Trial Outcomes & Findings for A Study Exploring Two Strategies of Rivaroxaban (JNJ39039039; BAY-59-7939) and One of Oral Vitamin K Antagonist in Patients With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention (NCT NCT01830543)
NCT ID: NCT01830543
Last Updated: 2017-09-19
Results Overview
Clinically significant bleeding is a composite of Thrombolysis in Myocardial Infarction (TIMI) major bleeding, minor bleeding, and bleeding requiring medical attention (BRMA). TIMI major bleeding is defined as any symptomatic intracranial hemorrhage, clinically overt signs of hemorrhage (including imaging) associated with a drop in hemoglobin of greater than or equal to (\>=) 5 grams per deciliter (g/dL) (or when the hemoglobin concentration is not available, an absolute drop in hematocrit of \>=15 percent (%)). TIMI minor bleeding event is defined as any clinically overt sign of hemorrhage (including imaging) that is associated with a fall in hemoglobin concentration of 3 to less than (\<) 5 g/dL (or, when hemoglobin concentration is not available, a fall in hematocrit of 9 percent to \<15 percent). A BRMA event is defined as any bleeding event that requires medical treatment, surgical treatment, or laboratory evaluation, and does not meet criteria for a major or minor bleeding event.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2124 participants
Primary outcome timeframe
Up to Month 12
Results posted on
2017-09-19
Participant Flow
Participant milestones
| Measure |
Rivaroxaban 15 mg
Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment \[creatinine clearance (CrCl): 30 to less than (\<) 50 milliliter per minute (mL/min)\]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
|
Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)
Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor \[prasugrel or ticagrelor\]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
|
Vitamin K Antagonist (VKA)
Participants received dose adjusted (to a target of international normalized ratio \[INR\] 2.0 to 3.0 \[or target INR 2.0 to 2.5\]) vitamin K antagonist (VKA) \[example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg \[or alternate P2Y12 inhibitor (prasugrel or ticagrelor)\] plus low-dose ASA \[75 to 100 mg\] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
|
|---|---|---|---|
|
Overall Study
STARTED
|
709
|
709
|
706
|
|
Overall Study
Treated
|
696
|
706
|
697
|
|
Overall Study
COMPLETED
|
550
|
557
|
492
|
|
Overall Study
NOT COMPLETED
|
159
|
152
|
214
|
Reasons for withdrawal
| Measure |
Rivaroxaban 15 mg
Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment \[creatinine clearance (CrCl): 30 to less than (\<) 50 milliliter per minute (mL/min)\]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
|
Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)
Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor \[prasugrel or ticagrelor\]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
|
Vitamin K Antagonist (VKA)
Participants received dose adjusted (to a target of international normalized ratio \[INR\] 2.0 to 3.0 \[or target INR 2.0 to 2.5\]) vitamin K antagonist (VKA) \[example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg \[or alternate P2Y12 inhibitor (prasugrel or ticagrelor)\] plus low-dose ASA \[75 to 100 mg\] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
|
|---|---|---|---|
|
Overall Study
Subject Decision
|
19
|
21
|
57
|
|
Overall Study
Adverse Event
|
91
|
77
|
76
|
|
Overall Study
Death
|
20
|
22
|
22
|
|
Overall Study
Protocol Violation
|
3
|
7
|
7
|
|
Overall Study
Physician Decision
|
11
|
5
|
12
|
|
Overall Study
Withdrawal by consent
|
3
|
3
|
3
|
|
Overall Study
Other
|
12
|
17
|
37
|
Baseline Characteristics
A Study Exploring Two Strategies of Rivaroxaban (JNJ39039039; BAY-59-7939) and One of Oral Vitamin K Antagonist in Patients With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention
Baseline characteristics by cohort
| Measure |
Rivaroxaban 15 mg
n=709 Participants
Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment \[creatinine clearance (CrCl): 30 to less than (\<) 50 milliliter per minute (mL/min)\]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
|
Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)
n=709 Participants
Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor \[prasugrel or ticagrelor\]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
|
Vitamin K Antagonist (VKA)
n=706 Participants
Participants received dose adjusted (to a target of international normalized ratio \[INR\] 2.0 to 3.0 \[or target INR 2.0 to 2.5\]) vitamin K antagonist (VKA) \[example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg \[or alternate P2Y12 inhibitor (prasugrel or ticagrelor)\] plus low-dose ASA \[75 to 100 mg\] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
|
Total
n=2124 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
70.4 years
STANDARD_DEVIATION 9.12 • n=5 Participants
|
70 years
STANDARD_DEVIATION 9.11 • n=7 Participants
|
69.9 years
STANDARD_DEVIATION 8.67 • n=5 Participants
|
70.1 years
STANDARD_DEVIATION 8.97 • n=4 Participants
|
|
Sex: Female, Male
Female
|
181 Participants
n=5 Participants
|
174 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
543 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
528 Participants
n=5 Participants
|
535 Participants
n=7 Participants
|
518 Participants
n=5 Participants
|
1581 Participants
n=4 Participants
|
|
Region of Enrollment
Argentina
|
32 participants
n=5 Participants
|
27 participants
n=7 Participants
|
23 participants
n=5 Participants
|
82 participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
3 participants
n=5 Participants
|
7 participants
n=7 Participants
|
5 participants
n=5 Participants
|
15 participants
n=4 Participants
|
|
Region of Enrollment
Belgium
|
14 participants
n=5 Participants
|
18 participants
n=7 Participants
|
20 participants
n=5 Participants
|
52 participants
n=4 Participants
|
|
Region of Enrollment
Brazil
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
13 participants
n=5 Participants
|
41 participants
n=4 Participants
|
|
Region of Enrollment
Bulgaria
|
67 participants
n=5 Participants
|
80 participants
n=7 Participants
|
74 participants
n=5 Participants
|
221 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
23 participants
n=5 Participants
|
24 participants
n=7 Participants
|
19 participants
n=5 Participants
|
66 participants
n=4 Participants
|
|
Region of Enrollment
Chile
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
6 participants
n=5 Participants
|
18 participants
n=4 Participants
|
|
Region of Enrollment
Czech Republic
|
17 participants
n=5 Participants
|
9 participants
n=7 Participants
|
14 participants
n=5 Participants
|
40 participants
n=4 Participants
|
|
Region of Enrollment
Denmark
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
12 participants
n=4 Participants
|
|
Region of Enrollment
France
|
33 participants
n=5 Participants
|
26 participants
n=7 Participants
|
25 participants
n=5 Participants
|
84 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
96 participants
n=5 Participants
|
98 participants
n=7 Participants
|
101 participants
n=5 Participants
|
295 participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
26 participants
n=5 Participants
|
26 participants
n=7 Participants
|
20 participants
n=5 Participants
|
72 participants
n=4 Participants
|
|
Region of Enrollment
Korea, Republic of
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
17 participants
n=5 Participants
|
39 participants
n=4 Participants
|
|
Region of Enrollment
Malaysia
|
1 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
Region of Enrollment
Mexico
|
7 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
13 participants
n=4 Participants
|
|
Region of Enrollment
Netherlands
|
24 participants
n=5 Participants
|
17 participants
n=7 Participants
|
27 participants
n=5 Participants
|
68 participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
71 participants
n=5 Participants
|
78 participants
n=7 Participants
|
69 participants
n=5 Participants
|
218 participants
n=4 Participants
|
|
Region of Enrollment
Romania
|
15 participants
n=5 Participants
|
16 participants
n=7 Participants
|
19 participants
n=5 Participants
|
50 participants
n=4 Participants
|
|
Region of Enrollment
Russian Federation
|
90 participants
n=5 Participants
|
86 participants
n=7 Participants
|
89 participants
n=5 Participants
|
265 participants
n=4 Participants
|
|
Region of Enrollment
Sweden
|
15 participants
n=5 Participants
|
14 participants
n=7 Participants
|
18 participants
n=5 Participants
|
47 participants
n=4 Participants
|
|
Region of Enrollment
Taiwan, Province of China
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
9 participants
n=5 Participants
|
25 participants
n=4 Participants
|
|
Region of Enrollment
Turkey
|
11 participants
n=5 Participants
|
14 participants
n=7 Participants
|
18 participants
n=5 Participants
|
43 participants
n=4 Participants
|
|
Region of Enrollment
Ukraine
|
19 participants
n=5 Participants
|
24 participants
n=7 Participants
|
17 participants
n=5 Participants
|
60 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
48 participants
n=5 Participants
|
44 participants
n=7 Participants
|
39 participants
n=5 Participants
|
131 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
56 participants
n=5 Participants
|
49 participants
n=7 Participants
|
46 participants
n=5 Participants
|
151 participants
n=4 Participants
|
|
Region of Enrollment
South Africa
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
5 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to Month 12Population: The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug.
Clinically significant bleeding is a composite of Thrombolysis in Myocardial Infarction (TIMI) major bleeding, minor bleeding, and bleeding requiring medical attention (BRMA). TIMI major bleeding is defined as any symptomatic intracranial hemorrhage, clinically overt signs of hemorrhage (including imaging) associated with a drop in hemoglobin of greater than or equal to (\>=) 5 grams per deciliter (g/dL) (or when the hemoglobin concentration is not available, an absolute drop in hematocrit of \>=15 percent (%)). TIMI minor bleeding event is defined as any clinically overt sign of hemorrhage (including imaging) that is associated with a fall in hemoglobin concentration of 3 to less than (\<) 5 g/dL (or, when hemoglobin concentration is not available, a fall in hematocrit of 9 percent to \<15 percent). A BRMA event is defined as any bleeding event that requires medical treatment, surgical treatment, or laboratory evaluation, and does not meet criteria for a major or minor bleeding event.
Outcome measures
| Measure |
Rivaroxaban 15 mg
n=696 Participants
Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment \[creatinine clearance (CrCl): 30 to less than (\<) 50 milliliter per minute (mL/min)\]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
|
Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)
n=706 Participants
Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor \[prasugrel or ticagrelor\]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
|
Vitamin K Antagonist (VKA)
n=697 Participants
Participants received dose adjusted (to a target of international normalized ratio \[INR\] 2.0 to 3.0 \[or target INR 2.0 to 2.5\]) vitamin K antagonist (VKA) \[example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg \[or alternate P2Y12 inhibitor (prasugrel or ticagrelor)\] plus low-dose ASA \[75 to 100 mg\] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
|
|---|---|---|---|
|
Percentage of Participants With Clinically Significant Bleeding
|
15.7 percentage of participants
|
16.6 percentage of participants
|
24.0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Month 12 and end of DAPT-Month 1, 6 and 12Population: The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here, 'n' signifies number of participants analyzed at specific time-point in this outcome measure.
TIMI major bleeding is defined as any symptomatic intracranial hemorrhage, Clinically overt signs of hemorrhage (including imaging) associated with a drop in hemoglobin of \>= 5 g/dL (or when the hemoglobin concentration is not available, an absolute drop in hematocrit of \>=15 percent).
Outcome measures
| Measure |
Rivaroxaban 15 mg
n=696 Participants
Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment \[creatinine clearance (CrCl): 30 to less than (\<) 50 milliliter per minute (mL/min)\]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
|
Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)
n=706 Participants
Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor \[prasugrel or ticagrelor\]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
|
Vitamin K Antagonist (VKA)
n=697 Participants
Participants received dose adjusted (to a target of international normalized ratio \[INR\] 2.0 to 3.0 \[or target INR 2.0 to 2.5\]) vitamin K antagonist (VKA) \[example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg \[or alternate P2Y12 inhibitor (prasugrel or ticagrelor)\] plus low-dose ASA \[75 to 100 mg\] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
|
|---|---|---|---|
|
Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding
Up to Month 12 (n= 696, 706, 697)
|
2.0 percentage of participants
|
1.7 percentage of participants
|
2.9 percentage of participants
|
|
Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding
End of DAPT-1 Month (n= 0, 108,113)
|
NA percentage of participants
Analysis at end of DAPT-1 month conducted only in participants who received DAPT as part of therapy.
|
0.9 percentage of participants
|
4.4 percentage of participants
|
|
Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding
End of DAPT-6 Month (n= 0, 248,243)
|
NA percentage of participants
Analysis at end of DAPT-6 month conducted only in participants who received DAPT as part of therapy.
|
2.8 percentage of participants
|
3.7 percentage of participants
|
|
Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding
End of DAPT-12 Month (n= 0, 350,341)
|
NA percentage of participants
Analysis at end of DAPT-12 month conducted only in participants who received DAPT as part of therapy.
|
1.1 percentage of participants
|
1.8 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Month 12 and end of DAPT-Month 1, 6 and 12Population: The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'n' signifies number of participants analyzed at specific time-point in this outcome measure.
TIMI minor bleeding event is defined as any clinically overt sign of hemorrhage (including imaging) that is associated with a fall in hemoglobin concentration of 3 to \<5 g/dL (or, when hemoglobin concentration is not available, a fall in hematocrit of 9 percent to \<15 percent).
Outcome measures
| Measure |
Rivaroxaban 15 mg
n=696 Participants
Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment \[creatinine clearance (CrCl): 30 to less than (\<) 50 milliliter per minute (mL/min)\]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
|
Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)
n=706 Participants
Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor \[prasugrel or ticagrelor\]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
|
Vitamin K Antagonist (VKA)
n=697 Participants
Participants received dose adjusted (to a target of international normalized ratio \[INR\] 2.0 to 3.0 \[or target INR 2.0 to 2.5\]) vitamin K antagonist (VKA) \[example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg \[or alternate P2Y12 inhibitor (prasugrel or ticagrelor)\] plus low-dose ASA \[75 to 100 mg\] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
|
|---|---|---|---|
|
Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Minor Bleeding
Up to Month 12 (n= 696, 706, 697)
|
1.0 percentage of participants
|
1.0 percentage of participants
|
1.9 percentage of participants
|
|
Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Minor Bleeding
End of DAPT-1 Month (n= 0, 108, 113)
|
NA percentage of participants
Analysis at end of DAPT-1 month conducted only in participants who received DAPT as part of therapy.
|
0.9 percentage of participants
|
1.8 percentage of participants
|
|
Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Minor Bleeding
End of DAPT-6 Month (n= 0, 248, 243)
|
NA percentage of participants
Analysis at end of DAPT-6 month conducted only in participants who received DAPT as part of therapy.
|
0.4 percentage of participants
|
2.5 percentage of participants
|
|
Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Minor Bleeding
End of DAPT-12 Month (n= 0, 350, 341)
|
NA percentage of participants
Analysis at end of DAPT-12 month conducted only in participants who received DAPT as part of therapy.
|
1.4 percentage of participants
|
1.5 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Month 12 and end of DAPT-Month 1, 6 and 12Population: The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'n' signifies number of participants analyzed at specific time-point in this outcome measure.
A BRMA event is defined as any bleeding event that requires medical treatment, surgical treatment, or laboratory evaluation, and does not meet criteria for a major or minor bleeding event.
Outcome measures
| Measure |
Rivaroxaban 15 mg
n=696 Participants
Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment \[creatinine clearance (CrCl): 30 to less than (\<) 50 milliliter per minute (mL/min)\]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
|
Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)
n=706 Participants
Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor \[prasugrel or ticagrelor\]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
|
Vitamin K Antagonist (VKA)
n=697 Participants
Participants received dose adjusted (to a target of international normalized ratio \[INR\] 2.0 to 3.0 \[or target INR 2.0 to 2.5\]) vitamin K antagonist (VKA) \[example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg \[or alternate P2Y12 inhibitor (prasugrel or ticagrelor)\] plus low-dose ASA \[75 to 100 mg\] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
|
|---|---|---|---|
|
Percentage of Participants With Bleeding Requiring Medical Attention (BRMA)
Up to Month 12 (n= 696, 706, 697)
|
13.4 percentage of participants
|
14.4 percentage of participants
|
19.9 percentage of participants
|
|
Percentage of Participants With Bleeding Requiring Medical Attention (BRMA)
End of DAPT-1 Month (n= 0, 108, 113)
|
NA percentage of participants
Analysis at end of DAPT-1 month conducted only in participants who received DAPT as part of therapy.
|
16.7 percentage of participants
|
18.6 percentage of participants
|
|
Percentage of Participants With Bleeding Requiring Medical Attention (BRMA)
End of DAPT-6 Month (n= 0, 248, 243)
|
NA percentage of participants
Analysis at end of DAPT-6 month conducted only in participants who received DAPT as part of therapy.
|
12.9 percentage of participants
|
23 percentage of participants
|
|
Percentage of Participants With Bleeding Requiring Medical Attention (BRMA)
End of DAPT-12 Month (n= 0, 350, 341)
|
NA percentage of participants
Analysis at end of DAPT-12 month conducted only in participants who received DAPT as part of therapy.
|
14.9 percentage of participants
|
18.2 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Month 12 and end of DAPT-Month 1, 6 and 12Population: The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure, 'n' signifies number of participants analyzed at specific time-point in this outcome measure.
Percentage of participants who experienced adverse cardiovascular events (cardiovascular death, myocardial Infarction (MI) and stroke) collectively, were assessed.
Outcome measures
| Measure |
Rivaroxaban 15 mg
n=694 Participants
Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment \[creatinine clearance (CrCl): 30 to less than (\<) 50 milliliter per minute (mL/min)\]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
|
Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)
n=704 Participants
Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor \[prasugrel or ticagrelor\]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
|
Vitamin K Antagonist (VKA)
n=695 Participants
Participants received dose adjusted (to a target of international normalized ratio \[INR\] 2.0 to 3.0 \[or target INR 2.0 to 2.5\]) vitamin K antagonist (VKA) \[example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg \[or alternate P2Y12 inhibitor (prasugrel or ticagrelor)\] plus low-dose ASA \[75 to 100 mg\] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
|
|---|---|---|---|
|
Percentage of Participants With Composite of Adverse Cardiovascular Events (Cardiovascular Death, Myocardial Infarction (MI) and Stroke)
Up to Month 12 (n= 694, 704, 695)
|
5.9 percentage of participants
|
5.1 percentage of participants
|
5.2 percentage of participants
|
|
Percentage of Participants With Composite of Adverse Cardiovascular Events (Cardiovascular Death, Myocardial Infarction (MI) and Stroke)
End of DAPT-1 Month (n= 0, 108, 112)
|
NA percentage of participants
Analysis at end of DAPT-1 month conducted only in participants who received DAPT as part of therapy.
|
5.6 percentage of participants
|
4.5 percentage of participants
|
|
Percentage of Participants With Composite of Adverse Cardiovascular Events (Cardiovascular Death, Myocardial Infarction (MI) and Stroke)
End of DAPT-6 Month (n= 0, 248, 243)
|
NA percentage of participants
Analysis at end of DAPT-6 month conducted only in participants who received DAPT as part of therapy.
|
6.5 percentage of participants
|
3.7 percentage of participants
|
|
Percentage of Participants With Composite of Adverse Cardiovascular Events (Cardiovascular Death, Myocardial Infarction (MI) and Stroke)
End of DAPT-12 Month (n= 0, 348, 340)
|
NA percentage of participants
Analysis at end of DAPT-12 month conducted only in participants who received DAPT as part of therapy.
|
4 percentage of participants
|
6.5 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Month 12 and end of DAPT-Month 1, 6 and 12Population: The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure, 'n' signifies number of participants analyzed at specific time-point in this outcome measure.
The percentage of participants with the first occurrence of cardiovascular death were evaluated.
Outcome measures
| Measure |
Rivaroxaban 15 mg
n=694 Participants
Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment \[creatinine clearance (CrCl): 30 to less than (\<) 50 milliliter per minute (mL/min)\]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
|
Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)
n=704 Participants
Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor \[prasugrel or ticagrelor\]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
|
Vitamin K Antagonist (VKA)
n=695 Participants
Participants received dose adjusted (to a target of international normalized ratio \[INR\] 2.0 to 3.0 \[or target INR 2.0 to 2.5\]) vitamin K antagonist (VKA) \[example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg \[or alternate P2Y12 inhibitor (prasugrel or ticagrelor)\] plus low-dose ASA \[75 to 100 mg\] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
|
|---|---|---|---|
|
Percentage of Participants With Cardiovascular Death
Up to Month 12 (n= 694, 704, 695)
|
2.2 percentage of participants
|
2 percentage of participants
|
1.6 percentage of participants
|
|
Percentage of Participants With Cardiovascular Death
End of DAPT-1 Month (n= 0, 108, 112)
|
NA percentage of participants
Analysis at end of DAPT-1 month conducted only in participants who received DAPT as part of therapy.
|
1.9 percentage of participants
|
1.8 percentage of participants
|
|
Percentage of Participants With Cardiovascular Death
End of DAPT-6 Month (n= 0, 248, 243)
|
NA percentage of participants
Analysis at end of DAPT-6 month conducted only in participants who received DAPT as part of therapy.
|
2.4 percentage of participants
|
1.6 percentage of participants
|
|
Percentage of Participants With Cardiovascular Death
End of DAPT-12 Month (n= 0, 348, 340)
|
NA percentage of participants
Analysis at end of DAPT-12 month conducted only in participants who received DAPT as part of therapy.
|
1.7 percentage of participants
|
1.5 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Month 12 and end of DAPT-Month 1, 6 and 12Population: The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure, 'n' signifies number of participants analyzed at specific time-point in this outcome measure.
The percentage of participants with the first occurrence of Myocardial Infarction were evaluated.
Outcome measures
| Measure |
Rivaroxaban 15 mg
n=694 Participants
Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment \[creatinine clearance (CrCl): 30 to less than (\<) 50 milliliter per minute (mL/min)\]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
|
Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)
n=704 Participants
Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor \[prasugrel or ticagrelor\]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
|
Vitamin K Antagonist (VKA)
n=695 Participants
Participants received dose adjusted (to a target of international normalized ratio \[INR\] 2.0 to 3.0 \[or target INR 2.0 to 2.5\]) vitamin K antagonist (VKA) \[example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg \[or alternate P2Y12 inhibitor (prasugrel or ticagrelor)\] plus low-dose ASA \[75 to 100 mg\] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
|
|---|---|---|---|
|
Percentage of Participants With Myocardial Infarction
Up to Month 12 (n= 694, 704, 695)
|
2.7 percentage of participants
|
2.4 percentage of participants
|
3 percentage of participants
|
|
Percentage of Participants With Myocardial Infarction
End of DAPT-1 Month (n= 0, 108, 112)
|
NA percentage of participants
Analysis at end of DAPT-1 month conducted only in participants who received DAPT as part of therapy.
|
2.8 percentage of participants
|
0.9 percentage of participants
|
|
Percentage of Participants With Myocardial Infarction
End of DAPT-6 Month (n= 0, 248, 243)
|
NA percentage of participants
Analysis at end of DAPT-6 month conducted only in participants who received DAPT as part of therapy.
|
2.8 percentage of participants
|
2.5 percentage of participants
|
|
Percentage of Participants With Myocardial Infarction
End of DAPT-12 Month (n= 0, 348, 340)
|
NA percentage of participants
Analysis at end of DAPT-12 month conducted only in participants who received DAPT as part of therapy.
|
2 percentage of participants
|
4.1 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Month 12 and end of DAPT-Month 1, 6 and 12Population: The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure, 'n' signifies number of participants analyzed at specific time-point in this outcome measure.
The percentage of participants with the first occurrence of Stroke were evaluated.
Outcome measures
| Measure |
Rivaroxaban 15 mg
n=694 Participants
Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment \[creatinine clearance (CrCl): 30 to less than (\<) 50 milliliter per minute (mL/min)\]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
|
Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)
n=704 Participants
Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor \[prasugrel or ticagrelor\]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
|
Vitamin K Antagonist (VKA)
n=695 Participants
Participants received dose adjusted (to a target of international normalized ratio \[INR\] 2.0 to 3.0 \[or target INR 2.0 to 2.5\]) vitamin K antagonist (VKA) \[example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg \[or alternate P2Y12 inhibitor (prasugrel or ticagrelor)\] plus low-dose ASA \[75 to 100 mg\] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
|
|---|---|---|---|
|
Percentage of Participants With Stroke
End of DAPT-6 Month (n= 0, 248, 243)
|
NA percentage of participants
Analysis at end of DAPT-6 month conducted only in participants who received DAPT as part of therapy.
|
2.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Stroke
End of DAPT-12 Month (n= 0, 348, 340)
|
NA percentage of participants
Analysis at end of DAPT-12 month conducted only in participants who received DAPT as part of therapy.
|
0.6 percentage of participants
|
1.2 percentage of participants
|
|
Percentage of Participants With Stroke
Up to Month 12 (n= 694, 704, 695)
|
1.2 percentage of participants
|
1.4 percentage of participants
|
1 percentage of participants
|
|
Percentage of Participants With Stroke
End of DAPT-1 Month (n= 0, 108, 112)
|
NA percentage of participants
Analysis at end of DAPT-1 month conducted only in participants who received DAPT as part of therapy.
|
1.9 percentage of participants
|
2.7 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Month 12 and end of DAPT-Month 1, 6 and 12Population: The safety analysis set is defined as all randomized participants who received at least 1 dose of study drug. Here 'N' signifies number of participants who were evaluable for this outcome measure, 'n' signifies number of participants analyzed at specific time-point in this outcome measure.
The percentage of participants with the first occurrence of stent thrombosis were evaluated.
Outcome measures
| Measure |
Rivaroxaban 15 mg
n=694 Participants
Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment \[creatinine clearance (CrCl): 30 to less than (\<) 50 milliliter per minute (mL/min)\]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
|
Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)
n=704 Participants
Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor \[prasugrel or ticagrelor\]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
|
Vitamin K Antagonist (VKA)
n=695 Participants
Participants received dose adjusted (to a target of international normalized ratio \[INR\] 2.0 to 3.0 \[or target INR 2.0 to 2.5\]) vitamin K antagonist (VKA) \[example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg \[or alternate P2Y12 inhibitor (prasugrel or ticagrelor)\] plus low-dose ASA \[75 to 100 mg\] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
|
|---|---|---|---|
|
Percentage of Participants With Stent Thrombosis
End of DAPT-12 Month (n= 0, 348, 340)
|
NA percentage of participants
Analysis at end of DAPT-12 month conducted only in participants who received DAPT as part of therapy.
|
0 percentage of participants
|
0.6 percentage of participants
|
|
Percentage of Participants With Stent Thrombosis
Up to Month 12 (n= 694, 704, 695)
|
0.7 percentage of participants
|
0.9 percentage of participants
|
0.6 percentage of participants
|
|
Percentage of Participants With Stent Thrombosis
End of DAPT-1 Month (n= 0, 108, 112)
|
NA percentage of participants
Analysis at end of DAPT-1 month conducted only in participants who received DAPT as part of therapy.
|
1.9 percentage of participants
|
0.9 percentage of participants
|
|
Percentage of Participants With Stent Thrombosis
End of DAPT-6 Month (n= 0, 248, 243)
|
NA percentage of participants
Analysis at end of DAPT-6 month conducted only in participants who received DAPT as part of therapy.
|
1.6 percentage of participants
|
0.4 percentage of participants
|
Adverse Events
Rivaroxaban 15 mg
Serious events: 237 serious events
Other events: 174 other events
Deaths: 0 deaths
Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)
Serious events: 225 serious events
Other events: 210 other events
Deaths: 0 deaths
Vitamin K Antagonist (VKA)
Serious events: 271 serious events
Other events: 234 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rivaroxaban 15 mg
n=696 participants at risk
Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment \[creatinine clearance (CrCl): 30 to less than (\<) 50 milliliter per minute (mL/min)\]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
|
Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)
n=706 participants at risk
Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor \[prasugrel or ticagrelor\]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
|
Vitamin K Antagonist (VKA)
n=697 participants at risk
Participants received dose adjusted (to a target of international normalized ratio \[INR\] 2.0 to 3.0 \[or target INR 2.0 to 2.5\]) vitamin K antagonist (VKA) \[example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg \[or alternate P2Y12 inhibitor (prasugrel or ticagrelor)\] plus low-dose ASA \[75 to 100 mg\] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
|
|---|---|---|---|
|
Cardiac disorders
Cardiac Disorder
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac Failure
|
3.0%
21/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
2.3%
16/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
4.4%
31/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac Failure Acute
|
0.43%
3/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.42%
3/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.57%
4/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac Failure Chronic
|
0.43%
3/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.43%
3/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
1.0%
7/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.57%
4/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
1.6%
11/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac Pseudoaneurysm
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiogenic Shock
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiomyopathy
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiovascular Disorder
|
0.29%
2/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.43%
3/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.71%
5/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.29%
2/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Coronary Artery Stenosis
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Coronary Artery Thrombosis
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Dressler's Syndrome
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Ischaemic Cardiomyopathy
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Left Ventricular Dysfunction
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Left Ventricular Failure
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.29%
2/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.29%
2/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.29%
2/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.29%
2/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.72%
5/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.57%
4/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.57%
4/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Haemorrhagic Anaemia
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Hypergammaglobulinaemia
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Hypochromic Anaemia
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Microcytic Anaemia
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.43%
3/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.72%
5/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.71%
5/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.43%
3/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Angina Pectoris
|
1.0%
7/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
1.8%
13/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
2.2%
15/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Angina Unstable
|
2.3%
16/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
1.7%
12/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
3.3%
23/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial Fibrillation
|
1.9%
13/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
3.0%
21/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
3.3%
23/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.71%
5/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.57%
4/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial Tachycardia
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.28%
2/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial Thrombosis
|
0.57%
4/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrioventricular Block
|
0.29%
2/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrioventricular Block Complete
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Bradyarrhythmia
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Bradycardia
|
0.29%
2/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.29%
2/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.28%
2/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.29%
2/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Pericardial Haemorrhage
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Sinus Bradycardia
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Sinus Node Dysfunction
|
0.57%
4/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.29%
2/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.28%
2/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Tachycardia Induced Cardiomyopathy
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Ventricular Arrhythmia
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.29%
2/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.43%
3/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Deafness Neurosensory
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Eye disorders
Age-Related Macular Degeneration
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Eye disorders
Cataract
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.43%
3/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Eye disorders
Eye Haemorrhage
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Eye disorders
Vitreous Haemorrhage
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.43%
3/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Acute Abdomen
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Anal Fistula
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Anal Haemorrhage
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.29%
2/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Barrett's Oesophagus
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Change of Bowel Habit
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Colitis Microscopic
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Crohn's Disease
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.29%
2/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastric Haemorrhage
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastric Mucosa Erythema
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.42%
3/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.43%
3/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastric Ulcer Haemorrhage
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.29%
2/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.29%
2/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastritis Erosive
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.28%
2/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.29%
2/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastritis Haemorrhagic
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastroduodenitis Haemorrhagic
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
1.0%
7/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.99%
7/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
1.3%
9/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal Ulcer
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haematemesis
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haematochezia
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoidal Haemorrhage
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Impaired Gastric Emptying
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.43%
3/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intestinal Haemorrhage
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intestinal Ischaemia
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intra-Abdominal Haematoma
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Mallory-Weiss Syndrome
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.57%
4/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Mouth Haemorrhage
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.29%
2/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis Chronic
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.57%
4/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.28%
2/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Tongue Haemorrhage
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.29%
2/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.29%
2/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Catheter Site Swelling
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Chest Discomfort
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Chest Pain
|
1.1%
8/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.57%
4/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
1.3%
9/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Death
|
0.29%
2/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.28%
2/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Device Failure
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Drug Intolerance
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Drug Resistance
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Drug Withdrawal Syndrome
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Gait Disturbance
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Malaise
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Medical Device Complication
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Multi-Organ Failure
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.43%
3/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema Peripheral
|
0.29%
2/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Sudden Cardiac Death
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Sudden Death
|
0.29%
2/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.43%
3/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Ulcer Haemorrhage
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Vascular Stent Occlusion
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Vascular Stent Restenosis
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Vascular Stent Thrombosis
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.28%
2/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Vessel Puncture Site Haematoma
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholangitis
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.29%
2/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis Chronic
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.43%
3/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatic Cyst
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatitis Acute
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatitis Toxic
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatocellular Injury
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Jaundice
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Anaphylactic Shock
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Abdominal Wall Abscess
|
0.29%
2/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Abscess Limb
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Arthritis Bacterial
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.28%
2/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bacterial Sepsis
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.43%
3/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis Bacterial
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.29%
2/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cystitis
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Diverticulitis
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Encephalitis Viral
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gangrene
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.28%
2/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.29%
2/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastrointestinal Infection
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Haematoma Infection
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Infected Skin Ulcer
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Infective Exacerbation of Chronic Obstructive Airways Disease
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Intervertebral Discitis
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Liver Abscess
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Localised Infection
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
1.7%
12/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
1.7%
12/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
2.0%
14/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pyelonephritis
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.29%
2/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Scrotal Abscess
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Septic Shock
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary Tract Infection
|
0.29%
2/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.28%
2/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.43%
3/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Compression Fracture
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Coronary Artery Restenosis
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Craniocerebral Injury
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.28%
2/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.29%
2/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.29%
2/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Incisional Hernia
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Muscle Rupture
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.72%
5/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.85%
6/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
1.0%
7/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Pneumothorax Traumatic
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Post Procedural Complication
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Post Procedural Haematoma
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.29%
2/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Pubis Fracture
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.29%
2/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Subdural Haemorrhage
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Toxicity to Various Agents
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Traumatic Fracture
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Traumatic Haematoma
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Biopsy Prostate
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Cardiac Stress Test
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Ejection Fraction Decreased
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Electrocardiogram Ambulatory Abnormal
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Haemoglobin Decreased
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Hepatic Enzyme Increased
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.28%
2/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
International Normalised Ratio Increased
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.57%
4/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Lipids Increased
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.29%
2/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetic Metabolic Decompensation
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.29%
2/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Metabolic Disorder
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.28%
2/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Gouty Arthritis
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint Effusion
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Disorder
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.43%
3/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rheumatic Disorder
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal Column Stenosis
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal Disorder
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal Osteoarthritis
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal Pain
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal Neoplasm
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ameloblastoma
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer Recurrent
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Neoplasm
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's Disease
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Neoplasm Malignant
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Stage I
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial Carcinoma
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Neoplasm
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal Adenocarcinoma
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse Large B-Cell Lymphoma
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder Cancer Metastatic
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal Stromal Tumour
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular Carcinoma
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.28%
2/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to Liver
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary Tumour Benign
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer
|
0.29%
2/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Neoplasm
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Neoplasm
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small Cell Lung Cancer Metastatic
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Aphasia
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.28%
2/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.57%
4/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebral Infarction
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebral Ischaemia
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.29%
2/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.57%
4/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness Postural
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Haemorrhagic Stroke
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Hemianopia
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Intercostal Neuralgia
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Intracranial Haematoma
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Ischaemic Stroke
|
0.72%
5/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.28%
2/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.57%
4/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Lacunar Infarction
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Parkinson's Disease
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Presyncope
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Sciatica
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.57%
4/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
1.1%
8/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Tension Headache
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.43%
3/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Viith Nerve Paralysis
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety Disorder
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Confusional State
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Delirium
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Hallucination
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.29%
2/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.28%
2/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Bladder Tamponade
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Calculus Ureteric
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Calculus Urethral
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Calculus Urinary
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.72%
5/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.42%
3/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.57%
4/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Haemorrhage Urinary Tract
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Prerenal Failure
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal Artery Stenosis
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal Failure
|
0.29%
2/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal Impairment
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urethral Haemorrhage
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urethral Stenosis
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.28%
2/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Cervical Polyp
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
0.29%
2/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis Chronic
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.29%
2/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.28%
2/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.43%
3/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.86%
6/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.85%
6/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
1.4%
10/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.43%
3/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at Rest
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.72%
5/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.71%
5/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.72%
5/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.29%
2/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.28%
2/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.57%
4/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Lung Disorder
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Congestion
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.28%
2/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Mass
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.29%
2/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.29%
2/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnoea Syndrome
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.28%
2/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Diabetic Foot
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin Necrosis
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Surgical and medical procedures
Angioplasty
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Surgical and medical procedures
Aortic Valve Replacement
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Surgical and medical procedures
Cardiac Ablation
|
0.29%
2/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Surgical and medical procedures
Cardiac Pacemaker Insertion
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Surgical and medical procedures
Cardiac Resynchronisation Therapy
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Surgical and medical procedures
Cardioversion
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.28%
2/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.29%
2/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Surgical and medical procedures
Coronary Arterial Stent Insertion
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Surgical and medical procedures
Coronary Artery Bypass
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Surgical and medical procedures
Hospitalisation
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Surgical and medical procedures
Ileostomy Closure
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Surgical and medical procedures
Implantable Defibrillator Insertion
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.28%
2/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Surgical and medical procedures
Knee Arthroplasty
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.28%
2/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Surgical and medical procedures
Mitral Valve Repair
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Surgical and medical procedures
Percutaneous Coronary Intervention
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Surgical and medical procedures
Renal Sympathetic Nerve Ablation
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Surgical and medical procedures
Tooth Extraction
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Aortic Aneurysm
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Aortic Stenosis
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Arterial Stenosis
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.28%
2/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Arteriovenous Fistula
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Circulatory Collapse
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Extremity Necrosis
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Femoral Artery Occlusion
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.29%
2/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Haematoma
|
0.29%
2/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.43%
3/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.43%
3/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.28%
2/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.29%
2/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertensive Crisis
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.42%
3/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.29%
2/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Intermittent Claudication
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.28%
2/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Lymphocele
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Malignant Hypertension
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.57%
4/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.29%
2/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Peripheral Artery Thrombosis
|
0.29%
2/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Peripheral Embolism
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Peripheral Ischaemia
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.28%
2/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Peripheral Vascular Disorder
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Shock Haemorrhagic
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Venous Occlusion
|
0.14%
1/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Venous Thrombosis
|
0.00%
0/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.14%
1/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Rivaroxaban 15 mg
n=696 participants at risk
Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment \[creatinine clearance (CrCl): 30 to less than (\<) 50 milliliter per minute (mL/min)\]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
|
Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)
n=706 participants at risk
Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor \[prasugrel or ticagrelor\]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
|
Vitamin K Antagonist (VKA)
n=697 participants at risk
Participants received dose adjusted (to a target of international normalized ratio \[INR\] 2.0 to 3.0 \[or target INR 2.0 to 2.5\]) vitamin K antagonist (VKA) \[example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg \[or alternate P2Y12 inhibitor (prasugrel or ticagrelor)\] plus low-dose ASA \[75 to 100 mg\] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
|
|---|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
1.9%
13/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
18/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
1.7%
12/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
12/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
18/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
1.6%
11/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gingival Bleeding
|
2.4%
17/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
2.3%
16/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
2.6%
18/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema Peripheral
|
2.0%
14/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
1.7%
12/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
2.6%
18/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.9%
13/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
35/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
3.6%
25/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Subcutaneous Haematoma
|
0.29%
2/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
1.4%
10/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
2.0%
14/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
1.1%
8/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.99%
7/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
2.2%
15/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
2.6%
18/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
2.0%
14/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
2.0%
14/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.9%
27/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
3.0%
21/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
2.6%
18/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.6%
67/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
8.4%
59/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
11.8%
82/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.57%
4/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
2.3%
16/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
2.2%
15/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Haematoma
|
3.0%
21/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
4.4%
31/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
8.8%
61/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
2.4%
17/696 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
0.28%
2/706 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
1.0%
7/697 • Upto 12 months
The Safety Analysis Set is defined as all randomized participants who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER