Trial Outcomes & Findings for Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement (NCT NCT01240902)
NCT ID: NCT01240902
Last Updated: 2022-10-25
Results Overview
All-cause Death or Major Stroke (Extreme Risk- Medtronic CoreValve® System); All-cause Mortality (High Risk Surgical- Medtronic CoreValve® System vs. Surgical Valve)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1453 participants
Primary outcome timeframe
1 year
Results posted on
2022-10-25
Participant Flow
Between Feb 17, 2011 and Aug 23, 2013, 656 subjects were enrolled into the CoreValve US Pivotal Trial Extreme Risk study at 41 of the 43 activated centers in the United States. Between February 2, 2011 and July 23, 2013, 797 subjects were enrolled into the CoreValve US Pivotal Trial High Risk study at 45 centers in the United States.
The first 3 successfully enrolled and implanted iliofemoral subjects at each implanting site, inclusive of both the High Risk Surgical and Extreme Risk patient populations were considered roll-in subjects, and were automatically assigned to undergo Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI).
Participant milestones
| Measure |
Extreme Risk: TAVI Iliofemoral
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
|
Extreme Risk: TAVI Non-Iliofemoral
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
|
High Risk: TAVI
High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
|
High Risk: SAVR
High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
500
|
156
|
395
|
402
|
|
Overall Study
COMPLETED
|
289
|
77
|
295
|
237
|
|
Overall Study
NOT COMPLETED
|
211
|
79
|
100
|
165
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement
Baseline characteristics by cohort
| Measure |
Extreme Risk: TAVI Iliofemoral
n=489 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
|
Extreme Risk: TAVI Non-Iliofemoral
n=150 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
|
High Risk: TAVI
n=391 Participants
High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
|
High Risk: SAVR
n=359 Participants
High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
|
Total
n=1389 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
83.2 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
81.3 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
83.2 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
83.3 years
STANDARD_DEVIATION 6.4 • n=4 Participants
|
83.0 years
STANDARD_DEVIATION 7.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
255 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
171 Participants
n=4 Participants
|
692 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
234 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
207 Participants
n=5 Participants
|
188 Participants
n=4 Participants
|
697 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
4 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
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
|
|
Race/Ethnicity, Customized
Black or African American
|
19 participants
n=5 Participants
|
5 participants
n=7 Participants
|
3 participants
n=5 Participants
|
11 participants
n=4 Participants
|
38 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
468 participants
n=5 Participants
|
143 participants
n=7 Participants
|
387 participants
n=5 Participants
|
343 participants
n=4 Participants
|
1341 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
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
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
4 participants
n=21 Participants
|
|
Body Surface Area
|
1.8 m^2
STANDARD_DEVIATION 0.3 • n=5 Participants
|
1.8 m^2
STANDARD_DEVIATION 0.2 • n=7 Participants
|
1.8 m^2
STANDARD_DEVIATION 0.2 • n=5 Participants
|
1.9 m^2
STANDARD_DEVIATION 0.2 • n=4 Participants
|
1.8 m^2
STANDARD_DEVIATION 0.2 • n=21 Participants
|
|
NYHA Classification
NYHA I
|
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
|
|
NYHA Classification
NYHA II
|
40 participants
n=5 Participants
|
12 participants
n=7 Participants
|
57 participants
n=5 Participants
|
47 participants
n=4 Participants
|
156 participants
n=21 Participants
|
|
NYHA Classification
NYHA III
|
313 participants
n=5 Participants
|
98 participants
n=7 Participants
|
255 participants
n=5 Participants
|
250 participants
n=4 Participants
|
916 participants
n=21 Participants
|
|
NYHA Classification
NYHA IV
|
136 participants
n=5 Participants
|
40 participants
n=7 Participants
|
79 participants
n=5 Participants
|
62 participants
n=4 Participants
|
317 participants
n=21 Participants
|
|
Society of Thoracic Surgeons (STS) Risk Score
|
10.3 % risk of mortality or morbidity
STANDARD_DEVIATION 5.5 • n=5 Participants
|
10.7 % risk of mortality or morbidity
STANDARD_DEVIATION 5.7 • n=7 Participants
|
7.3 % risk of mortality or morbidity
STANDARD_DEVIATION 3.0 • n=5 Participants
|
7.5 % risk of mortality or morbidity
STANDARD_DEVIATION 3.3 • n=4 Participants
|
8.8 % risk of mortality or morbidity
STANDARD_DEVIATION 4.7 • n=21 Participants
|
|
Logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE)
|
22.6 %
STANDARD_DEVIATION 17.1 • n=5 Participants
|
22.9 %
STANDARD_DEVIATION 15.9 • n=7 Participants
|
17.7 %
STANDARD_DEVIATION 13.0 • n=5 Participants
|
18.8 %
STANDARD_DEVIATION 13.2 • n=4 Participants
|
20.3 %
STANDARD_DEVIATION 15.1 • n=21 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Participant Population= Consisted of all subjects with an attempted implant procedure.
All-cause Death or Major Stroke (Extreme Risk- Medtronic CoreValve® System); All-cause Mortality (High Risk Surgical- Medtronic CoreValve® System vs. Surgical Valve)
Outcome measures
| Measure |
Extreme Risk: TAVI Iliofemoral
n=489 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
|
Extreme Risk: TAVI Non-Iliofemoral
n=150 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
|
High Risk: TAVI
n=391 Participants
High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
|
High Risk: SAVR
n=359 Participants
High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
|
|---|---|---|---|---|
|
Extreme Risk: All-cause Death or Major Stroke; High Risk Surgical: All-cause Mortality
|
26.0 percentage of participants, Kaplan-Meier
|
39.3 percentage of participants, Kaplan-Meier
|
14.1 percentage of participants, Kaplan-Meier
|
18.9 percentage of participants, Kaplan-Meier
|
SECONDARY outcome
Timeframe: 30 day, 6 month, 1 year, 2 yearPopulation: Participant Population= Consisted of all subjects with an attempted implant procedure.
MACCE is defined as a composite of: * All Cause Mortality * Myocardial infarction (MI) * All Stroke * Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)
Outcome measures
| Measure |
Extreme Risk: TAVI Iliofemoral
n=489 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
|
Extreme Risk: TAVI Non-Iliofemoral
n=150 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
|
High Risk: TAVI
n=391 Participants
High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
|
High Risk: SAVR
n=359 Participants
High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
|
|---|---|---|---|---|
|
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)
30 day
|
12.3 percentage of participants, Kaplan-Meier
|
17.3 percentage of participants, Kaplan-Meier
|
7.7 percentage of participants, Kaplan-Meier
|
10.3 percentage of participants, Kaplan-Meier
|
|
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)
6 month
|
22.5 percentage of participants, Kaplan-Meier
|
34.7 percentage of participants, Kaplan-Meier
|
15.4 percentage of participants, Kaplan-Meier
|
21.0 percentage of participants, Kaplan-Meier
|
|
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)
1 year
|
29.2 percentage of participants, Kaplan-Meier
|
41.4 percentage of participants, Kaplan-Meier
|
20.5 percentage of participants, Kaplan-Meier
|
27.0 percentage of participants, Kaplan-Meier
|
|
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)
2 Year
|
42.3 percentage of participants, Kaplan-Meier
|
51.0 percentage of participants, Kaplan-Meier
|
29.7 percentage of participants, Kaplan-Meier
|
38.6 percentage of participants, Kaplan-Meier
|
SECONDARY outcome
Timeframe: 30 day, 6 month, 1 year, 2 yearPopulation: Participant Population= Consisted of all subjects with an attempted implant procedure.
Individual MACCE Components Include: * All Cause Mortality * MI * All stroke * Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)
Outcome measures
| Measure |
Extreme Risk: TAVI Iliofemoral
n=489 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
|
Extreme Risk: TAVI Non-Iliofemoral
n=150 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
|
High Risk: TAVI
n=391 Participants
High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
|
High Risk: SAVR
n=359 Participants
High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
|
|---|---|---|---|---|
|
The Occurrence of Individual MACCE Components
30 day All Cause Mortality
|
8.4 percentage of participants, Kaplan-Meier
|
11.3 percentage of participants, Kaplan-Meier
|
3.3 percentage of participants, Kaplan-Meier
|
4.5 percentage of participants, Kaplan-Meier
|
|
The Occurrence of Individual MACCE Components
30 day MI
|
1.2 percentage of participants, Kaplan-Meier
|
2.1 percentage of participants, Kaplan-Meier
|
0.8 percentage of participants, Kaplan-Meier
|
0.8 percentage of participants, Kaplan-Meier
|
|
The Occurrence of Individual MACCE Components
30 day Stroke
|
4.0 percentage of participants, Kaplan-Meier
|
8.8 percentage of participants, Kaplan-Meier
|
4.9 percentage of participants, Kaplan-Meier
|
6.2 percentage of participants, Kaplan-Meier
|
|
The Occurrence of Individual MACCE Components
30 day Reintervention
|
1.1 percentage of participants, Kaplan-Meier
|
0.0 percentage of participants, Kaplan-Meier
|
0.8 percentage of participants, Kaplan-Meier
|
0.0 percentage of participants, Kaplan-Meier
|
|
The Occurrence of Individual MACCE Components
6 month All Cause Mortality
|
18.6 percentage of participants, Kaplan-Meier
|
28.7 percentage of participants, Kaplan-Meier
|
9.0 percentage of participants, Kaplan-Meier
|
14.0 percentage of participants, Kaplan-Meier
|
|
The Occurrence of Individual MACCE Components
6 month MI
|
1.5 percentage of participants, Kaplan-Meier
|
2.1 percentage of participants, Kaplan-Meier
|
1.6 percentage of participants, Kaplan-Meier
|
1.1 percentage of participants, Kaplan-Meier
|
|
The Occurrence of Individual MACCE Components
6 month Stroke
|
5.2 percentage of participants, Kaplan-Meier
|
12.0 percentage of participants, Kaplan-Meier
|
7.3 percentage of participants, Kaplan-Meier
|
9.9 percentage of participants, Kaplan-Meier
|
|
The Occurrence of Individual MACCE Components
6 month Reintervention
|
1.5 percentage of participants, Kaplan-Meier
|
0.0 percentage of participants, Kaplan-Meier
|
1.0 percentage of participants, Kaplan-Meier
|
0.0 percentage of participants, Kaplan-Meier
|
|
The Occurrence of Individual MACCE Components
1 year All Cause Mortality
|
24.3 percentage of participants, Kaplan-Meier
|
36.0 percentage of participants, Kaplan-Meier
|
14.1 percentage of participants, Kaplan-Meier
|
18.9 percentage of participants, Kaplan-Meier
|
|
The Occurrence of Individual MACCE Components
1 year MI
|
2.0 percentage of participants, Kaplan-Meier
|
2.1 percentage of participants, Kaplan-Meier
|
1.9 percentage of participants, Kaplan-Meier
|
1.5 percentage of participants, Kaplan-Meier
|
|
The Occurrence of Individual MACCE Components
1 year Stroke
|
7.0 percentage of participants, Kaplan-Meier
|
13.0 percentage of participants, Kaplan-Meier
|
8.7 percentage of participants, Kaplan-Meier
|
12.5 percentage of participants, Kaplan-Meier
|
|
The Occurrence of Individual MACCE Components
1 year Reintervention
|
1.8 percentage of participants, Kaplan-Meier
|
1.0 percentage of participants, Kaplan-Meier
|
2.2 percentage of participants, Kaplan-Meier
|
0.0 percentage of participants, Kaplan-Meier
|
|
The Occurrence of Individual MACCE Components
2 year All Cause Mortality
|
36.6 percentage of participants, Kaplan-Meier
|
44.9 percentage of participants, Kaplan-Meier
|
22.2 percentage of participants, Kaplan-Meier
|
28.6 percentage of participants, Kaplan-Meier
|
|
The Occurrence of Individual MACCE Components
2 year MI
|
2.8 percentage of participants, Kaplan-Meier
|
3.2 percentage of participants, Kaplan-Meier
|
1.9 percentage of participants, Kaplan-Meier
|
2.3 percentage of participants, Kaplan-Meier
|
|
The Occurrence of Individual MACCE Components
2 year Stroke
|
8.6 percentage of participants, Kaplan-Meier
|
16.1 percentage of participants, Kaplan-Meier
|
10.9 percentage of participants, Kaplan-Meier
|
16.6 percentage of participants, Kaplan-Meier
|
|
The Occurrence of Individual MACCE Components
2 year Reintervention
|
1.8 percentage of participants, Kaplan-Meier
|
1.0 percentage of participants, Kaplan-Meier
|
2.5 percentage of participants, Kaplan-Meier
|
0.4 percentage of participants, Kaplan-Meier
|
SECONDARY outcome
Timeframe: 30 day, 6 month, 1 year, 2 yearPopulation: Participant Population= Consisted of all subjects with an attempted implant procedure.
MAEs Include: * MACCE * Acute Kidney Injury * Cardiac Tamponade * Prosthetic Valve Dysfunction * Cardiogenic Shock * Valve Endocarditis * Life-Threatening, Disabling or Major Bleeding * Major Vascular Complication * Cardiac Perforation * Device Migration/Valve Embolism
Outcome measures
| Measure |
Extreme Risk: TAVI Iliofemoral
n=489 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
|
Extreme Risk: TAVI Non-Iliofemoral
n=150 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
|
High Risk: TAVI
n=391 Participants
High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
|
High Risk: SAVR
n=359 Participants
High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
|
|---|---|---|---|---|
|
Major Adverse Events (MAEs)
30 day
|
54.2 percentage of participants, Kaplan-Meier
|
69.3 percentage of participants, Kaplan-Meier
|
52.4 percentage of participants, Kaplan-Meier
|
50.2 percentage of participants, Kaplan-Meier
|
|
Major Adverse Events (MAEs)
6 month
|
60.5 percentage of participants, Kaplan-Meier
|
76.0 percentage of participants, Kaplan-Meier
|
58.6 percentage of participants, Kaplan-Meier
|
76.4 percentage of participants, Kaplan-Meier
|
|
Major Adverse Events (MAEs)
1 year
|
63.4 percentage of participants, Kaplan-Meier
|
80.0 percentage of participants, Kaplan-Meier
|
60.1 percentage of participants, Kaplan-Meier
|
59.8 percentage of participants, Kaplan-Meier
|
|
Major Adverse Events (MAEs)
2 year
|
71.3 percentage of participants, Kaplan-Meier
|
84.0 percentage of participants, Kaplan-Meier
|
66.4 percentage of participants, Kaplan-Meier
|
66.8 percentage of participants, Kaplan-Meier
|
SECONDARY outcome
Timeframe: 30 day, 6 month, 1 year, 2 yearPopulation: Participant Population= Consisted of all subjects with an attempted implant procedure.
Outcome measures
| Measure |
Extreme Risk: TAVI Iliofemoral
n=489 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
|
Extreme Risk: TAVI Non-Iliofemoral
n=150 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
|
High Risk: TAVI
n=391 Participants
High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
|
High Risk: SAVR
n=359 Participants
High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
|
|---|---|---|---|---|
|
Conduction Disturbance Requiring Permanent Pacemaker Implantation
30 day
|
21.6 percentage of participants, Kaplan-Meier
|
16.4 percentage of participants, Kaplan-Meier
|
20.0 percentage of participants, Kaplan-Meier
|
7.1 percentage of participants, Kaplan-Meier
|
|
Conduction Disturbance Requiring Permanent Pacemaker Implantation
6 month
|
24.4 percentage of participants, Kaplan-Meier
|
20.5 percentage of participants, Kaplan-Meier
|
21.9 percentage of participants, Kaplan-Meier
|
9.9 percentage of participants, Kaplan-Meier
|
|
Conduction Disturbance Requiring Permanent Pacemaker Implantation
1 year
|
26.4 percentage of participants, Kaplan-Meier
|
21.5 percentage of participants, Kaplan-Meier
|
22.5 percentage of participants, Kaplan-Meier
|
11.6 percentage of participants, Kaplan-Meier
|
|
Conduction Disturbance Requiring Permanent Pacemaker Implantation
2 year
|
28.8 percentage of participants, Kaplan-Meier
|
22.6 percentage of participants, Kaplan-Meier
|
25.8 percentage of participants, Kaplan-Meier
|
12.8 percentage of participants, Kaplan-Meier
|
SECONDARY outcome
Timeframe: 30 day, 6 month, 1 year, 2 yearPopulation: Participant Population= Consisted of all subjects with an attempted implant procedure.
Change from baseline (continuous variable). A positive number corresponds to NYHA worsening; a negative number corresponds to NYHA improvement. New York Heart Association (NYHA) Classification: Class I: Subjects with cardiac disease but without resulting limitations of physical activity. Class I: Subjects with cardiac disease resulting in slight limitation of physical activity. Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.
Outcome measures
| Measure |
Extreme Risk: TAVI Iliofemoral
n=489 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
|
Extreme Risk: TAVI Non-Iliofemoral
n=150 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
|
High Risk: TAVI
n=391 Participants
High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
|
High Risk: SAVR
n=359 Participants
High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
|
|---|---|---|---|---|
|
Change in NYHA Class
30 day
|
-1.3 average classification level change
Standard Deviation 0.9
|
-1.0 average classification level change
Standard Deviation 0.8
|
-1.3 average classification level change
Standard Deviation 0.8
|
-1.0 average classification level change
Standard Deviation 0.9
|
|
Change in NYHA Class
6 month
|
-1.6 average classification level change
Standard Deviation 0.9
|
-1.4 average classification level change
Standard Deviation 0.8
|
-1.5 average classification level change
Standard Deviation 0.8
|
-1.4 average classification level change
Standard Deviation 0.8
|
|
Change in NYHA Class
1 year
|
-1.6 average classification level change
Standard Deviation 0.9
|
-1.4 average classification level change
Standard Deviation 0.8
|
-1.5 average classification level change
Standard Deviation 0.8
|
-1.5 average classification level change
Standard Deviation 0.8
|
|
Change in NYHA Class
2 year
|
-1.6 average classification level change
Standard Deviation 0.8
|
-1.4 average classification level change
Standard Deviation 0.7
|
-1.5 average classification level change
Standard Deviation 0.8
|
-1.5 average classification level change
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 30 day, 1 yearPopulation: Participant Population= Consisted of all subjects with an attempted implant procedure.
Change in distance walked during 6MWT from baseline
Outcome measures
| Measure |
Extreme Risk: TAVI Iliofemoral
n=489 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
|
Extreme Risk: TAVI Non-Iliofemoral
n=150 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
|
High Risk: TAVI
n=391 Participants
High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
|
High Risk: SAVR
n=359 Participants
High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
|
|---|---|---|---|---|
|
Change in Distance Walked During 6-Minute Walk Test (6MWT)
30 day
|
19.6 meters
Standard Deviation 109.1
|
13.3 meters
Standard Deviation 110.0
|
25.8 meters
Standard Deviation 105.5
|
-6.9 meters
Standard Deviation 89.8
|
|
Change in Distance Walked During 6-Minute Walk Test (6MWT)
1 year
|
13.9 meters
Standard Deviation 140.4
|
22.2 meters
Standard Deviation 136.2
|
27.0 meters
Standard Deviation 114.3
|
24.0 meters
Standard Deviation 111.8
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participant Population= Consisted of all subjects with an attempted implant procedure.
Outcome measures
| Measure |
Extreme Risk: TAVI Iliofemoral
n=489 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
|
Extreme Risk: TAVI Non-Iliofemoral
n=150 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
|
High Risk: TAVI
n=391 Participants
High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
|
High Risk: SAVR
n=359 Participants
High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
|
|---|---|---|---|---|
|
Ratio of Days Alive Out of Hospital Versus Total Days Alive
|
0.86 ratio of days alive and out of hospital
Standard Deviation 0.28
|
0.81 ratio of days alive and out of hospital
Standard Deviation 0.31
|
0.92 ratio of days alive and out of hospital
Standard Deviation 0.20
|
0.89 ratio of days alive and out of hospital
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: 30 day, 6 month, 1 year, 2 yearPopulation: Participant Population= Consisted of all subjects with an attempted implant procedure.
QoL summary score change from baseline using the following measures: * Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. * 12 Item Short Form Health Survey (SF-12): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. * European QoL (EQ-5D): Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state.
Outcome measures
| Measure |
Extreme Risk: TAVI Iliofemoral
n=489 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
|
Extreme Risk: TAVI Non-Iliofemoral
n=150 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
|
High Risk: TAVI
n=391 Participants
High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
|
High Risk: SAVR
n=359 Participants
High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
|
|---|---|---|---|---|
|
Quality of Life (QoL) Change
30 day KCCQ- Overall
|
24.2 units on a scale
Standard Deviation 28.9
|
7.9 units on a scale
Standard Deviation 33.5
|
19.0 units on a scale
Standard Deviation 29.4
|
4.3 units on a scale
Standard Deviation 28.1
|
|
Quality of Life (QoL) Change
30 day KCCQ- Clinical
|
20.2 units on a scale
Standard Deviation 28.0
|
6.8 units on a scale
Standard Deviation 32.0
|
14.7 units on a scale
Standard Deviation 28.6
|
2.7 units on a scale
Standard Deviation 27.1
|
|
Quality of Life (QoL) Change
30 day SF-12-Physical
|
5.9 units on a scale
Standard Deviation 10.4
|
1.9 units on a scale
Standard Deviation 10.4
|
4.9 units on a scale
Standard Deviation 10.2
|
-0.0 units on a scale
Standard Deviation 10.1
|
|
Quality of Life (QoL) Change
30 day SF-12-Mental
|
3.7 units on a scale
Standard Deviation 14.2
|
-1.7 units on a scale
Standard Deviation 16.2
|
2.6 units on a scale
Standard Deviation 13.1
|
-2.5 units on a scale
Standard Deviation 13.4
|
|
Quality of Life (QoL) Change
30 day EQ-5D
|
0.09 units on a scale
Standard Deviation 0.29
|
0.00 units on a scale
Standard Deviation 0.30
|
0.04 units on a scale
Standard Deviation 0.24
|
-0.07 units on a scale
Standard Deviation 0.26
|
|
Quality of Life (QoL) Change
6 month KCCQ-Overall
|
27.4 units on a scale
Standard Deviation 27.0
|
23.1 units on a scale
Standard Deviation 28.3
|
24.8 units on a scale
Standard Deviation 26.9
|
22.9 units on a scale
Standard Deviation 26.4
|
|
Quality of Life (QoL) Change
6 month KCCQ- Clinical
|
22.2 units on a scale
Standard Deviation 26.1
|
17.5 units on a scale
Standard Deviation 26.6
|
18.6 units on a scale
Standard Deviation 25.7
|
17.7 units on a scale
Standard Deviation 25.7
|
|
Quality of Life (QoL) Change
6 month SF-12-Physical
|
5.2 units on a scale
Standard Deviation 11.3
|
4.5 units on a scale
Standard Deviation 8.9
|
6.3 units on a scale
Standard Deviation 11.0
|
6.2 units on a scale
Standard Deviation 9.9
|
|
Quality of Life (QoL) Change
6 month SF-12-Mental
|
4.6 units on a scale
Standard Deviation 13.6
|
4.4 units on a scale
Standard Deviation 13.8
|
4.6 units on a scale
Standard Deviation 11.8
|
2.6 units on a scale
Standard Deviation 13.1
|
|
Quality of Life (QoL) Change
6 month EQ-5D
|
0.09 units on a scale
Standard Deviation 0.22
|
0.05 units on a scale
Standard Deviation 0.21
|
0.05 units on a scale
Standard Deviation 0.22
|
0.04 units on a scale
Standard Deviation 0.17
|
|
Quality of Life (QoL) Change
1 year KCCQ-Overall
|
27.9 units on a scale
Standard Deviation 27.1
|
21.9 units on a scale
Standard Deviation 26.8
|
23.2 units on a scale
Standard Deviation 25.4
|
21.8 units on a scale
Standard Deviation 26.5
|
|
Quality of Life (QoL) Change
1 year KCCQ- Clinical
|
20.8 units on a scale
Standard Deviation 26.8
|
18.1 units on a scale
Standard Deviation 24.9
|
16.7 units on a scale
Standard Deviation 25.5
|
15.2 units on a scale
Standard Deviation 26.0
|
|
Quality of Life (QoL) Change
1 year SF-12-Physical
|
5.5 units on a scale
Standard Deviation 10.8
|
4.6 units on a scale
Standard Deviation 10.0
|
6.0 units on a scale
Standard Deviation 11.5
|
5.3 units on a scale
Standard Deviation 10.3
|
|
Quality of Life (QoL) Change
1 year SF-12-Mental
|
5.2 units on a scale
Standard Deviation 13.7
|
2.4 units on a scale
Standard Deviation 14.3
|
4.5 units on a scale
Standard Deviation 11.8
|
3.2 units on a scale
Standard Deviation 12.1
|
|
Quality of Life (QoL) Change
1 year EQ-5D
|
0.06 units on a scale
Standard Deviation 0.25
|
0.05 units on a scale
Standard Deviation 0.25
|
0.04 units on a scale
Standard Deviation 0.19
|
0.01 units on a scale
Standard Deviation 0.19
|
|
Quality of Life (QoL) Change
2 year KCCQ - Overall
|
25.2 units on a scale
Standard Deviation 27.2
|
14.9 units on a scale
Standard Deviation 29.5
|
22.2 units on a scale
Standard Deviation 26.5
|
18.7 units on a scale
Standard Deviation 25.6
|
|
Quality of Life (QoL) Change
2 year KCCQ - Clinical
|
18.8 units on a scale
Standard Deviation 26.1
|
11.6 units on a scale
Standard Deviation 26.9
|
14.6 units on a scale
Standard Deviation 26.0
|
12.6 units on a scale
Standard Deviation 25.8
|
|
Quality of Life (QoL) Change
2 year SF-12 - Physical
|
4.0 units on a scale
Standard Deviation 11.2
|
1.9 units on a scale
Standard Deviation 11.9
|
5.0 units on a scale
Standard Deviation 12.1
|
4.3 units on a scale
Standard Deviation 10.2
|
|
Quality of Life (QoL) Change
2 year SF-12 - Mental
|
3.8 units on a scale
Standard Deviation 15.3
|
2.2 units on a scale
Standard Deviation 14.8
|
3.6 units on a scale
Standard Deviation 13.0
|
1.7 units on a scale
Standard Deviation 13.0
|
|
Quality of Life (QoL) Change
2 year EQ-5D
|
0.04 units on a scale
Standard Deviation 0.25
|
0.03 units on a scale
Standard Deviation 0.26
|
-0.01 units on a scale
Standard Deviation 0.24
|
-0.01 units on a scale
Standard Deviation 0.21
|
SECONDARY outcome
Timeframe: 30 day, 6 month, 1 year, 2 yearPopulation: Participant Population= Consisted of all subjects with a valve implanted.
Using the following measures: \- Effective Orifice Area (EOA)
Outcome measures
| Measure |
Extreme Risk: TAVI Iliofemoral
n=486 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
|
Extreme Risk: TAVI Non-Iliofemoral
n=148 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
|
High Risk: TAVI
n=390 Participants
High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
|
High Risk: SAVR
n=354 Participants
High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
|
|---|---|---|---|---|
|
Echocardiographic Assessment of Valve Performance
30 day EOA
|
1.86 cm^2
Standard Deviation 0.56
|
1.82 cm^2
Standard Deviation 0.64
|
1.94 cm^2
Standard Deviation 0.56
|
1.60 cm^2
Standard Deviation 0.51
|
|
Echocardiographic Assessment of Valve Performance
6 month EOA
|
1.88 cm^2
Standard Deviation 0.55
|
1.85 cm^2
Standard Deviation 0.51
|
1.91 cm^2
Standard Deviation 0.53
|
1.56 cm^2
Standard Deviation 0.49
|
|
Echocardiographic Assessment of Valve Performance
1 year EOA
|
1.88 cm^2
Standard Deviation 0.54
|
1.85 cm^2
Standard Deviation 0.51
|
1.91 cm^2
Standard Deviation 0.52
|
1.57 cm^2
Standard Deviation 0.49
|
|
Echocardiographic Assessment of Valve Performance
2 year EOA
|
1.86 cm^2
Standard Deviation 0.55
|
1.83 cm^2
Standard Deviation 0.58
|
1.87 cm^2
Standard Deviation 0.48
|
1.51 cm^2
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: 30 day, 6 month, 1 year, 2 yearPopulation: Participant Population= Consisted of all subjects with a valve implanted.
Using the following measures: \- Transvalvular Mean Gradient
Outcome measures
| Measure |
Extreme Risk: TAVI Iliofemoral
n=486 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
|
Extreme Risk: TAVI Non-Iliofemoral
n=148 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
|
High Risk: TAVI
n=390 Participants
High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
|
High Risk: SAVR
n=354 Participants
High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
|
|---|---|---|---|---|
|
Echocardiographic Assessment of Valve Performance
6 month Mean Gradient
|
9.10 mmHg
Standard Deviation 3.89
|
9.42 mmHg
Standard Deviation 5.60
|
9.08 mmHg
Standard Deviation 4.08
|
12.12 mmHg
Standard Deviation 6.31
|
|
Echocardiographic Assessment of Valve Performance
1 year Mean Gradient
|
8.86 mmHg
Standard Deviation 4.09
|
9.46 mmHg
Standard Deviation 5.65
|
9.09 mmHg
Standard Deviation 3.49
|
12.44 mmHg
Standard Deviation 7.36
|
|
Echocardiographic Assessment of Valve Performance
30 day Mean Gradient
|
8.68 mmHg
Standard Deviation 4.16
|
9.74 mmHg
Standard Deviation 5.82
|
8.88 mmHg
Standard Deviation 3.86
|
11.72 mmHg
Standard Deviation 5.70
|
|
Echocardiographic Assessment of Valve Performance
2 year Mean Gradient
|
8.70 mmHg
Standard Deviation 4.22
|
9.24 mmHg
Standard Deviation 5.35
|
8.47 mmHg
Standard Deviation 3.76
|
12.05 mmHg
Standard Deviation 6.32
|
SECONDARY outcome
Timeframe: 30 day, 6 month, 1 year, 2 yearPopulation: Participant Population= Consisted of all subjects with a valve implanted.
Using the following measure: \- Degree of Aortic Valve Regurgitation (Transvalvular and Paravalvular)
Outcome measures
| Measure |
Extreme Risk: TAVI Iliofemoral
n=486 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
|
Extreme Risk: TAVI Non-Iliofemoral
n=148 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
|
High Risk: TAVI
n=390 Participants
High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
|
High Risk: SAVR
n=354 Participants
High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
|
|---|---|---|---|---|
|
Echocardiographic Assessment of Valve Performance
30 day Total Aortic Regurgitation- None
|
9.1 percentage of participants
|
19.0 percentage of participants
|
12.2 percentage of participants
|
65.0 percentage of participants
|
|
Echocardiographic Assessment of Valve Performance
30 day Total Aortic Regurgitation- Trivial
|
32.7 percentage of participants
|
33.9 percentage of participants
|
41.4 percentage of participants
|
23.0 percentage of participants
|
|
Echocardiographic Assessment of Valve Performance
30 day Total Aortic Regurgitation- Mild
|
43.0 percentage of participants
|
34.7 percentage of participants
|
36.4 percentage of participants
|
10.7 percentage of participants
|
|
Echocardiographic Assessment of Valve Performance
30 day Total Aortic Regurgitation- Moderate
|
14.1 percentage of participants
|
10.7 percentage of participants
|
8.1 percentage of participants
|
1.3 percentage of participants
|
|
Echocardiographic Assessment of Valve Performance
30 day Total Aortic Regurgitation- Severe
|
1.2 percentage of participants
|
1.7 percentage of participants
|
1.9 percentage of participants
|
0.0 percentage of participants
|
|
Echocardiographic Assessment of Valve Performance
6 month Total Aortic Regurgitation- None
|
19.9 percentage of participants
|
33.3 percentage of participants
|
21.6 percentage of participants
|
60.6 percentage of participants
|
|
Echocardiographic Assessment of Valve Performance
6 month Total Aortic Regurgitation- Trivial
|
33.5 percentage of participants
|
27.1 percentage of participants
|
37.2 percentage of participants
|
28.0 percentage of participants
|
|
Echocardiographic Assessment of Valve Performance
6 month Total Aortic Regurgitation- Mild
|
36.5 percentage of participants
|
35.4 percentage of participants
|
29.7 percentage of participants
|
9.8 percentage of participants
|
|
Echocardiographic Assessment of Valve Performance
6 month Total Aortic Regurgitation- Moderate
|
9.8 percentage of participants
|
4.2 percentage of participants
|
10.0 percentage of participants
|
1.6 percentage of participants
|
|
Echocardiographic Assessment of Valve Performance
6 month Total Aortic Regurgitation- Severe
|
0.3 percentage of participants
|
0.0 percentage of participants
|
1.6 percentage of participants
|
0.0 percentage of participants
|
|
Echocardiographic Assessment of Valve Performance
1 year Total Aortic Regurgitation- None
|
21.5 percentage of participants
|
39.0 percentage of participants
|
28.3 percentage of participants
|
68.1 percentage of participants
|
|
Echocardiographic Assessment of Valve Performance
1 year Total Aortic Regurgitation- Trivial
|
40.6 percentage of participants
|
36.6 percentage of participants
|
35.7 percentage of participants
|
21.7 percentage of participants
|
|
Echocardiographic Assessment of Valve Performance
1 year Total Aortic Regurgitation- Mild
|
31.5 percentage of participants
|
20.7 percentage of participants
|
29.0 percentage of participants
|
8.8 percentage of participants
|
|
Echocardiographic Assessment of Valve Performance
1 year Total Aortic Regurgitation- Moderate
|
6.4 percentage of participants
|
2.4 percentage of participants
|
6.7 percentage of participants
|
0.9 percentage of participants
|
|
Echocardiographic Assessment of Valve Performance
1 year Total Aortic Regurgitation- Severe
|
0.0 percentage of participants
|
1.2 percentage of participants
|
0.3 percentage of participants
|
0.4 percentage of participants
|
|
Echocardiographic Assessment of Valve Performance
2 year Total Aortic Regurgitation - None
|
31.0 percentage of participants
|
35.3 percentage of participants
|
32.8 percentage of participants
|
58.5 percentage of participants
|
|
Echocardiographic Assessment of Valve Performance
2 year Total Aortic Regurgitation - Trivial
|
26.3 percentage of participants
|
36.8 percentage of participants
|
27.0 percentage of participants
|
27.3 percentage of participants
|
|
Echocardiographic Assessment of Valve Performance
2 year Total Aortic Regurgitation - Mild
|
36.1 percentage of participants
|
23.5 percentage of participants
|
32.0 percentage of participants
|
13.1 percentage of participants
|
|
Echocardiographic Assessment of Valve Performance
2 year Total Aortic Regurgitation - Moderate
|
6.7 percentage of participants
|
4.4 percentage of participants
|
6.6 percentage of participants
|
1.1 percentage of participants
|
|
Echocardiographic Assessment of Valve Performance
2 year Total Aortic Regurgitation - Severe
|
0.0 percentage of participants
|
0.0 percentage of participants
|
1.6 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: 30 day, 6 month, 1 year, 2 yearPopulation: Participant Population= Consisted of all subjects with an attempted implant procedure
Outcome measures
| Measure |
Extreme Risk: TAVI Iliofemoral
n=489 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
|
Extreme Risk: TAVI Non-Iliofemoral
n=150 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
|
High Risk: TAVI
n=391 Participants
High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
|
High Risk: SAVR
n=359 Participants
High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
|
|---|---|---|---|---|
|
Aortic Valve Hospitalizations
1 year
|
21.9 percentage of participants, Kaplan-Meier
|
21.2 percentage of participants, Kaplan-Meier
|
16.5 percentage of participants, Kaplan-Meier
|
14.0 percentage of participants, Kaplan-Meier
|
|
Aortic Valve Hospitalizations
30 day
|
6.7 percentage of participants, Kaplan-Meier
|
8.7 percentage of participants, Kaplan-Meier
|
3.9 percentage of participants, Kaplan-Meier
|
5.2 percentage of participants, Kaplan-Meier
|
|
Aortic Valve Hospitalizations
6 month
|
16.4 percentage of participants, Kaplan-Meier
|
18.3 percentage of participants, Kaplan-Meier
|
13.4 percentage of participants, Kaplan-Meier
|
9.0 percentage of participants, Kaplan-Meier
|
|
Aortic Valve Hospitalizations
2 year
|
29.5 percentage of participants, Kaplan-Meier
|
27.2 percentage of participants, Kaplan-Meier
|
24.2 percentage of participants, Kaplan-Meier
|
18.2 percentage of participants, Kaplan-Meier
|
SECONDARY outcome
Timeframe: 30 day, 6 month, 1 year, 2 yearPopulation: Participant Population= Consisted of all subjects with an attempted implant procedure.
Outcome measures
| Measure |
Extreme Risk: TAVI Iliofemoral
n=489 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
|
Extreme Risk: TAVI Non-Iliofemoral
n=150 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
|
High Risk: TAVI
n=391 Participants
High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
|
High Risk: SAVR
n=359 Participants
High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
|
|---|---|---|---|---|
|
Cardiovascular Deaths and Valve Related Deaths
30 day Cardiovascular Deaths
|
8.4 percentage of participants, Kaplan-Meier
|
11.3 percentage of participants, Kaplan-Meier
|
3.3 percentage of participants, Kaplan-Meier
|
4.5 percentage of participants, Kaplan-Meier
|
|
Cardiovascular Deaths and Valve Related Deaths
30 Day Valve Related Deaths
|
2.5 percentage of participants, Kaplan-Meier
|
2.8 percentage of participants, Kaplan-Meier
|
2.3 percentage of participants, Kaplan-Meier
|
0.6 percentage of participants, Kaplan-Meier
|
|
Cardiovascular Deaths and Valve Related Deaths
6 month Cardiovascular Deaths
|
15.0 percentage of participants, Kaplan-Meier
|
23.6 percentage of participants, Kaplan-Meier
|
7.4 percentage of participants, Kaplan-Meier
|
10.5 percentage of participants, Kaplan-Meier
|
|
Cardiovascular Deaths and Valve Related Deaths
6 month Valve Related Deaths
|
4.1 percentage of participants, Kaplan-Meier
|
4.5 percentage of participants, Kaplan-Meier
|
3.6 percentage of participants, Kaplan-Meier
|
1.8 percentage of participants, Kaplan-Meier
|
|
Cardiovascular Deaths and Valve Related Deaths
1 year Cardiovascular Deaths
|
18.3 percentage of participants, Kaplan-Meier
|
28.7 percentage of participants, Kaplan-Meier
|
10.6 percentage of participants, Kaplan-Meier
|
12.9 percentage of participants, Kaplan-Meier
|
|
Cardiovascular Deaths and Valve Related Deaths
1 year Valve Related Deaths
|
5.1 percentage of participants, Kaplan-Meier
|
5.4 percentage of participants, Kaplan-Meier
|
5.6 percentage of participants, Kaplan-Meier
|
2.2 percentage of participants, Kaplan-Meier
|
|
Cardiovascular Deaths and Valve Related Deaths
2 year Cardiovascular Deaths
|
26.2 percentage of participants, Kaplan-Meier
|
35.1 percentage of participants, Kaplan-Meier
|
15.4 percentage of participants, Kaplan-Meier
|
19.4 percentage of participants, Kaplan-Meier
|
|
Cardiovascular Deaths and Valve Related Deaths
2 year Valve Related Deaths
|
6.2 percentage of participants, Kaplan-Meier
|
7.5 percentage of participants, Kaplan-Meier
|
6.8 percentage of participants, Kaplan-Meier
|
4.2 percentage of participants, Kaplan-Meier
|
SECONDARY outcome
Timeframe: 30 day, 6 month, 1 year, 2 yearPopulation: Participant Population= Consisted of all subjects with an attempted implant procedure.
Strokes (of any severity) and TIAs
Outcome measures
| Measure |
Extreme Risk: TAVI Iliofemoral
n=489 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
|
Extreme Risk: TAVI Non-Iliofemoral
n=150 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
|
High Risk: TAVI
n=391 Participants
High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
|
High Risk: SAVR
n=359 Participants
High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
|
|---|---|---|---|---|
|
Strokes and Transient Ischemic Attacks (TIAs)
30 day
|
4.6 percentage of participants, Kaplan-Meier
|
10.2 percentage of participants, Kaplan-Meier
|
5.7 percentage of participants, Kaplan-Meier
|
6.5 percentage of participants, Kaplan-Meier
|
|
Strokes and Transient Ischemic Attacks (TIAs)
6 month
|
6.0 percentage of participants, Kaplan-Meier
|
14.3 percentage of participants, Kaplan-Meier
|
8.4 percentage of participants, Kaplan-Meier
|
10.8 percentage of participants, Kaplan-Meier
|
|
Strokes and Transient Ischemic Attacks (TIAs)
1 year
|
8.1 percentage of participants, Kaplan-Meier
|
15.2 percentage of participants, Kaplan-Meier
|
10.3 percentage of participants, Kaplan-Meier
|
14.1 percentage of participants, Kaplan-Meier
|
|
Strokes and Transient Ischemic Attacks (TIAs)
2 year
|
10.1 percentage of participants, Kaplan-Meier
|
19.5 percentage of participants, Kaplan-Meier
|
13.2 percentage of participants, Kaplan-Meier
|
17.8 percentage of participants, Kaplan-Meier
|
SECONDARY outcome
Timeframe: ProcedurePopulation: Participant Population= Consisted of all subjects with an attempted implant procedure.
Outcome measures
| Measure |
Extreme Risk: TAVI Iliofemoral
n=489 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
|
Extreme Risk: TAVI Non-Iliofemoral
n=150 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
|
High Risk: TAVI
n=391 Participants
High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
|
High Risk: SAVR
n=359 Participants
High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
|
|---|---|---|---|---|
|
Index Procedure Related MAEs
|
53.5 percentage of participants
|
68.9 percentage of participants
|
52.6 percentage of participants
|
49.9 percentage of participants
|
SECONDARY outcome
Timeframe: Number of days from admission to dischargePopulation: Participant Population= Consisted of all subjects with an attempted implant procedure.
Outcome measures
| Measure |
Extreme Risk: TAVI Iliofemoral
n=489 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
|
Extreme Risk: TAVI Non-Iliofemoral
n=150 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
|
High Risk: TAVI
n=391 Participants
High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
|
High Risk: SAVR
n=359 Participants
High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
|
|---|---|---|---|---|
|
Length of Index Procedure Hospital Stay
|
9.2 days
Standard Deviation 8.1
|
11.2 days
Standard Deviation 8.9
|
8.0 days
Standard Deviation 6.8
|
12.5 days
Standard Deviation 10.7
|
SECONDARY outcome
Timeframe: Number of days from admission to dischargePopulation: Participant Population= Consisted of all subjects with a TAVR index procedure who were evaluable for device success.
Medtronic CoreValve® System subjects only. Defined as: * Successful vascular access, delivery and deployment of the device, and successful retrieval of the delivery system, * Correct position of the device in the proper anatomical location (placement in the annulus with no impedance on device function), * Intended performance of the prosthetic valve (aortic valve area \> 1.2 cm2 for 26, 29 and 31mm valves, ≥ 0.9 cm2 for 23mm valve (by echocardiography using the continuity equation) and mean aortic valve gradient \< 20 mmHg or peak velocity \< 3 m/sec, without moderate or severe prosthetic valve aortic regurgitation) * Only one valve implanted in the proper anatomical location
Outcome measures
| Measure |
Extreme Risk: TAVI Iliofemoral
n=468 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
|
Extreme Risk: TAVI Non-Iliofemoral
n=141 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
|
High Risk: TAVI
n=378 Participants
High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
|
High Risk: SAVR
High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
|
|---|---|---|---|---|
|
Device Success
|
84.6 percentage of participants
|
88.7 percentage of participants
|
86.8 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Number of days from admission to dischargePopulation: Participant Population= Consisted of all subjects with a TAVR index procedure who were evaluable for procedural success.
Medtronic CoreValve® System subjects only. Defined as device success and absence of in-hospital MACCE.
Outcome measures
| Measure |
Extreme Risk: TAVI Iliofemoral
n=476 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
|
Extreme Risk: TAVI Non-Iliofemoral
n=142 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
|
High Risk: TAVI
n=384 Participants
High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
|
High Risk: SAVR
High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
|
|---|---|---|---|---|
|
Procedural Success
|
77.5 percentage of participants
|
77.5 percentage of participants
|
81.3 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 30 day, 6 month, 1 year, 2 yearPopulation: Participant Population= Consisted of all subjects with a valve implanted.
PVD was defined according to VARC I using the Core Lab Echocardiography assessments including aortic regurgitation (AR) and aortic stenosis (AS) evaluations. Total AR reported as moderate or severe was considered PVD. AS was defined as significant stenosis and considered PVD if one of the following was met: * Peak velocity \>4 m/s * Mean gradient \>35 mmHg * EOA \< 0.8 cm2 * TVIV1 / TVIV2 \< 0.25
Outcome measures
| Measure |
Extreme Risk: TAVI Iliofemoral
n=486 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
|
Extreme Risk: TAVI Non-Iliofemoral
n=148 Participants
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
|
High Risk: TAVI
n=390 Participants
High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
|
High Risk: SAVR
n=354 Participants
High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
|
|---|---|---|---|---|
|
Prosthetic Valve Dysfunction (PVD)
30 day Aortic Stenosis
|
2.3 percentage of participants
|
6.1 percentage of participants
|
3.1 percentage of participants
|
4.8 percentage of participants
|
|
Prosthetic Valve Dysfunction (PVD)
30 day Aortic Regurgitation
|
23.5 percentage of participants
|
16.9 percentage of participants
|
13.6 percentage of participants
|
1.7 percentage of participants
|
|
Prosthetic Valve Dysfunction (PVD)
6 month Aortic Stenosis
|
3.1 percentage of participants
|
6.1 percentage of participants
|
3.8 percentage of participants
|
6.5 percentage of participants
|
|
Prosthetic Valve Dysfunction (PVD)
6 month Aortic Regurgitation
|
26.1 percentage of participants
|
18.2 percentage of participants
|
17.2 percentage of participants
|
2.3 percentage of participants
|
|
Prosthetic Valve Dysfunction (PVD)
1 year Aortic Stenosis
|
3.5 percentage of participants
|
6.1 percentage of participants
|
4.9 percentage of participants
|
8.2 percentage of participants
|
|
Prosthetic Valve Dysfunction (PVD)
1 year Aortic Regurgitation
|
27.0 percentage of participants
|
19.6 percentage of participants
|
17.9 percentage of participants
|
2.8 percentage of participants
|
|
Prosthetic Valve Dysfunction (PVD)
2 year Aortic Stenosis
|
3.9 percentage of participants
|
6.8 percentage of participants
|
5.4 percentage of participants
|
9.3 percentage of participants
|
|
Prosthetic Valve Dysfunction (PVD)
2 year Aortic Regurgitation
|
27.8 percentage of participants
|
19.6 percentage of participants
|
19.7 percentage of participants
|
2.8 percentage of participants
|
Adverse Events
Extreme Risk: TAVI Iliofemoral
Serious events: 452 serious events
Other events: 440 other events
Deaths: 0 deaths
Extreme Risk: TAVI Non-Iliofemoral
Serious events: 142 serious events
Other events: 139 other events
Deaths: 0 deaths
High Risk: TAVI
Serious events: 346 serious events
Other events: 355 other events
Deaths: 0 deaths
High Risk: SAVR
Serious events: 324 serious events
Other events: 320 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Extreme Risk: TAVI Iliofemoral
n=489 participants at risk
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
|
Extreme Risk: TAVI Non-Iliofemoral
n=150 participants at risk
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
|
High Risk: TAVI
n=390 participants at risk
High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
|
High Risk: SAVR
n=357 participants at risk
High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Oesophageal Stenosis And Obstruction
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Oesophageal Ulcers And Perforation
|
0.41%
2/489 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.77%
3/390 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Oesophagitis (Excl Infective)
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Oral Soft Tissue Pain And Paraesthesia
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Eye disorders
Retinal, Choroid And Vitreous Infections And Inflammations
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Eye disorders
Visual Disorders Nec
|
0.41%
2/489 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Infections and infestations
Abdominal And Gastrointestinal Infections
|
1.2%
6/489 • Number of events 8 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.0%
4/390 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.1%
4/357 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Blood and lymphatic system disorders
Anaemia Deficiencies
|
0.41%
2/489 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.51%
2/390 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Blood and lymphatic system disorders
Anaemias Due To Chronic Disorders
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Blood and lymphatic system disorders
Anaemias Haemolytic Immune
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Blood and lymphatic system disorders
Anaemias Nec
|
28.6%
140/489 • Number of events 170 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
46.7%
70/150 • Number of events 75 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
27.2%
106/390 • Number of events 132 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
42.3%
151/357 • Number of events 173 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Blood and lymphatic system disorders
Coagulopathies
|
0.41%
2/489 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
2/150 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.1%
4/357 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Blood and lymphatic system disorders
Eosinophilic Disorders
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Blood and lymphatic system disorders
Haematological Disorders
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Blood and lymphatic system disorders
Leukocytoses Nec
|
1.0%
5/489 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.77%
3/390 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.1%
4/357 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Blood and lymphatic system disorders
Marrow Depression And Hypoplastic Anaemias
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.51%
2/390 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenias
|
2.2%
11/489 • Number of events 11 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.7%
4/150 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.1%
8/390 • Number of events 8 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
6.2%
22/357 • Number of events 22 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Cardiac disorders
Aortic Valvular Disorders
|
9.0%
44/489 • Number of events 45 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
8.0%
12/150 • Number of events 12 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
10.8%
42/390 • Number of events 42 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.8%
10/357 • Number of events 12 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Cardiac disorders
Cardiac Conduction Disorders
|
21.7%
106/489 • Number of events 109 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
16.0%
24/150 • Number of events 27 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
20.3%
79/390 • Number of events 85 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
5.0%
18/357 • Number of events 19 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Cardiac disorders
Cardiac Disorders Nec
|
1.8%
9/489 • Number of events 9 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.0%
3/150 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.8%
7/390 • Number of events 9 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.0%
7/357 • Number of events 7 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Cardiac disorders
Cardiac Signs And Symptoms Nec
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.1%
4/357 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Cardiac disorders
Cardiac Valve Disorders Nec
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Cardiac disorders
Cardiomyopathies
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.0%
4/390 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Cardiac disorders
Coronary Artery Disorders Nec
|
1.2%
6/489 • Number of events 6 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.7%
4/150 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.3%
9/390 • Number of events 9 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.1%
4/357 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Cardiac disorders
Heart Failures Nec
|
23.9%
117/489 • Number of events 186 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
19.3%
29/150 • Number of events 43 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
17.7%
69/390 • Number of events 95 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
17.4%
62/357 • Number of events 85 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Cardiac disorders
Ischaemic Coronary Artery Disorders
|
5.7%
28/489 • Number of events 30 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
5.3%
8/150 • Number of events 8 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
3.8%
15/390 • Number of events 17 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
3.4%
12/357 • Number of events 15 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Cardiac disorders
Mitral Valvular Disorders
|
1.8%
9/489 • Number of events 9 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
3.3%
5/150 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.77%
3/390 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.4%
5/357 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Cardiac disorders
Myocardial Disorders Nec
|
0.41%
2/489 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.56%
2/357 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Cardiac disorders
Noninfectious Pericarditis
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Cardiac disorders
Pericardial Disorders Nec
|
1.0%
5/489 • Number of events 7 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.7%
4/150 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
5/390 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.8%
10/357 • Number of events 10 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Cardiac disorders
Rate And Rhythm Disorders Nec
|
5.7%
28/489 • Number of events 29 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
4.0%
6/150 • Number of events 6 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
4.1%
16/390 • Number of events 18 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
5.3%
19/357 • Number of events 19 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Cardiac disorders
Right Ventricular Failures
|
0.61%
3/489 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Cardiac disorders
Supraventricular Arrhythmias
|
13.3%
65/489 • Number of events 79 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
11.3%
17/150 • Number of events 22 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
11.0%
43/390 • Number of events 46 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
19.3%
69/357 • Number of events 80 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Cardiac disorders
Tricuspid Valvular Disorders
|
0.41%
2/489 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.0%
3/150 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.56%
2/357 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Cardiac disorders
Ventricular Arrhythmias And Cardiac Arrest
|
9.8%
48/489 • Number of events 59 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
17.3%
26/150 • Number of events 30 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
6.9%
27/390 • Number of events 29 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
7.6%
27/357 • Number of events 27 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Congenital, familial and genetic disorders
Cardiac Septal Defects Congenital
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Congenital, familial and genetic disorders
Coagulation Disorders Congenital
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Congenital, familial and genetic disorders
Male Reproductive Tract Disorders Congenital
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Congenital, familial and genetic disorders
Vascular Anomalies Congenital Nec
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Ear and labyrinth disorders
Hearing Losses
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Ear and labyrinth disorders
Ear Disorders Nec
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Ear and labyrinth disorders
Inner Ear Signs And Symptoms
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Endocrine disorders
Thyroid Neoplasms
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Eye disorders
Blindness (Excl Colour Blindness)
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.51%
2/390 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Eye disorders
Cataract Conditions
|
0.41%
2/489 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Eye disorders
Corneal Infections, Oedemas And Inflammations
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Eye disorders
Lacrimal Disorders
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Eye disorders
Retinal Bleeding And Vascular Disorders (Excl Retinopathy)
|
0.41%
2/489 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Eye disorders
Retinal Structural Change, Deposit And Degeneration
|
0.20%
1/489 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Abdominal Wall Conditions Nec
|
0.20%
1/489 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Acute And Chronic Pancreatitis
|
0.82%
4/489 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.51%
2/390 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Anal And Rectal Ulcers And Perforation
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Benign Neoplasms Gastrointestinal (Excl Oral Cavity)
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Colitis (Excl Infective)
|
0.41%
2/489 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
2/150 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.1%
4/357 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Diaphragmatic Hernias
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Diarrhoea (Excl Infective)
|
0.82%
4/489 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.0%
3/150 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.77%
3/390 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.56%
2/357 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Diverticula
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.56%
2/357 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Duodenal And Small Intestinal Stenosis And Obstruction
|
0.41%
2/489 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.0%
3/150 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.51%
2/390 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.84%
3/357 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Duodenal Ulcers And Perforation
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.51%
2/390 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Dyspeptic Signs And Symptoms
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Faecal Abnormalities Nec
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Flatulence, Bloating And Distension
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Gastric And Oesophageal Haemorrhages
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Gastric Ulcers And Perforation
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.84%
3/357 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Gastritis (Excl Infective)
|
0.61%
3/489 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.51%
2/390 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.56%
2/357 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Gastrointestinal And Abdominal Pains (Excl Oral And Throat)
|
2.7%
13/489 • Number of events 15 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.7%
4/150 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.77%
3/390 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.56%
2/357 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Gastrointestinal Atonic And Hypomotility Disorders Nec
|
0.61%
3/489 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.77%
3/390 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Gastrointestinal Fistulae
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Gastrointestinal Necrosis And Gangrene (Excl Gangrenous Hernia)
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Gastrointestinal Disorders Nec
|
0.41%
2/489 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Gastrointestinal Signs And Symptoms Nec
|
3.1%
15/489 • Number of events 15 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
4.7%
7/150 • Number of events 7 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.8%
7/390 • Number of events 7 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
3.4%
12/357 • Number of events 13 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Gastrointestinal Spastic And Hypermotility Disorders
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Gastrointestinal Stenosis And Obstruction Nec
|
1.0%
5/489 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.77%
3/390 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.84%
3/357 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Gastrointestinal Ulcers And Perforation, Site Unspecified
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Gastrointestinal Vascular Occlusion And Infarction
|
0.61%
3/489 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Haemorrhoids And Gastrointestinal Varices (Excl Oesophageal)
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Inguinal Hernias
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Intestinal Haemorrhages
|
0.82%
4/489 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
5/390 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.1%
4/357 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Intestinal Ulcers And Perforation Nec
|
0.61%
3/489 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Nausea And Vomiting Symptoms
|
0.41%
2/489 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.77%
3/390 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.4%
5/357 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Non-Site Specific Gastrointestinal Haemorrhages
|
7.2%
35/489 • Number of events 40 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
12.0%
18/150 • Number of events 20 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
6.9%
27/390 • Number of events 29 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
4.5%
16/357 • Number of events 17 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Pancreatic Neoplasms
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Peritoneal And Retroperitoneal Disorders
|
0.20%
1/489 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
2/150 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.56%
2/357 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Peritoneal And Retroperitoneal Haemorrhages
|
1.0%
5/489 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.51%
2/390 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Umbilical Hernias
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
General disorders
Administration Site Reactions Nec
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
General disorders
Asthenic Conditions
|
2.2%
11/489 • Number of events 12 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.0%
3/150 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.3%
9/390 • Number of events 10 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.5%
9/357 • Number of events 9 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
General disorders
Body Temperature Altered
|
0.41%
2/489 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
General disorders
Cardiac Complications Associated With Device
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
General disorders
Complications Associated With Device Nec
|
0.82%
4/489 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
General disorders
Death And Sudden Death
|
2.0%
10/489 • Number of events 10 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
3.3%
5/150 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.5%
6/390 • Number of events 6 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.84%
3/357 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
General disorders
Device Issues Nec
|
8.2%
40/489 • Number of events 40 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
4.7%
7/150 • Number of events 7 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
7.2%
28/390 • Number of events 30 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.56%
2/357 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
General disorders
Device Malfunction Events Nec
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
5/390 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.4%
5/357 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
General disorders
Febrile Disorders
|
0.61%
3/489 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
2/150 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.8%
7/390 • Number of events 7 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.7%
6/357 • Number of events 6 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
General disorders
Feelings And Sensations Nec
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
General disorders
Gait Disturbances
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.77%
3/390 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
General disorders
General Signs And Symptoms Nec
|
1.4%
7/489 • Number of events 7 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
2/150 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.0%
4/390 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.4%
5/357 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
General disorders
Healing Abnormal Nec
|
0.41%
2/489 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
General disorders
Hernias Nec
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
General disorders
Implant And Catheter Site Reactions
|
0.61%
3/489 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.51%
2/390 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
General disorders
Inflammations
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
General disorders
Injection Site Reactions
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
General disorders
Mass Conditions Nec
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
General disorders
Oedema Nec
|
1.2%
6/489 • Number of events 7 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.5%
6/390 • Number of events 7 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.7%
6/357 • Number of events 6 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
General disorders
Pain And Discomfort Nec
|
5.3%
26/489 • Number of events 33 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
6.0%
9/150 • Number of events 11 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
5.9%
23/390 • Number of events 29 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
5.3%
19/357 • Number of events 22 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
General disorders
Product Physical Issues
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.51%
2/390 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
General disorders
Therapeutic And Nontherapeutic Responses
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
General disorders
Withdrawal And Rebound Effects
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Hepatobiliary disorders
Bile Duct Infections And Inflammations
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Hepatobiliary disorders
Cholecystitis And Cholelithiasis
|
0.61%
3/489 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.0%
4/390 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal Neoplasms Malignancy Unspecified Nec
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Hepatobiliary disorders
Hepatic And Hepatobiliary Disorders Nec
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Hepatobiliary disorders
Hepatic Failure And Associated Disorders
|
0.61%
3/489 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.84%
3/357 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Hepatic Fibrosis And Cirrhosis
|
0.61%
3/489 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Hepatobiliary disorders
Hepatocellular Damage And Hepatitis Nec
|
1.0%
5/489 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.56%
2/357 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Immune system disorders
Anaphylactic Responses
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Infections and infestations
Atypical Mycobacterial Infections
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Infections and infestations
Bacterial Infections Nec
|
4.5%
22/489 • Number of events 25 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
4.0%
6/150 • Number of events 6 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
3.8%
15/390 • Number of events 20 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
3.4%
12/357 • Number of events 12 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Infections and infestations
Bone And Joint Infections
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Infections and infestations
Candida Infections
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Infections and infestations
Cardiac Infections
|
1.2%
6/489 • Number of events 7 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.84%
3/357 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Infections and infestations
Central Nervous System And Spinal Infections
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Clostridia Infections
|
1.8%
9/489 • Number of events 9 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
2/150 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.5%
6/390 • Number of events 7 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.7%
6/357 • Number of events 6 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Infections and infestations
Ear Infections
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Infections and infestations
Enterobacter Infections
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.56%
2/357 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Infections and infestations
Enterococcal Infections
|
0.82%
4/489 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.56%
2/357 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Infections and infestations
Escherichia Infections
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Infections and infestations
Fungal Infections Nec
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Infections and infestations
Haemophilus Infections
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Infections and infestations
Herpes Viral Infections
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
2/150 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.51%
2/390 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Infections and infestations
Infections Nec
|
1.6%
8/489 • Number of events 8 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
2/150 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.5%
6/390 • Number of events 6 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.2%
8/357 • Number of events 8 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Infections and infestations
Infectious Transmissions
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Infections and infestations
Influenza Viral Infections
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Infections and infestations
Klebsiella Infections
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Infections and infestations
Lower Respiratory Tract And Lung Infections
|
15.1%
74/489 • Number of events 95 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
16.7%
25/150 • Number of events 26 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
11.3%
44/390 • Number of events 48 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
10.1%
36/357 • Number of events 43 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Infections and infestations
Pseudomonal Infections
|
0.20%
1/489 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.56%
2/357 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Infections and infestations
Sepsis, Bacteraemia, Viraemia And Fungaemia Nec
|
6.5%
32/489 • Number of events 35 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
11.3%
17/150 • Number of events 18 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
8.2%
32/390 • Number of events 38 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
8.1%
29/357 • Number of events 36 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Infections and infestations
Staphylococcal Infections
|
0.61%
3/489 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.7%
4/150 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.77%
3/390 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.84%
3/357 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Infections and infestations
Streptococcal Infections
|
0.41%
2/489 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.0%
3/150 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.51%
2/390 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Infections and infestations
Upper Respiratory Tract Infections
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
2/150 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.51%
2/390 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Infections and infestations
Urinary Tract Infections
|
5.7%
28/489 • Number of events 32 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
6.0%
9/150 • Number of events 11 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
5.4%
21/390 • Number of events 21 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
5.6%
20/357 • Number of events 22 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Infections and infestations
Vascular Infections
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Infections and infestations
Viral Infections Nec
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Injury, poisoning and procedural complications
Anaesthetic Complications
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Injury, poisoning and procedural complications
Cardiac And Vascular Procedural Complications
|
3.3%
16/489 • Number of events 17 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.0%
3/150 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.8%
7/390 • Number of events 7 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.84%
3/357 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Injury, poisoning and procedural complications
Cardiovascular Injuries
|
0.61%
3/489 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
2/150 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.56%
2/357 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Injury, poisoning and procedural complications
Cerebral Injuries Nec
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
2/150 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
5/390 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.56%
2/357 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Injury, poisoning and procedural complications
Chest And Lung Injuries Nec
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Injury, poisoning and procedural complications
Fractures And Dislocations Nec
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
2/150 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.84%
3/357 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Injury, poisoning and procedural complications
Gastrointestinal And Hepatobiliary Procedural Complications
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.56%
2/357 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Injury, poisoning and procedural complications
Limb Injuries Nec (Incl Traumatic Amputation)
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Injury, poisoning and procedural complications
Lower Limb Fractures And Dislocations
|
3.7%
18/489 • Number of events 19 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.3%
9/390 • Number of events 10 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.8%
10/357 • Number of events 12 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Injury, poisoning and procedural complications
Non-Site Specific Injuries Nec
|
2.7%
13/489 • Number of events 13 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.7%
4/150 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
3.6%
14/390 • Number of events 16 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.7%
6/357 • Number of events 6 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Injury, poisoning and procedural complications
Non-Site Specific Procedural Complications
|
5.1%
25/489 • Number of events 27 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
4.0%
6/150 • Number of events 6 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
6.4%
25/390 • Number of events 26 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
7.8%
28/357 • Number of events 29 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Injury, poisoning and procedural complications
Pelvic Fractures And Dislocations
|
0.82%
4/489 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
2/150 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.51%
2/390 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Injury, poisoning and procedural complications
Poisoning And Toxicity
|
0.41%
2/489 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Injury, poisoning and procedural complications
Radiation Injuries
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Injury, poisoning and procedural complications
Reproductive System And Breast Injuries
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Injury, poisoning and procedural complications
Respiratory Tract And Thoracic Cavity Procedural Complications
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.84%
3/357 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Injury, poisoning and procedural complications
Site Specific Injuries Nec
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.77%
3/390 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Injury, poisoning and procedural complications
Skin Injuries Nec
|
2.0%
10/489 • Number of events 11 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
5/390 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.4%
5/357 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Injury, poisoning and procedural complications
Skin Procedural Complications
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Injury, poisoning and procedural complications
Skull Fractures, Facial Bone Fractures And Dislocations
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Injury, poisoning and procedural complications
Spinal Fractures And Dislocations
|
1.2%
6/489 • Number of events 7 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
5/390 • Number of events 8 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.56%
2/357 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Injury, poisoning and procedural complications
Thoracic Cage Fractures And Dislocations
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Injury, poisoning and procedural complications
Transfusion Related Complications
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Injury, poisoning and procedural complications
Upper Limb Fractures And Dislocations
|
2.0%
10/489 • Number of events 11 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.51%
2/390 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.4%
5/357 • Number of events 6 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Investigations
Bacteria Identification And Serology (Excl Mycobacteria)
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Investigations
Blood Counts Nec
|
0.41%
2/489 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
2/150 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Investigations
Blood Gas And Acid Base Analyses
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.77%
3/390 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Investigations
Carbohydrate Tolerance Analyses (Incl Diabetes)
|
0.41%
2/489 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Investigations
Cardiac Function Diagnostic Procedures
|
0.41%
2/489 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.0%
3/150 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.7%
6/357 • Number of events 6 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Investigations
Coagulation And Bleeding Analyses
|
1.0%
5/489 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
2/150 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.5%
6/390 • Number of events 6 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.7%
6/357 • Number of events 7 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Investigations
Ecg Investigations
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.51%
2/390 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Investigations
Liver Function Analyses
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Investigations
Metabolism Tests Nec
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Investigations
Microbiology And Serology Tests Nec
|
0.41%
2/489 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Investigations
Mineral And Electrolyte Analyses
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Investigations
Physical Examination Procedures
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.51%
2/390 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.56%
2/357 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Investigations
Platelet Analyses
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Investigations
Protein Analyses Nec
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Investigations
Red Blood Cell Analyses
|
2.7%
13/489 • Number of events 13 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.7%
4/150 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.6%
10/390 • Number of events 10 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
3.1%
11/357 • Number of events 11 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Investigations
Renal Function Analyses
|
0.82%
4/489 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.51%
2/390 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Investigations
Respiratory Tract And Thoracic Imaging Procedures
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Investigations
Skeletal And Cardiac Muscle Analyses
|
0.82%
4/489 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
2/150 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.4%
5/357 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Investigations
Tissue Enzyme Analyses Nec
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Investigations
Urinalysis Nec
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Investigations
Urinary Tract Function Analyses Nec
|
0.61%
3/489 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
2/150 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.84%
3/357 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Investigations
Vascular Tests Nec (Incl Blood Pressure)
|
0.61%
3/489 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Investigations
White Blood Cell Analyses
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Metabolism and nutrition disorders
Appetite Disorders
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.56%
2/357 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Metabolism and nutrition disorders
Calcium Metabolism Disorders
|
0.41%
2/489 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.51%
2/390 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus (Incl Subtypes)
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Metabolism and nutrition disorders
Diabetic Complications Dermal
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Metabolism and nutrition disorders
Diabetic Complications Nec
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Metabolism and nutrition disorders
Disorders Of Purine Metabolism
|
0.61%
3/489 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.51%
2/390 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance Nec
|
1.0%
5/489 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Metabolism and nutrition disorders
General Nutritional Disorders Nec
|
3.7%
18/489 • Number of events 20 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
4.7%
7/150 • Number of events 7 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.0%
4/390 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
4.2%
15/357 • Number of events 16 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemic Conditions Nec
|
0.82%
4/489 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.77%
3/390 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.7%
6/357 • Number of events 6 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Metabolism and nutrition disorders
Hypoglycaemic Conditions Nec
|
0.82%
4/489 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
3.3%
5/150 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.77%
3/390 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.1%
4/357 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Metabolism and nutrition disorders
Magnesium Metabolism Disorders
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Metabolism and nutrition disorders
Metabolic Acidoses (Excl Diabetic Acidoses)
|
0.61%
3/489 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.0%
3/150 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.1%
4/357 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Metabolism and nutrition disorders
Metabolic Alkaloses
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Metabolism and nutrition disorders
Mixed Acid-Base Disorders
|
0.41%
2/489 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.77%
3/390 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Metabolism and nutrition disorders
Potassium Imbalance
|
2.9%
14/489 • Number of events 15 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
2/150 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.1%
8/390 • Number of events 8 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.4%
5/357 • Number of events 6 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Metabolism and nutrition disorders
Protein Metabolism Disorders Nec
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Metabolism and nutrition disorders
Sodium Imbalance
|
1.6%
8/489 • Number of events 10 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
2/150 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
5/390 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.4%
5/357 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Metabolism and nutrition disorders
Total Fluid Volume Decreased
|
3.1%
15/489 • Number of events 15 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
5.3%
8/150 • Number of events 8 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.1%
8/390 • Number of events 9 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
3.9%
14/357 • Number of events 15 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Metabolism and nutrition disorders
Total Fluid Volume Increased
|
2.5%
12/489 • Number of events 13 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.8%
7/390 • Number of events 7 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
3.1%
11/357 • Number of events 12 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Musculoskeletal and connective tissue disorders
Arthropathies Nec
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.51%
2/390 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Musculoskeletal and connective tissue disorders
Bone Disorders Nec
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Musculoskeletal and connective tissue disorders
Bone Related Signs And Symptoms
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Musculoskeletal and connective tissue disorders
Joint Related Signs And Symptoms
|
0.41%
2/489 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.77%
3/390 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Musculoskeletal and connective tissue disorders
Metabolic Bone Disorders
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Conditions
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.0%
3/150 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.84%
3/357 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal And Connective Tissue Pain And Discomfort
|
1.6%
8/489 • Number of events 9 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
3.3%
13/390 • Number of events 15 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.0%
7/357 • Number of events 7 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal And Connective Tissue Signs And Symptoms Nec
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Musculoskeletal and connective tissue disorders
Myopathies
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.84%
3/357 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthropathies
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
2/150 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.77%
3/390 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Musculoskeletal and connective tissue disorders
Spine And Neck Deformities
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-Cell Lymphomas Nec
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.51%
2/390 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Neoplasms Malignant
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast And Nipple Neoplasms Malignant
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colonic Neoplasms Malignant
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Neoplasms Malignant
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Neoplasms Malignant
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemias Acute Myeloid
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple Myelomas
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic Syndromes
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Malignant Site Unspecified Nec
|
0.61%
3/489 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.51%
2/390 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.56%
2/357 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuromas
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Neoplasms Malignant (Excl Islet Cell And Carcinoid)
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.51%
2/390 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pharyngeal And Laryngeal Neoplasms Benign
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic Neoplasms Malignant
|
0.61%
3/489 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Neoplasms Malignant
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Respiratory Tract And Pleural Neoplasms Malignant Cell Type Unspecified Nec
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
2/150 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Neoplasms Malignant And Unspecified (Excl Melanoma)
|
0.41%
2/489 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.51%
2/390 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.56%
2/357 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid Neoplasms Malignant
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Nervous system disorders
Acute Polyneuropathies
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Nervous system disorders
Central Nervous System Haemorrhages And Cerebrovascular Accidents
|
5.7%
28/489 • Number of events 28 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
9.3%
14/150 • Number of events 14 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
6.7%
26/390 • Number of events 30 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
9.0%
32/357 • Number of events 35 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Nervous system disorders
Central Nervous System Vascular Disorders Nec
|
0.41%
2/489 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.77%
3/390 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Nervous system disorders
Cerebellar Coordination And Balance Disturbances
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Nervous system disorders
Coma States
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Nervous system disorders
Cortical Dysfunction Nec
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Nervous system disorders
Dementia (Excl Alzheimer's Type)
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Nervous system disorders
Disturbances In Consciousness Nec
|
1.8%
9/489 • Number of events 9 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.7%
4/150 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
3.6%
14/390 • Number of events 15 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.0%
7/357 • Number of events 8 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Nervous system disorders
Dyskinesias And Movement Disorders Nec
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Nervous system disorders
Encephalopathies Nec
|
2.9%
14/489 • Number of events 14 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.0%
4/390 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.4%
5/357 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Nervous system disorders
Encephalopathies Toxic And Metabolic
|
1.6%
8/489 • Number of events 11 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.77%
3/390 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.56%
2/357 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Nervous system disorders
Headaches Nec
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
2/150 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Nervous system disorders
Hydrocephalic Conditions
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Nervous system disorders
Increased Intracranial Pressure Disorders
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Nervous system disorders
Lumbar Spinal Cord And Nerve Root Disorders
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Nervous system disorders
Memory Loss (Excl Dementia)
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Nervous system disorders
Migraine Headaches
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Nervous system disorders
Mononeuropathies
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.56%
2/357 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Nervous system disorders
Nervous System Disorders Nec
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Nervous system disorders
Neurological Signs And Symptoms Nec
|
1.4%
7/489 • Number of events 8 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
5.3%
8/150 • Number of events 8 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.51%
2/390 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
3.1%
11/357 • Number of events 11 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Nervous system disorders
Neuromuscular Junction Dysfunction
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Nervous system disorders
Paralysis And Paresis (Excl Cranial Nerve)
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.56%
2/357 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Nervous system disorders
Peripheral Neuropathies Nec
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Nervous system disorders
Seizures And Seizure Disorders Nec
|
0.61%
3/489 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.0%
3/150 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.8%
10/357 • Number of events 10 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Nervous system disorders
Sensory Abnormalities Nec
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Nervous system disorders
Speech And Language Abnormalities
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Nervous system disorders
Transient Cerebrovascular Events
|
1.4%
7/489 • Number of events 8 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.5%
6/390 • Number of events 6 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.56%
2/357 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Nervous system disorders
Tremor (Excl Congenital)
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Nervous system disorders
Vagus Nerve Disorders
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Psychiatric disorders
Anxiety Symptoms
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.51%
2/390 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Psychiatric disorders
Behaviour And Socialisation Disturbances
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Psychiatric disorders
Confusion And Disorientation
|
1.2%
6/489 • Number of events 6 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.1%
8/390 • Number of events 9 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.1%
4/357 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Psychiatric disorders
Deliria
|
0.61%
3/489 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.0%
4/390 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Psychiatric disorders
Depressive Disorders
|
0.61%
3/489 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.51%
2/390 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.56%
2/357 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Psychiatric disorders
Mental Disorders Nec
|
2.7%
13/489 • Number of events 13 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.0%
3/150 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.0%
4/390 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
3.9%
14/357 • Number of events 14 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Psychiatric disorders
Perception Disturbances
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.51%
2/390 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Psychiatric disorders
Suicidal And Self-Injurious Behaviour
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Renal and urinary disorders
Bladder And Urethral Symptoms
|
1.4%
7/489 • Number of events 7 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
5.3%
8/150 • Number of events 9 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.1%
8/390 • Number of events 9 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.5%
9/357 • Number of events 11 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Renal and urinary disorders
Bladder Disorders Nec
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.0%
3/150 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.56%
2/357 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Renal and urinary disorders
Genital And Urinary Tract Disorders Nec
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Renal and urinary disorders
Nephritis Nec
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Renal and urinary disorders
Nephropathies And Tubular Disorders Nec
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Renal and urinary disorders
Renal Disorders Nec
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Renal and urinary disorders
Renal Failure And Impairment
|
18.4%
90/489 • Number of events 108 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
20.7%
31/150 • Number of events 43 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
9.7%
38/390 • Number of events 42 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
16.2%
58/357 • Number of events 66 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Renal and urinary disorders
Renal Failure Complications
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Renal and urinary disorders
Renal Lithiasis
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Renal and urinary disorders
Renal Obstructive Disorders
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Renal and urinary disorders
Renal Vascular And Ischaemic Conditions
|
0.41%
2/489 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.56%
2/357 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Renal and urinary disorders
Ureteric Disorders Nec
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Renal and urinary disorders
Urinary Abnormalities
|
2.0%
10/489 • Number of events 13 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.1%
8/390 • Number of events 8 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.7%
6/357 • Number of events 11 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Reproductive system and breast disorders
Breast Disorders Nec
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Reproductive system and breast disorders
Pelvic Prolapse Conditions
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Reproductive system and breast disorders
Prostatic Neoplasms And Hypertrophy
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Reproductive system and breast disorders
Reproductive Tract Disorders Nec (Excl Neoplasms)
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Reproductive system and breast disorders
Scrotal Disorders Nec
|
0.41%
2/489 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Reproductive system and breast disorders
Vulvovaginal Disorders Nec
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Breathing Abnormalities
|
5.3%
26/489 • Number of events 27 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
14.0%
21/150 • Number of events 29 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
7.7%
30/390 • Number of events 33 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
7.3%
26/357 • Number of events 31 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Conditions Nec
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm And Obstruction
|
5.1%
25/489 • Number of events 28 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
10.7%
16/150 • Number of events 21 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
3.3%
13/390 • Number of events 15 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.2%
8/357 • Number of events 9 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Conditions Associated With Abnormal Gas Exchange
|
1.4%
7/489 • Number of events 7 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.5%
6/390 • Number of events 6 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.7%
6/357 • Number of events 6 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Coughing And Associated Symptoms
|
0.41%
2/489 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
5/390 • Number of events 6 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic Disorders
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
2/150 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal And Adjacent Sites Disorders Nec (Excl Infections And Neoplasms)
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Spasm, Oedema And Obstruction
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Lower Respiratory Tract Inflammatory And Immunologic Conditions
|
1.6%
8/489 • Number of events 9 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
4.0%
6/150 • Number of events 6 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.8%
7/390 • Number of events 7 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.2%
8/357 • Number of events 8 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Lower Respiratory Tract Signs And Symptoms
|
0.41%
2/489 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal Disorders
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
2/150 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.84%
3/357 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Disorders Nec
|
0.82%
4/489 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
5/390 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Parenchymal Lung Disorders Nec
|
1.2%
6/489 • Number of events 6 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.0%
3/150 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.77%
3/390 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.1%
4/357 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Disorders (Excl Infections And Neoplasms)
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax And Pleural Effusions Nec
|
11.0%
54/489 • Number of events 74 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
17.3%
26/150 • Number of events 36 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
7.4%
29/390 • Number of events 39 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
18.8%
67/357 • Number of events 86 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertensions
|
0.41%
2/489 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
5/390 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedemas
|
4.7%
23/489 • Number of events 24 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.0%
3/150 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.3%
9/390 • Number of events 9 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.8%
10/357 • Number of events 10 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Thrombotic And Embolic Conditions
|
1.4%
7/489 • Number of events 7 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failures (Excl Neonatal)
|
11.0%
54/489 • Number of events 62 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
18.7%
28/150 • Number of events 29 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
9.2%
36/390 • Number of events 40 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
15.1%
54/357 • Number of events 68 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Disorders Nec
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.77%
3/390 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.56%
2/357 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal Disorders (Excl Infections And Neoplasms)
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Signs And Symptoms
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Skin and subcutaneous tissue disorders
Bullous Conditions
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.51%
2/390 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Skin and subcutaneous tissue disorders
Dermal And Epidermal Conditions Nec
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Skin and subcutaneous tissue disorders
Dermatitis And Eczema
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.56%
2/357 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Ascribed To Specific Agent
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Skin and subcutaneous tissue disorders
Purpura And Related Conditions
|
0.41%
2/489 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Skin and subcutaneous tissue disorders
Rashes, Eruptions And Exanthems Nec
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Ulcerations
|
0.61%
3/489 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Skin and subcutaneous tissue disorders
Skin Haemorrhages
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Skin and subcutaneous tissue disorders
Skin Injuries And Mechanical Dermatoses
|
0.41%
2/489 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.5%
6/390 • Number of events 6 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.1%
4/357 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Skin and subcutaneous tissue disorders
Skin Preneoplastic Conditions Nec
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Social circumstances
Housing Circumstances
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Surgical and medical procedures
Cardiac Device Therapeutic Procedures
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Surgical and medical procedures
Corneal And Scleral Therapeutic Procedures
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Surgical and medical procedures
Fracture Treatments (Excl Skull And Spine)
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Surgical and medical procedures
Hernia Repairs
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Surgical and medical procedures
Joint Therapeutic Procedures
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Surgical and medical procedures
Lens Therapeutic Procedures
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.51%
2/390 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Surgical and medical procedures
Limb Therapeutic Procedures
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Surgical and medical procedures
Muscle Therapeutic Procedures
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Surgical and medical procedures
Prophylactic Procedures Nec
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Surgical and medical procedures
Renal Therapeutic Procedures
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Surgical and medical procedures
Therapeutic Procedures Nec
|
1.8%
9/489 • Number of events 9 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.77%
3/390 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.56%
2/357 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Surgical and medical procedures
Tracheal Therapeutic Procedures
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Surgical and medical procedures
Ureteric Therapeutic Procedures
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Vascular disorders
Accelerated And Malignant Hypertension
|
0.41%
2/489 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
2/150 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Vascular disorders
Aneurysms And Dissections Non-Site Specific
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
3.3%
5/150 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Vascular disorders
Aortic Aneurysms And Dissections
|
0.82%
4/489 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.0%
3/150 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.4%
5/357 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Vascular disorders
Aortic Necrosis And Vascular Insufficiency
|
0.00%
0/489 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Vascular disorders
Arterial And Aortic Injuries
|
0.41%
2/489 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Vascular disorders
Blood Pressure Disorders Nec
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.56%
2/357 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Vascular disorders
Circulatory Collapse And Shock
|
1.2%
6/489 • Number of events 7 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
2/150 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.51%
2/390 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.1%
4/357 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Vascular disorders
Haemorrhages Nec
|
4.1%
20/489 • Number of events 24 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
8.7%
13/150 • Number of events 13 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
4.9%
19/390 • Number of events 19 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.8%
10/357 • Number of events 11 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Vascular disorders
Lymphangiopathies
|
0.41%
2/489 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.51%
2/390 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Vascular disorders
Lymphoedemas
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Vascular disorders
Non-Site Specific Embolism And Thrombosis
|
1.2%
6/489 • Number of events 7 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.26%
1/390 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.56%
2/357 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Vascular disorders
Non-Site Specific Necrosis And Vascular Insufficiency Nec
|
0.61%
3/489 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
2/150 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.77%
3/390 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.84%
3/357 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Vascular disorders
Non-Site Specific Vascular Disorders Nec
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.51%
2/390 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Vascular disorders
Peripheral Aneurysms And Dissections
|
1.0%
5/489 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.3%
9/390 • Number of events 9 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.28%
1/357 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Vascular disorders
Peripheral Embolism And Thrombosis
|
4.3%
21/489 • Number of events 22 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
3.3%
5/150 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.8%
7/390 • Number of events 7 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.4%
5/357 • Number of events 6 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Vascular disorders
Peripheral Vascular Disorders Nec
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.51%
2/390 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Vascular disorders
Peripheral Vasoconstriction, Necrosis And Vascular Insufficiency
|
3.3%
16/489 • Number of events 18 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
2/150 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
3.1%
12/390 • Number of events 12 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.56%
2/357 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Vascular disorders
Site Specific Vascular Disorders Nec
|
0.61%
3/489 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.67%
1/150 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.7%
6/357 • Number of events 7 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Vascular disorders
Varicose Veins Non-Site Specific
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Vascular disorders
Vascular Hypertensive Disorders Nec
|
2.2%
11/489 • Number of events 11 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.0%
3/150 • Number of events 3 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
3.6%
14/390 • Number of events 15 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.0%
7/357 • Number of events 7 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Vascular disorders
Vascular Hypotensive Disorders
|
10.6%
52/489 • Number of events 54 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
10.0%
15/150 • Number of events 15 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
5.4%
21/390 • Number of events 23 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
10.6%
38/357 • Number of events 40 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Vascular disorders
Vascular Malformations And Acquired Anomalies
|
0.20%
1/489 • Number of events 1 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/150 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/390 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
0.00%
0/357 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
Other adverse events
| Measure |
Extreme Risk: TAVI Iliofemoral
n=489 participants at risk
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
|
Extreme Risk: TAVI Non-Iliofemoral
n=150 participants at risk
Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
|
High Risk: TAVI
n=390 participants at risk
High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
|
High Risk: SAVR
n=357 participants at risk
High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Breathing Abnormalities
|
5.3%
26/489 • Number of events 26 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
5.3%
8/150 • Number of events 8 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
6.9%
27/390 • Number of events 29 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
3.9%
14/357 • Number of events 16 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm And Obstruction
|
1.4%
7/489 • Number of events 7 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
6.7%
10/150 • Number of events 11 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.0%
4/390 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.8%
10/357 • Number of events 10 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Blood and lymphatic system disorders
Anaemias Nec
|
18.4%
90/489 • Number of events 98 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
18.0%
27/150 • Number of events 28 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
19.5%
76/390 • Number of events 77 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
19.3%
69/357 • Number of events 78 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Blood and lymphatic system disorders
Leukocytoses Nec
|
7.8%
38/489 • Number of events 42 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
12.0%
18/150 • Number of events 19 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
6.4%
25/390 • Number of events 26 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
12.9%
46/357 • Number of events 49 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenias
|
13.9%
68/489 • Number of events 73 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
21.3%
32/150 • Number of events 33 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
15.6%
61/390 • Number of events 64 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
25.2%
90/357 • Number of events 95 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Cardiac disorders
Cardiac Conduction Disorders
|
23.3%
114/489 • Number of events 137 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
21.3%
32/150 • Number of events 37 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
20.5%
80/390 • Number of events 100 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
15.1%
54/357 • Number of events 68 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Cardiac disorders
Heart Failures Nec
|
6.1%
30/489 • Number of events 32 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
6.0%
9/150 • Number of events 9 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
5.1%
20/390 • Number of events 22 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
5.9%
21/357 • Number of events 24 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Cardiac disorders
Rate And Rhythm Disorders Nec
|
5.9%
29/489 • Number of events 30 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
8.0%
12/150 • Number of events 13 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
5.4%
21/390 • Number of events 22 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
8.4%
30/357 • Number of events 31 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Cardiac disorders
Supraventricular Arrhythmias
|
12.3%
60/489 • Number of events 66 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
24.0%
36/150 • Number of events 42 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
15.1%
59/390 • Number of events 69 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
22.4%
80/357 • Number of events 91 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Cardiac disorders
Ventricular Arrhythmias And Cardiac Arrest
|
6.3%
31/489 • Number of events 33 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
5.3%
8/150 • Number of events 10 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
5.6%
22/390 • Number of events 22 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.5%
9/357 • Number of events 9 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Gastrointestinal Atonic And Hypomotility Disorders Nec
|
7.4%
36/489 • Number of events 37 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
8.0%
12/150 • Number of events 12 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
5.6%
22/390 • Number of events 22 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
6.7%
24/357 • Number of events 24 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Gastrointestinal disorders
Nausea And Vomiting Symptoms
|
5.3%
26/489 • Number of events 33 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
4.7%
7/150 • Number of events 7 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
5.9%
23/390 • Number of events 25 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
4.5%
16/357 • Number of events 21 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
General disorders
Febrile Disorders
|
7.4%
36/489 • Number of events 39 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
4.7%
7/150 • Number of events 8 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
4.1%
16/390 • Number of events 16 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
4.5%
16/357 • Number of events 16 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
General disorders
Oedema Nec
|
9.0%
44/489 • Number of events 48 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
10.7%
16/150 • Number of events 18 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
8.7%
34/390 • Number of events 35 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
7.3%
26/357 • Number of events 31 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
General disorders
Pain And Discomfort Nec
|
6.1%
30/489 • Number of events 34 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
6.0%
9/150 • Number of events 10 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
6.7%
26/390 • Number of events 30 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
8.4%
30/357 • Number of events 33 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Infections and infestations
Lower Respiratory Tract And Lung Infections
|
5.3%
26/489 • Number of events 26 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
10.7%
16/150 • Number of events 16 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
4.6%
18/390 • Number of events 19 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
5.9%
21/357 • Number of events 23 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Infections and infestations
Urinary Tract Infections
|
15.3%
75/489 • Number of events 80 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
18.7%
28/150 • Number of events 34 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
13.1%
51/390 • Number of events 59 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
16.2%
58/357 • Number of events 67 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Injury, poisoning and procedural complications
Non-Site Specific Injuries Nec
|
5.1%
25/489 • Number of events 26 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
2/150 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
5.4%
21/390 • Number of events 23 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
3.1%
11/357 • Number of events 15 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Injury, poisoning and procedural complications
Non-Site Specific Procedural Complications
|
4.3%
21/489 • Number of events 23 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
4.0%
6/150 • Number of events 6 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
5.1%
20/390 • Number of events 21 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
8.1%
29/357 • Number of events 29 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Investigations
Skeletal And Cardiac Muscle Analyses
|
3.3%
16/489 • Number of events 16 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
4.7%
7/150 • Number of events 7 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
3.8%
15/390 • Number of events 15 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
5.3%
19/357 • Number of events 19 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemic Conditions Nec
|
4.5%
22/489 • Number of events 22 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
4.0%
6/150 • Number of events 6 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
4.9%
19/390 • Number of events 19 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
8.1%
29/357 • Number of events 30 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Metabolism and nutrition disorders
Magnesium Metabolism Disorders
|
3.5%
17/489 • Number of events 17 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
6.0%
9/150 • Number of events 10 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.5%
6/390 • Number of events 6 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.5%
9/357 • Number of events 9 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Metabolism and nutrition disorders
Potassium Imbalance
|
11.5%
56/489 • Number of events 63 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
10.7%
16/150 • Number of events 25 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
9.2%
36/390 • Number of events 38 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
9.2%
33/357 • Number of events 37 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Metabolism and nutrition disorders
Sodium Imbalance
|
5.1%
25/489 • Number of events 26 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
6.7%
10/150 • Number of events 13 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
5.6%
22/390 • Number of events 22 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
7.8%
28/357 • Number of events 29 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Metabolism and nutrition disorders
Total Fluid Volume Increased
|
4.1%
20/489 • Number of events 20 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
8.0%
12/150 • Number of events 13 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
5.4%
21/390 • Number of events 21 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
11.5%
41/357 • Number of events 43 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal And Connective Tissue Pain And Discomfort
|
7.0%
34/489 • Number of events 42 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
10.7%
16/150 • Number of events 19 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
8.7%
34/390 • Number of events 39 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
6.2%
22/357 • Number of events 22 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Nervous system disorders
Neurological Signs And Symptoms Nec
|
3.7%
18/489 • Number of events 20 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
1.3%
2/150 • Number of events 2 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
5.4%
21/390 • Number of events 22 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
4.8%
17/357 • Number of events 21 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Psychiatric disorders
Anxiety Symptoms
|
5.1%
25/489 • Number of events 25 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
4.0%
6/150 • Number of events 6 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
3.6%
14/390 • Number of events 14 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
3.9%
14/357 • Number of events 14 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Psychiatric disorders
Confusion And Disorientation
|
6.5%
32/489 • Number of events 34 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
8.7%
13/150 • Number of events 14 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
6.2%
24/390 • Number of events 25 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
6.4%
23/357 • Number of events 25 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Renal and urinary disorders
Renal Failure And Impairment
|
13.7%
67/489 • Number of events 78 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
10.7%
16/150 • Number of events 20 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
10.3%
40/390 • Number of events 43 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
12.3%
44/357 • Number of events 51 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Conditions Associated With Abnormal Gas Exchange
|
2.5%
12/489 • Number of events 12 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
5.3%
8/150 • Number of events 11 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.8%
11/390 • Number of events 12 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
3.1%
11/357 • Number of events 11 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Parenchymal Lung Disorders Nec
|
7.2%
35/489 • Number of events 35 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
6.7%
10/150 • Number of events 10 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
5.9%
23/390 • Number of events 23 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
11.5%
41/357 • Number of events 41 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Reproductive system and breast disorders
Pneumothorax And Pleural Effusions Nec
|
15.5%
76/489 • Number of events 82 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
20.0%
30/150 • Number of events 32 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
13.3%
52/390 • Number of events 58 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
25.5%
91/357 • Number of events 105 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedemas
|
5.9%
29/489 • Number of events 29 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
3.3%
5/150 • Number of events 5 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
5.1%
20/390 • Number of events 20 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
7.3%
26/357 • Number of events 27 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Vascular disorders
Haemorrhages Nec
|
7.0%
34/489 • Number of events 35 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.7%
4/150 • Number of events 4 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
6.7%
26/390 • Number of events 26 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
2.5%
9/357 • Number of events 9 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Vascular disorders
Vascular Hypertensive Disorders Nec
|
9.2%
45/489 • Number of events 49 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
13.3%
20/150 • Number of events 20 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
11.8%
46/390 • Number of events 55 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
10.4%
37/357 • Number of events 40 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
|
Vascular disorders
Vascular Hypotensive Disorders
|
13.9%
68/489 • Number of events 73 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
12.0%
18/150 • Number of events 21 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
10.3%
40/390 • Number of events 41 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
11.2%
40/357 • Number of events 43 • Adverse events (AEs) were collected from study enrollment to study closure, up to 5 years. Adverse event data are currently available and reported for up to 1 year
All new or worsening AEs were collected through12 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60