Trial Outcomes & Findings for Rivaroxaban in Combination With Aspirin Alone or With Aspirin and a Thienopyridine in Patients With Acute Coronary Syndromes (The ATLAS ACS TIMI 46 Trial) (NCT NCT00402597)
NCT ID: NCT00402597
Last Updated: 2012-10-04
Results Overview
The number of patients with a first occurrence of a TIMI clinically significant bleeding event that occurred from the time of randomization to the time of the last patient contact. TIMI clinically significant bleeding events included TIMI minor bleeding events, TIMI major bleeding events, or any bleeding that required medical attention.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
3490 participants
Primary outcome timeframe
Day 1 to Day 210
Results posted on
2012-10-04
Participant Flow
NCT00402597: Study 39039039ACS2001 (ATLAS ACS TIMI 46 Trial) was conducted at 297 centers in 27 countries between 17 November 2006 and 19 September 2008. A total of 3576 patients were screened for study and 3491 patients were randomly assigned to treatment.
Of the 3576 patients screened for study, 85 patients were screening failures and 3491 patients were randomly assigned to treatment. All randomized patients were included in the intent-to-treat (ITT) analysis set and were eligible for efficacy analyses. Of the 3491 patients, 29 never took study drug, leaving 3462 patients valid for safety analysis.
Participant milestones
| Measure |
Placebo
One placebo tablet twice daily for 6 months.
|
Riva 5 mg Total Daily Dose (TDD)
Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily)
|
Riva 10 mg TDD
Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
|
Riva 15 mg TDD
Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
|
Riva 20 mg TDD
Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1153
|
307
|
1046
|
353
|
603
|
|
Overall Study
COMPLETED
|
962
|
261
|
834
|
279
|
479
|
|
Overall Study
NOT COMPLETED
|
191
|
46
|
212
|
74
|
124
|
Reasons for withdrawal
| Measure |
Placebo
One placebo tablet twice daily for 6 months.
|
Riva 5 mg Total Daily Dose (TDD)
Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily)
|
Riva 10 mg TDD
Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
|
Riva 15 mg TDD
Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
|
Riva 20 mg TDD
Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
|
|---|---|---|---|---|---|
|
Overall Study
Death
|
15
|
7
|
6
|
4
|
6
|
|
Overall Study
Adverse Event
|
81
|
18
|
106
|
39
|
71
|
|
Overall Study
Lost to Follow-up
|
8
|
1
|
8
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
57
|
16
|
65
|
15
|
24
|
|
Overall Study
reason not specified
|
30
|
4
|
27
|
14
|
20
|
Baseline Characteristics
Rivaroxaban in Combination With Aspirin Alone or With Aspirin and a Thienopyridine in Patients With Acute Coronary Syndromes (The ATLAS ACS TIMI 46 Trial)
Baseline characteristics by cohort
| Measure |
Placebo
n=1153 Participants
One placebo tablet twice daily for 6 months.
|
Riva 5 mg Total Daily Dose (TDD)
n=307 Participants
Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily)
|
Riva 10 mg TDD
n=1046 Participants
Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
|
Riva 15 mg TDD
n=353 Participants
Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
|
Riva 20 mg TDD
n=603 Participants
Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
|
Total
n=3462 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
847 Participants
n=5 Participants
|
218 Participants
n=7 Participants
|
786 Participants
n=5 Participants
|
283 Participants
n=4 Participants
|
458 Participants
n=21 Participants
|
2592 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
306 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
260 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
145 Participants
n=21 Participants
|
870 Participants
n=8 Participants
|
|
Age Continuous
|
57.8 years
STANDARD_DEVIATION 9.58 • n=5 Participants
|
58.1 years
STANDARD_DEVIATION 9.76 • n=7 Participants
|
57.2 years
STANDARD_DEVIATION 9.71 • n=5 Participants
|
56.4 years
STANDARD_DEVIATION 9.38 • n=4 Participants
|
57.4 years
STANDARD_DEVIATION 9.06 • n=21 Participants
|
57.4 years
STANDARD_DEVIATION 9.53 • n=8 Participants
|
|
Sex: Female, Male
Female
|
272 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
228 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
143 Participants
n=21 Participants
|
788 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
881 Participants
n=5 Participants
|
229 Participants
n=7 Participants
|
818 Participants
n=5 Participants
|
286 Participants
n=4 Participants
|
460 Participants
n=21 Participants
|
2674 Participants
n=8 Participants
|
|
Region of Enrollment
Australia
|
75 participants
n=5 Participants
|
14 participants
n=7 Participants
|
73 participants
n=5 Participants
|
15 participants
n=4 Participants
|
29 participants
n=21 Participants
|
206 participants
n=8 Participants
|
|
Region of Enrollment
Belgium
|
19 participants
n=5 Participants
|
3 participants
n=7 Participants
|
34 participants
n=5 Participants
|
9 participants
n=4 Participants
|
12 participants
n=21 Participants
|
77 participants
n=8 Participants
|
|
Region of Enrollment
Brazil
|
11 participants
n=5 Participants
|
0 participants
n=7 Participants
|
26 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
37 participants
n=8 Participants
|
|
Region of Enrollment
Bulgaria
|
78 participants
n=5 Participants
|
47 participants
n=7 Participants
|
85 participants
n=5 Participants
|
7 participants
n=4 Participants
|
41 participants
n=21 Participants
|
258 participants
n=8 Participants
|
|
Region of Enrollment
Canada
|
34 participants
n=5 Participants
|
2 participants
n=7 Participants
|
28 participants
n=5 Participants
|
7 participants
n=4 Participants
|
17 participants
n=21 Participants
|
88 participants
n=8 Participants
|
|
Region of Enrollment
China
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
4 participants
n=8 Participants
|
|
Region of Enrollment
Czech Republic
|
48 participants
n=5 Participants
|
0 participants
n=7 Participants
|
58 participants
n=5 Participants
|
33 participants
n=4 Participants
|
41 participants
n=21 Participants
|
180 participants
n=8 Participants
|
|
Region of Enrollment
Denmark
|
18 participants
n=5 Participants
|
16 participants
n=7 Participants
|
14 participants
n=5 Participants
|
7 participants
n=4 Participants
|
9 participants
n=21 Participants
|
64 participants
n=8 Participants
|
|
Region of Enrollment
Finland
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
7 participants
n=5 Participants
|
0 participants
n=4 Participants
|
6 participants
n=21 Participants
|
16 participants
n=8 Participants
|
|
Region of Enrollment
France
|
16 participants
n=5 Participants
|
1 participants
n=7 Participants
|
21 participants
n=5 Participants
|
5 participants
n=4 Participants
|
6 participants
n=21 Participants
|
49 participants
n=8 Participants
|
|
Region of Enrollment
Germany
|
31 participants
n=5 Participants
|
3 participants
n=7 Participants
|
35 participants
n=5 Participants
|
11 participants
n=4 Participants
|
12 participants
n=21 Participants
|
92 participants
n=8 Participants
|
|
Region of Enrollment
Hungary
|
11 participants
n=5 Participants
|
0 participants
n=7 Participants
|
14 participants
n=5 Participants
|
7 participants
n=4 Participants
|
4 participants
n=21 Participants
|
36 participants
n=8 Participants
|
|
Region of Enrollment
Israel
|
43 participants
n=5 Participants
|
0 participants
n=7 Participants
|
26 participants
n=5 Participants
|
16 participants
n=4 Participants
|
11 participants
n=21 Participants
|
96 participants
n=8 Participants
|
|
Region of Enrollment
Italy
|
43 participants
n=5 Participants
|
3 participants
n=7 Participants
|
56 participants
n=5 Participants
|
17 participants
n=4 Participants
|
17 participants
n=21 Participants
|
136 participants
n=8 Participants
|
|
Region of Enrollment
Korea (South)
|
17 participants
n=5 Participants
|
0 participants
n=7 Participants
|
9 participants
n=5 Participants
|
10 participants
n=4 Participants
|
11 participants
n=21 Participants
|
47 participants
n=8 Participants
|
|
Region of Enrollment
Netherlands
|
28 participants
n=5 Participants
|
0 participants
n=7 Participants
|
39 participants
n=5 Participants
|
9 participants
n=4 Participants
|
11 participants
n=21 Participants
|
87 participants
n=8 Participants
|
|
Region of Enrollment
New Zealand
|
57 participants
n=5 Participants
|
22 participants
n=7 Participants
|
37 participants
n=5 Participants
|
8 participants
n=4 Participants
|
24 participants
n=21 Participants
|
148 participants
n=8 Participants
|
|
Region of Enrollment
Norway
|
8 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
0 participants
n=4 Participants
|
5 participants
n=21 Participants
|
21 participants
n=8 Participants
|
|
Region of Enrollment
Poland
|
174 participants
n=5 Participants
|
4 participants
n=7 Participants
|
109 participants
n=5 Participants
|
86 participants
n=4 Participants
|
124 participants
n=21 Participants
|
497 participants
n=8 Participants
|
|
Region of Enrollment
Russia
|
136 participants
n=5 Participants
|
90 participants
n=7 Participants
|
105 participants
n=5 Participants
|
17 participants
n=4 Participants
|
82 participants
n=21 Participants
|
430 participants
n=8 Participants
|
|
Region of Enrollment
Slovakia
|
49 participants
n=5 Participants
|
1 participants
n=7 Participants
|
32 participants
n=5 Participants
|
13 participants
n=4 Participants
|
21 participants
n=21 Participants
|
116 participants
n=8 Participants
|
|
Region of Enrollment
South Africa
|
6 participants
n=5 Participants
|
0 participants
n=7 Participants
|
7 participants
n=5 Participants
|
0 participants
n=4 Participants
|
4 participants
n=21 Participants
|
17 participants
n=8 Participants
|
|
Region of Enrollment
Spain
|
35 participants
n=5 Participants
|
5 participants
n=7 Participants
|
36 participants
n=5 Participants
|
12 participants
n=4 Participants
|
15 participants
n=21 Participants
|
103 participants
n=8 Participants
|
|
Region of Enrollment
Sweden
|
13 participants
n=5 Participants
|
2 participants
n=7 Participants
|
17 participants
n=5 Participants
|
6 participants
n=4 Participants
|
9 participants
n=21 Participants
|
47 participants
n=8 Participants
|
|
Region of Enrollment
Ukraine
|
57 participants
n=5 Participants
|
21 participants
n=7 Participants
|
37 participants
n=5 Participants
|
11 participants
n=4 Participants
|
33 participants
n=21 Participants
|
159 participants
n=8 Participants
|
|
Region of Enrollment
United Kingdom
|
9 participants
n=5 Participants
|
1 participants
n=7 Participants
|
19 participants
n=5 Participants
|
15 participants
n=4 Participants
|
8 participants
n=21 Participants
|
52 participants
n=8 Participants
|
|
Region of Enrollment
United States
|
132 participants
n=5 Participants
|
69 participants
n=7 Participants
|
115 participants
n=5 Participants
|
32 participants
n=4 Participants
|
51 participants
n=21 Participants
|
399 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 210Population: The safety population consisted of all randomized patients who took at least 1 dose of study medication after randomization during the double-blind treatment period.
The number of patients with a first occurrence of a TIMI clinically significant bleeding event that occurred from the time of randomization to the time of the last patient contact. TIMI clinically significant bleeding events included TIMI minor bleeding events, TIMI major bleeding events, or any bleeding that required medical attention.
Outcome measures
| Measure |
Placebo
n=1153 Participants
One Placebo tablet twice daily for 6 months.
|
Riva 5 mg Total Daily Dose (TDD)
n=307 Participants
Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
|
Riva 10 mg TDD
n=1046 Participants
Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
|
Riva 15 mg TDD
n=353 Participants
Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
|
Riva 20 mg TDD
n=603 Participants
Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
|
|---|---|---|---|---|---|
|
Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events (Primary Safety)
|
36 Patients
|
17 Patients
|
109 Patients
|
43 Patients
|
89 Patients
|
PRIMARY outcome
Timeframe: Day 1 to Day 210Population: The intent-to-treat (ITT) population consisted of all patients who were randomized to treatment, regardless of study drug intake.
The number of patients who died due to any cause or had a first occurrence of MI (including repeat MI) or stroke (ischemic, hemorrhagic or unknown) or severe recurrent ischemia requiring revascularization from the time of randomization to the last date of patient contact.
Outcome measures
| Measure |
Placebo
n=1160 Participants
One Placebo tablet twice daily for 6 months.
|
Riva 5 mg Total Daily Dose (TDD)
n=308 Participants
Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
|
Riva 10 mg TDD
n=1056 Participants
Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
|
Riva 15 mg TDD
n=356 Participants
Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
|
Riva 20 mg TDD
n=611 Participants
Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
|
|---|---|---|---|---|---|
|
The Composite Endpoint of All Cause Death, Myocardial Infarction (MI) (Including Repeat MI), Stroke (Ischemic, Hemorrhagic or Unknown), or Severe Recurrent Ischemia Requiring Revascularization (Primary Efficacy)
|
83 Patients
|
23 Patients
|
55 Patients
|
27 Patients
|
36 Patients
|
SECONDARY outcome
Timeframe: Day 1 to Day 210Population: The ITT population consisted of all patients who were randomized to treatment, regardliess of study drug intake.
The number of patients who died due to any cause or had a first occurrence of MI (or repeat MI) or stroke from the time of randomization to the last date of patient contact.
Outcome measures
| Measure |
Placebo
n=1160 Participants
One Placebo tablet twice daily for 6 months.
|
Riva 5 mg Total Daily Dose (TDD)
n=308 Participants
Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
|
Riva 10 mg TDD
n=1056 Participants
Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
|
Riva 15 mg TDD
n=356 Participants
Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
|
Riva 20 mg TDD
n=611 Participants
Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
|
|---|---|---|---|---|---|
|
The Composite Endpoint of Death (All Cause), Myocardial Infarction (MI) (or Repeat MI), or Stroke
|
66 Patients
|
18 Patients
|
40 Patients
|
21 Patients
|
22 Patients
|
SECONDARY outcome
Timeframe: Day 1 to Day 210Population: The ITT population consisted of all patients who were randomized to treatment regardless of study drug intake.
The number of patients with the composite endpoint of cardiovascular death or MI or stroke that occurred from the time of randomization to the last date of patient contact.
Outcome measures
| Measure |
Placebo
n=1160 Participants
One Placebo tablet twice daily for 6 months.
|
Riva 5 mg Total Daily Dose (TDD)
n=308 Participants
Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
|
Riva 10 mg TDD
n=1056 Participants
Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
|
Riva 15 mg TDD
n=356 Participants
Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
|
Riva 20 mg TDD
n=611 Participants
Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
|
|---|---|---|---|---|---|
|
The Composite Endpoint of Cardiovascular Death, Myocardial Infarction (MI), or Stroke
|
63 Patients
|
18 Patients
|
40 Patients
|
21 Patients
|
21 Patients
|
SECONDARY outcome
Timeframe: Day 1 to Day 210Population: The ITT population consisted of all patients who were randomized to treatment, regardless of study drug intake.
The number of patients who died due to any cause from the time of randomization to the last date of patient contact.
Outcome measures
| Measure |
Placebo
n=1160 Participants
One Placebo tablet twice daily for 6 months.
|
Riva 5 mg Total Daily Dose (TDD)
n=308 Participants
Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
|
Riva 10 mg TDD
n=1056 Participants
Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
|
Riva 15 mg TDD
n=356 Participants
Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
|
Riva 20 mg TDD
n=611 Participants
Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
|
|---|---|---|---|---|---|
|
The Number of Deaths (All Cause)
|
18 Patients
|
11 Patients
|
9 Patients
|
4 Patients
|
9 Patients
|
SECONDARY outcome
Timeframe: Day 1 to Day 210Population: The ITT population consisted of all patients who were randomized to treatment, regardless of study drug intake.
The number of patients who died due to any cause or had a first occurrence of MI (or repeat MI), or stroke, or severe recurrent ischemia requiring revascularization, or TIMI (major or minor bleeding) from the time of randomization to the last date of patient contact to assess the net clinical benefit of rivaroxaban.
Outcome measures
| Measure |
Placebo
n=1160 Participants
One Placebo tablet twice daily for 6 months.
|
Riva 5 mg Total Daily Dose (TDD)
n=308 Participants
Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
|
Riva 10 mg TDD
n=1056 Participants
Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
|
Riva 15 mg TDD
n=356 Participants
Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
|
Riva 20 mg TDD
n=611 Participants
Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
|
|---|---|---|---|---|---|
|
The Composite Endpoint of Death (All Cause), MI (or reMI), Stroke, Severe Recurrent Ischemia Requiring Revascularization, or Thrombolysis in Myocardial Infarction (TIMI) (Major or Minor Bleeding) to Assess the Net Clinical Benefit
|
88 Patients
|
24 Patients
|
71 Patients
|
35 Patients
|
48 Patients
|
Adverse Events
Placebo
Serious events: 247 serious events
Other events: 223 other events
Deaths: 0 deaths
Riva 5 mg Total Daily Dose (TDD)
Serious events: 74 serious events
Other events: 67 other events
Deaths: 0 deaths
Riva 10 mg TDD
Serious events: 208 serious events
Other events: 293 other events
Deaths: 0 deaths
Riva 15 mg TDD
Serious events: 72 serious events
Other events: 108 other events
Deaths: 0 deaths
Riva 20 mg TDD
Serious events: 128 serious events
Other events: 148 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=1153 participants at risk
One placebo tablet twice daily for 6 months.
|
Riva 5 mg Total Daily Dose (TDD)
n=307 participants at risk
Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
|
Riva 10 mg TDD
n=1046 participants at risk
Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
|
Riva 15 mg TDD
n=353 participants at risk
Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
|
Riva 20 mg TDD
n=603 participants at risk
Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
|
|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.50%
3/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Blood and lymphatic system disorders
Anaemia
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.29%
3/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Blood and lymphatic system disorders
Haemorrhagic Anaemia
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Blood and lymphatic system disorders
Normochromic Normocytic Anaemia
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Blood and lymphatic system disorders
Thrombocythaemia
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.26%
3/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
2/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Acute Myocardial Infarction
|
2.4%
28/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
2.0%
6/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
1.2%
13/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
2.3%
8/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.83%
5/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Angina Pectoris
|
1.9%
22/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
1.3%
4/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
1.5%
16/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
1.1%
4/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
1.7%
10/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Angina Unstable
|
3.6%
42/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
3.9%
12/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
2.2%
23/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
3.1%
11/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
3.5%
21/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Arteriosclerosis Coronary Artery
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Arteriospasm Coronary
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Atrial Fibrillation
|
0.61%
7/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
1.6%
5/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.57%
6/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.57%
2/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Atrial Flutter
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.29%
3/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Atrioventricular Block Second Degree
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.19%
2/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Cardiac Arrest
|
0.17%
2/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.50%
3/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Cardiac Failure
|
0.52%
6/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.57%
6/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Cardiac Failure Acute
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.98%
3/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.85%
3/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Cardiogenic Shock
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Coronary Artery Disease
|
0.43%
5/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.29%
3/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Coronary Artery Insufficiency
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Coronary Artery Occlusion
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Coronary Artery Stenosis
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.57%
2/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Dressler's Syndrome
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Intracardiac Thrombus
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Left Ventricular Dysfunction
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Left Ventricular Failure
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Myocardial Infarction
|
0.43%
5/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.98%
3/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.57%
6/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.85%
3/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
1.3%
8/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.52%
6/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
1.1%
12/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
2/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Palpitations
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.29%
3/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Parasystole
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Pericardial Effusion
|
0.17%
2/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Pericarditis
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Postinfarction Angina
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Sick Sinus Syndrome
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Sinus Bradycardia
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Ventricular Arrhythmia
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Ventricular Dysfunction
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.19%
2/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Congenital, familial and genetic disorders
Endocardial Fibroelastosis
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Endocrine disorders
Thyroid Disorder
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Eye disorders
Conjunctival Haemorrhage
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Eye disorders
Eye Haemorrhage
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Eye disorders
Retinal Artery Thrombosis
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Eye disorders
Vitreous Haemorrhage
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Gastrointestinal disorders
Anal Fissure
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Gastrointestinal disorders
Colitis Ischaemic
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Gastrointestinal disorders
Gastric Ulcer Haemorrhage
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.17%
2/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.96%
10/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.85%
3/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
1.00%
6/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Gastrointestinal disorders
Gingival Bleeding
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Gastrointestinal disorders
Haematemesis
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Gastrointestinal disorders
Haemorrhoidal Haemorrhage
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Gastrointestinal disorders
Intestinal Haemorrhage
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.85%
3/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Gastrointestinal disorders
Oesophageal Haemorrhage
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Gastrointestinal disorders
Pancreatitis
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Gastrointestinal disorders
Peptic Ulcer
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Gastrointestinal disorders
Peptic Ulcer Haemorrhage
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Gastrointestinal disorders
Retroperitoneal Haematoma
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Gastrointestinal disorders
Small Intestinal Haemorrhage
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
General disorders
Asthenia
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.50%
3/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
General disorders
Catheter Site Haemorrhage
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
General disorders
Chest Discomfort
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.19%
2/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
2/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
General disorders
Chest Pain
|
2.1%
24/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
2.9%
9/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
1.6%
17/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.57%
2/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
1.5%
9/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
General disorders
Death
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
General disorders
Injection Site Phlebitis
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
General disorders
Non-Cardiac Chest Pain
|
0.95%
11/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
1.3%
4/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
1.2%
13/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.57%
2/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.83%
5/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
General disorders
Puncture Site Haemorrhage
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.19%
2/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
General disorders
Puncture Site Reaction
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
General disorders
Pyrexia
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
General disorders
Sudden Cardiac Death
|
0.26%
3/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
General disorders
Sudden Death
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.19%
2/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
General disorders
Vessel Puncture Site Haemorrhage
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Hepatobiliary disorders
Cholecystitis
|
0.17%
2/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
2/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Immune system disorders
Anaphylactic Shock
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Infections and infestations
Abscess Limb
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Infections and infestations
Anal Abscess
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Infections and infestations
Bronchitis
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Infections and infestations
Bronchopneumonia
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
2/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Infections and infestations
Cellulitis
|
0.17%
2/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Infections and infestations
Cellulitis Orbital
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Infections and infestations
Cellulitis Pharyngeal
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Infections and infestations
Device Related Infection
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Infections and infestations
Erysipelas
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Infections and infestations
Gangrene
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Infections and infestations
Gastroenteritis
|
0.17%
2/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.19%
2/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Infections and infestations
Gastrointestinal Infection
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Infections and infestations
Gingival Abscess
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Infections and infestations
Implant Site Infection
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Infections and infestations
Lobar Pneumonia
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Infections and infestations
Orchitis
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Infections and infestations
Pneumonia
|
0.26%
3/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.85%
3/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Infections and infestations
Post Procedural Infection
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Infections and infestations
Sepsis
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Infections and infestations
Staphylococcal Sepsis
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Infections and infestations
Viral Infection
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Infections and infestations
Wound Infection
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Coronary Artery Restenosis
|
0.17%
2/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
2/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Implantable Defibrillator Malfunction
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Injury, poisoning and procedural complications
In-Stent Coronary Artery Restenosis
|
0.35%
4/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Multiple Injuries
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Post Procedural Haematoma
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Skull Fracture
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.29%
3/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Thrombosis in Device
|
0.26%
3/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Traumatic Haematoma
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.48%
5/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm Ruptured
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Investigations
Alanine Aminotransferase Increased
|
0.17%
2/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.65%
2/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Investigations
Angiogram
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Investigations
Arteriogram Coronary
|
0.52%
6/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.29%
3/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.66%
4/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.65%
2/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Investigations
Blood Bilirubin Increased
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Investigations
C-Reactive Protein Increased
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Investigations
Chest X-Ray Abnormal
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Investigations
Ejection Fraction Decreased
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Investigations
Haemoglobin Decreased
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.57%
2/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Investigations
Hepatic Enzyme Increased
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Investigations
Liver Function Test Abnormal
|
0.17%
2/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Investigations
Occult Blood
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Metabolism and nutrition disorders
Dehydration
|
0.17%
2/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.57%
2/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.17%
2/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Arthritis Reactive
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Back Disorder
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Musculoskeletal and connective tissue disorders
Spondyloarthropathy
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer in Situ
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Neoplasm
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic Syndrome
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Granulosa-Theca Cell Tumour
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Neoplasm
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Nervous system disorders
Brain Oedema
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Nervous system disorders
Carpal Tunnel Syndrome
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Nervous system disorders
Cerebral Infarction
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Nervous system disorders
Haemorrhage Intracranial
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Nervous system disorders
Haemorrhagic Stroke
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Nervous system disorders
Headache
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Nervous system disorders
Ischaemic Cerebral Infarction
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Nervous system disorders
Ischaemic Stroke
|
0.17%
2/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Nervous system disorders
Lethargy
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Nervous system disorders
Motor Neurone Disease
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Nervous system disorders
Presyncope
|
0.17%
2/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Nervous system disorders
Progressive Supranuclear Palsy
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Nervous system disorders
Somnolence
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Nervous system disorders
Subarachnoid Haemorrhage
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Nervous system disorders
Syncope
|
0.17%
2/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.19%
2/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Nervous system disorders
Vascular Encephalopathy
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Nervous system disorders
Vertebrobasilar Insufficiency
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Psychiatric disorders
Acute Psychosis
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Psychiatric disorders
Alcohol Withdrawal Syndrome
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.57%
2/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Psychiatric disorders
Depression
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Psychiatric disorders
Drug Dependence
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Psychiatric disorders
Major Depression
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.19%
2/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Psychiatric disorders
Mental Status Changes
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Renal and urinary disorders
Calculus Ureteric
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Renal and urinary disorders
Calculus Urinary
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Renal and urinary disorders
Cystitis Haemorrhagic
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.50%
3/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Renal and urinary disorders
Renal Colic
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
2/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Renal and urinary disorders
Renal Haemorrhage
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Renal and urinary disorders
Renal Impairment
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.57%
2/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.26%
3/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.19%
2/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.17%
2/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.17%
2/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.38%
4/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.85%
3/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.66%
4/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.35%
4/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.35%
4/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.98%
3/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.19%
2/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Surgical and medical procedures
Angioplasty
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Surgical and medical procedures
Catheterisation Cardiac
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Surgical and medical procedures
Coronary Arterial Stent Insertion
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Surgical and medical procedures
Coronary Artery Bypass
|
0.26%
3/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.65%
2/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.19%
2/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
2/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Surgical and medical procedures
Coronary Revascularisation
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.38%
4/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
2/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Surgical and medical procedures
Elective Procedure
|
0.17%
2/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Surgical and medical procedures
Elective Surgery
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Surgical and medical procedures
Implantable Defibrillator Insertion
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Surgical and medical procedures
Percutaneous Coronary Intervention
|
0.43%
5/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.57%
6/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
2/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Surgical and medical procedures
Surgery
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Vascular disorders
Aortic Aneurysm
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Vascular disorders
Aortic Arteriosclerosis
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Vascular disorders
Aortic Stenosis
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Vascular disorders
Arteriovenous Fistula
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Vascular disorders
Femoral Arterial Stenosis
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Vascular disorders
Femoral Artery Occlusion
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Vascular disorders
Haematoma
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Vascular disorders
Hypertension
|
0.17%
2/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.48%
5/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
2/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Vascular disorders
Hypertensive Crisis
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Vascular disorders
Iliac Artery Occlusion
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Vascular disorders
Intermittent Claudication
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Vascular disorders
Ischaemia
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.10%
1/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Vascular disorders
Neovascularisation
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Vascular disorders
Orthostatic Hypotension
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.17%
1/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.28%
1/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Vascular disorders
Phlebitis
|
0.00%
0/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.33%
1/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Vascular disorders
Thrombosis
|
0.09%
1/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
0.00%
0/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
Other adverse events
| Measure |
Placebo
n=1153 participants at risk
One placebo tablet twice daily for 6 months.
|
Riva 5 mg Total Daily Dose (TDD)
n=307 participants at risk
Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
|
Riva 10 mg TDD
n=1046 participants at risk
Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
|
Riva 15 mg TDD
n=353 participants at risk
Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
|
Riva 20 mg TDD
n=603 participants at risk
Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
3.8%
44/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
5.2%
16/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
4.1%
43/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
2.3%
8/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
3.6%
22/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Gastrointestinal disorders
Gingival Bleeding
|
1.1%
13/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
1.3%
4/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
4.5%
47/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
9.1%
32/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
5.5%
33/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
General disorders
Chest Pain
|
7.9%
91/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
8.5%
26/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
9.5%
99/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
8.8%
31/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
8.0%
48/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Injury, poisoning and procedural complications
Contusion
|
2.9%
33/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
2.6%
8/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
3.8%
40/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
5.1%
18/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
5.1%
31/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Nervous system disorders
Dizziness
|
4.1%
47/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
5.2%
16/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
3.1%
32/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
2.5%
9/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
3.0%
18/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.1%
24/1153
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
3.6%
11/307
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
8.5%
89/1046
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
12.5%
44/353
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
7.6%
46/603
Only Treatment-Emergent Adverse Events are presented in the following sections, called as Frequent Adverse Events and Serious Adverse Events
|
Additional Information
VP FRANCHISE MED LDR
Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
Phone: 1 908 927 7767
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60