cardiomyopathy	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Left Ventricular Failure	0.07% 4/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.03% 2/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Mitral Valve Incompetence	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Myocardial Fibrosis	0.03% 2/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Myocardial Ischaemia	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Myocarditis	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Nodal Rhythm	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Pericarditis	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Right Ventricular Failure	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Sinus Bradycardia	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Sinus Node Dysfunction	0.03% 2/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Supraventricular Tachycardia	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.05% 3/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Tachycardia	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Ventricular Extrasystoles	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.03% 2/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Cardiac disorders Ventricular Tachycardia	0.05% 3/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Ear and labyrinth disorders Motion Sickness	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Ear and labyrinth disorders Vertigo	0.03% 2/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Ear and labyrinth disorders Vertigo Positional	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Eye disorders Conjunctival Oedema	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Eye disorders Exophthalmos	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Eye disorders Retinal Artery Occlusion	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Gastrointestinal disorders Abdominal Incarcerated Hernia	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Gastrointestinal disorders Abdominal Pain	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Gastrointestinal disorders Acute Abdomen	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Gastrointestinal disorders Ascites	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Gastrointestinal disorders Chronic Gastritis	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Gastrointestinal disorders Colitis Ischaemic	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Gastrointestinal disorders Diarrhoea	0.05% 3/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Gastrointestinal disorders Duodenal Ulcer	0.03% 2/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.03% 2/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Gastrointestinal disorders Dyspepsia	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Gastrointestinal disorders Dysphagia	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Gastrointestinal disorders Enterocolitis	0.03% 2/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.03% 2/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Gastrointestinal disorders Enterocolitis Haemorrhagic	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Gastrointestinal disorders Enterovesical Fistula	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Gastrointestinal disorders Gastric Polyps	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Gastrointestinal disorders Gastric Ulcer	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Gastrointestinal disorders Gastritis	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Gastrointestinal disorders Haemorrhoids	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Gastrointestinal disorders Ileus	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Gastrointestinal disorders Inguinal Hernia	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Gastrointestinal disorders Intestinal Ischaemia	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Gastrointestinal disorders Pancreatic Disorder	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Gastrointestinal disorders Pancreatitis	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Gastrointestinal disorders Pancreatitis Acute	0.03% 2/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.03% 2/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Gastrointestinal disorders Peptic Ulcer	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Gastrointestinal disorders Peptic Ulcer Haemorrhage	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Gastrointestinal disorders Peptic Ulcer Perforation	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Gastrointestinal disorders Rectal Polyp	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Gastrointestinal disorders Small Intestinal Obstruction	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.03% 2/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Gastrointestinal disorders Subileus	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Gastrointestinal disorders Vomiting	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
General disorders Asthenia	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
General disorders Chest Pain	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
General disorders Death	0.42% 25/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.50% 30/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
General disorders Fatigue	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.03% 2/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
General disorders Multiple Organ Dysfunction Syndrome	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.03% 2/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
General disorders Oedema Peripheral	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
General disorders Peripheral Swelling	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
General disorders Pyrexia	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.05% 3/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
General disorders Sudden Cardiac Death	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.03% 2/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
General disorders Systemic Inflammatory Response Syndrome	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Hepatobiliary disorders Bile Duct Obstruction	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Hepatobiliary disorders Bile Duct Stone	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.03% 2/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Hepatobiliary disorders Cholecystitis	0.03% 2/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.05% 3/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Hepatobiliary disorders Cholecystitis Acute	0.03% 2/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Hepatobiliary disorders Cholecystitis Chronic	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Hepatobiliary disorders Cholelithiasis	0.03% 2/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.03% 2/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Hepatobiliary disorders Hepatic Lesion	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Immune system disorders Anaphylactic Reaction	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Abdominal Abscess	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Abscess Limb	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Anal Abscess	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Breast Cellulitis	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Bronchitis	0.08% 5/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.05% 3/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Bronchopulmonary Aspergillosis	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Cellulitis	0.18% 11/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.17% 10/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Clostridium Difficile Colitis	0.03% 2/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Clostridium Difficile Infection	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Diabetic Foot Infection	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Diverticulitis	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Empyema	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Endocarditis	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.03% 2/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Endocarditis Bacterial	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Endophthalmitis	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Endotoxic Shock	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Erysipelas	0.05% 3/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.07% 4/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Tracheobronchitis	0.03% 2/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Fungal Oesophagitis	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Fungal Skin Infection	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Gastroenteritis	0.03% 2/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.05% 3/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Gastroenteritis Salmonella	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Gastroenteritis Viral	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Haematoma Infection	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Helicobacter Infection	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Infection	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Infectious Colitis	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Infectious Pleural Effusion	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Infective Exacerbation of Bronchiectasis	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Infective Exacerbation of Chronic Obstructive Airways Disease	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.07% 4/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Infective Spondylitis	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Influenza	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Injection Site Abscess	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Intervertebral Discitis	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.03% 2/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Lower Respiratory Tract Infection	0.03% 2/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Lung Abscess	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Lung Infection	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Mediastinitis	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Osteomyelitis	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Parotitis	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Pneumonia	0.97% 58/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.80% 48/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Pneumonia Bacterial	0.03% 2/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.07% 4/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Pneumonia Pseudomonal	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Pneumonia Staphylococcal	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Postoperative Wound Infection	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Pulmonary Sepsis	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.03% 2/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Pulmonary Tuberculosis	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Infections and infestations Pyelonephritis	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.03% 2/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Injury, poisoning and procedural complications Laceration	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Injury, poisoning and procedural complications Ligament Rupture	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Injury, poisoning and procedural complications Lower Limb Fracture	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Injury, poisoning and procedural complications Lumbar Vertebral Fracture	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Injury, poisoning and procedural complications Multiple Injuries	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Injury, poisoning and procedural complications Nerve Injury	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Injury, poisoning and procedural complications Procedural Pneumothorax	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Injury, poisoning and procedural complications Rib Fracture	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Injury, poisoning and procedural complications Soft Tissue Injury	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Injury, poisoning and procedural complications Tendon Injury	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Injury, poisoning and procedural complications Toxicity to Various Agents	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Injury, poisoning and procedural complications Traumatic Lung Injury	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Injury, poisoning and procedural complications Twiddler's Syndrome	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Investigations Aspiration Bronchial	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Investigations Body Temperature Increased	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.03% 2/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Investigations Cardiac Output Decreased	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Investigations Myocardial Necrosis Marker Increased	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Metabolism and nutrition disorders Dehydration	0.03% 2/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.05% 3/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Metabolism and nutrition disorders Diabetes Mellitus	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Metabolism and nutrition disorders Diabetes Mellitus Inadequate Control	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Metabolism and nutrition disorders Diabetic Metabolic Decompensation	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Metabolism and nutrition disorders Failure to Thrive	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Metabolism and nutrition disorders Fluid Overload	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Metabolism and nutrition disorders Gout	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.03% 2/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Metabolism and nutrition disorders Hyperglycaemia	0.03% 2/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Metabolism and nutrition disorders Hyperkalaemia	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Metabolism and nutrition disorders Hypoalbuminaemia	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Metabolism and nutrition disorders Hypoglycaemia	0.05% 3/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.08% 5/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Metabolism and nutrition disorders Hyponatraemia	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Metabolism and nutrition disorders Overweight	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Metabolism and nutrition disorders Type 2 Diabetes Mellitus	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Metabolism and nutrition disorders Vitamin B12 Deficiency	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Musculoskeletal and connective tissue disorders Back Pain	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Musculoskeletal and connective tissue disorders Compartment Syndrome	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.03% 2/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.03% 2/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Musculoskeletal and connective tissue disorders Rheumatoid Arthritis	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.05% 3/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Musculoskeletal and connective tissue disorders Vertebral Lesion	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute Leukaemia	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of Colon	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Cancer Recurrent	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Neoplasm	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.03% 2/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Neoplasm	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer Metastatic	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric Cancer	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic Cancer Metastatic	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive Ductal Breast Carcinoma	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Cancer Metastatic	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.03% 2/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Infiltration Malignant	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Neoplasm	0.03% 2/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Neoplasm Malignant	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.08% 5/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Neoplasm of Unknown Primary Site	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Pleural Effusion	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mediastinum Neoplasm	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic Neoplasm	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's Lymphoma	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Small Cell Lung Cancer	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian Cancer	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma Cell Myeloma	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Cancer	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Neoplasm	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectosigmoid Cancer	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Neoplasm	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma of Lung	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Nervous system disorders Aphasia	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Nervous system disorders Carotid Artery Occlusion	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Nervous system disorders Carotid Artery Stenosis	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Nervous system disorders Craniocervical Syndrome	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Nervous system disorders Demyelinating Polyneuropathy	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Nervous system disorders Encephalopathy	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Nervous system disorders Epilepsy	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Nervous system disorders Facial Paralysis	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Nervous system disorders Headache	0.03% 2/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Nervous system disorders Hypoglycaemic Coma	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Nervous system disorders Hypoglycaemic Encephalopathy	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Nervous system disorders Ischaemic Stroke	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Nervous system disorders Lumbar Radiculopathy	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Nervous system disorders Orthostatic Intolerance	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Nervous system disorders Presyncope	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Nervous system disorders Sciatica	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Nervous system disorders Seizure	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Nervous system disorders Syncope	0.10% 6/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.08% 5/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Nervous system disorders Vascular Encephalopathy	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Nervous system disorders Vertebral Artery Stenosis	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Nervous system disorders Vertigo CNS Origin	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Product Issues Device Dislocation	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Product Issues Device Failure	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Product Issues Device Occlusion	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Psychiatric disorders Anxiety	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Psychiatric disorders Conversion Disorder	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Psychiatric disorders Panic Attack	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Renal and urinary disorders Acute Kidney Injury	0.12% 7/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.13% 8/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Renal and urinary disorders Chronic Kidney Disease	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.03% 2/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Renal and urinary disorders Ketonuria	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Renal and urinary disorders Nephritis	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Renal and urinary disorders Nephrolithiasis	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Renal and urinary disorders Nephrotic Syndrome	0.03% 2/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Renal and urinary disorders Renal Failure	0.05% 3/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.05% 3/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Renal and urinary disorders Renal Impairment	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.03% 2/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Renal and urinary disorders Urinary Retention	0.05% 3/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Respiratory, thoracic and mediastinal disorders Acute Pulmonary Oedema	0.07% 4/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.12% 7/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.15% 9/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Respiratory, thoracic and mediastinal disorders Asthma	0.13% 8/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.05% 3/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.03% 2/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Respiratory, thoracic and mediastinal disorders Bronchitis Chronic	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.05% 3/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	1.3% 81/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	1.3% 77/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Respiratory, thoracic and mediastinal disorders Chronic Respiratory Failure	0.07% 4/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.08% 5/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Respiratory, thoracic and mediastinal disorders Interstitial Lung Disease	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Respiratory, thoracic and mediastinal disorders Lupus Pleurisy	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Respiratory, thoracic and mediastinal disorders Pickwickian Syndrome	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.03% 2/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.05% 3/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Respiratory, thoracic and mediastinal disorders Pneumonia Aspiration	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.05% 3/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Respiratory, thoracic and mediastinal disorders Pneumothorax Spontaneous	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Respiratory, thoracic and mediastinal disorders Pulmonary Arterial Hypertension	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Respiratory, thoracic and mediastinal disorders Pulmonary Congestion	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Respiratory, thoracic and mediastinal disorders Pulmonary Fibrosis	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Respiratory, thoracic and mediastinal disorders Pulmonary Mass	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Respiratory, thoracic and mediastinal disorders Pulmonary Oedema	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.07% 4/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Respiratory, thoracic and mediastinal disorders Pulmonary Pneumatocele	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Respiratory, thoracic and mediastinal disorders Respiratory Distress	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.15% 9/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.13% 8/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Skin and subcutaneous tissue disorders Angioedema	0.03% 2/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Skin and subcutaneous tissue disorders Dermatitis Allergic	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Skin and subcutaneous tissue disorders Diabetic Foot	0.03% 2/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Skin and subcutaneous tissue disorders Rash	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Skin and subcutaneous tissue disorders Skin Necrosis	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Skin and subcutaneous tissue disorders Skin Ulcer	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.03% 2/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Skin and subcutaneous tissue disorders Vasculitic Ulcer	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Social circumstances Bereavement	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Social circumstances Immobile	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Surgical and medical procedures Hospitalisation	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Vascular disorders Aortic Dissection	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Vascular disorders Aortic Stenosis	0.03% 2/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Vascular disorders Arterial Stenosis	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Vascular disorders Distributive Shock	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Vascular disorders Hypertension	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.03% 2/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Vascular disorders Hypertensive Crisis	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.05% 3/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Vascular disorders Hypotension	0.08% 5/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.05% 3/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Vascular disorders Peripheral Arterial Occlusive Disease	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Vascular disorders Peripheral Artery Occlusion	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Vascular disorders Peripheral Artery Thrombosis	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.03% 2/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Vascular disorders Peripheral Ischaemia	0.00% 0/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.02% 1/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Vascular disorders Post Thrombotic Syndrome	0.02% 1/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.00% 0/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.

Other adverse events

Measure	Rivaroxaban 10 mg or 7.5 mg n=6007 participants at risk Participants with a creatinine clearance (CrCl) greater than or equal to (\>=) 50 milliliter per minute (mL/min) received 10 milligram (mg) rivaroxaban tablet once daily orally and participants with a creatinine clearance from \>=30 to less than (\<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily orally for 45 days.	Placebo n=6012 participants at risk Participants received rivaroxaban matched placebo tablet once daily orally for 45 days.
Gastrointestinal disorders Diarrhoea	1.1% 69/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	0.86% 52/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Nervous system disorders Headache	1.9% 114/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	2.4% 147/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.
Vascular disorders Hypertension	1.2% 75/6007 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.	1.5% 93/6012 • Up to 75 days (+/-5 days) Intention-to-treat (ITT) analysis set comprised all randomized participants who signed a valid informed consent, regardless of actual treatment received.

Additional Information

Clinical Leader

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: ClinicalTrialDisclosure@its.jnj.com

Results disclosure agreements

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

Restriction type: OTHER