Trial Outcomes & Findings for Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions (NCT NCT02389946)
NCT ID: NCT02389946
Last Updated: 2022-08-03
Results Overview
TLF is defined as all cardiac death, target vessel Q-wave or non-Q-wave myocardial infarction (MI), or clinically driven target lesion revascularization (TLR).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1334 participants
Primary outcome timeframe
12-Months
Results posted on
2022-08-03
Participant Flow
Participant milestones
| Measure |
Orsiro Sirolimus Coronary Stent System
Intervention with a Orsiro DES.
Orsiro DES: Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.
|
Xience Everolimus Coronary Stent System
Intervention with a Xience DES.
Xience DES
|
|---|---|---|
|
Overall Study
STARTED
|
884
|
450
|
|
Overall Study
COMPLETED
|
860
|
435
|
|
Overall Study
NOT COMPLETED
|
24
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
Baseline characteristics by cohort
| Measure |
Orsiro Sirolimus Coronary Stent System
n=884 Participants
Intervention with a Orsiro DES.
Orsiro DES: Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.
|
Xience Everolimus Coronary Stent System
n=450 Participants
Intervention with a Xience DES.
Xience DES
|
Total
n=1334 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.5 years
STANDARD_DEVIATION 10.32 • n=5 Participants
|
64.6 years
STANDARD_DEVIATION 10.67 • n=7 Participants
|
64.5 years
STANDARD_DEVIATION 10.44 • n=5 Participants
|
|
Sex: Female, Male
Female
|
224 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
346 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
660 Participants
n=5 Participants
|
328 Participants
n=7 Participants
|
988 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
35 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
812 Participants
n=5 Participants
|
417 Participants
n=7 Participants
|
1229 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
37 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
29 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
792 Participants
n=5 Participants
|
406 Participants
n=7 Participants
|
1198 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
27 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12-MonthsPopulation: Pre-specified Bayesian analysis: BIOFLOW-V intent-to-treat subjects who experienced the primary endpoint or had at least 330 days of follow-up and BIOFLOW-II (NCT01356888) and BIOFLOW-IV (NCT01939249) subjects who satisfied the BIOFLOW-V inclusion/exclusion criteria and experienced the primary endpoint or had at least 330 days of follow-up.
TLF is defined as all cardiac death, target vessel Q-wave or non-Q-wave myocardial infarction (MI), or clinically driven target lesion revascularization (TLR).
Outcome measures
| Measure |
Orsiro Sirolimus Coronary Stent System
n=883 Participants
Intervention with a Orsiro DES.
Orsiro DES: Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.
|
Xience Everolimus Coronary Stent System
n=427 Participants
Intervention with a Xience DES.
Xience DES
|
|---|---|---|
|
Percentage of Participants With Target Lesion Failure (TLF) at 12 Months Post-Index Procedure by Bayesian Estimation
|
6.32 Percentage of participants
Standard Deviation 0.75
|
8.90 Percentage of participants
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: Hospital Discharge (6-24 hours post-index procedure)Population: Device Success per lesion. Lesions that were not treated and lesions missing both site-reported and core lab-assessed percent residual stenosis were excluded from the analysis.
Defined as attainment of \< 30% residual stenosis of the target lesion using the assigned study stent only.
Outcome measures
| Measure |
Orsiro Sirolimus Coronary Stent System
n=1107 Lesions
Intervention with a Orsiro DES.
Orsiro DES: Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.
|
Xience Everolimus Coronary Stent System
n=583 Lesions
Intervention with a Xience DES.
Xience DES
|
|---|---|---|
|
Number of Lesions With Device Success
|
1082 Lesions
|
566 Lesions
|
SECONDARY outcome
Timeframe: Hospital Discharge (6-24 hours post-index procedure)Population: Lesion Success per lesion. Lesions that were not treated and lesions missing both site-reported and core lab-assessed percent residual stenosis were excluded from the analysis.
Defined as attainment of \< 30% residual stenosis of the target lesion using any percutaneous method.
Outcome measures
| Measure |
Orsiro Sirolimus Coronary Stent System
n=1107 Lesions
Intervention with a Orsiro DES.
Orsiro DES: Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.
|
Xience Everolimus Coronary Stent System
n=583 Lesions
Intervention with a Xience DES.
Xience DES
|
|---|---|---|
|
Number of Lesions With Lesion Success
|
1102 Lesions
|
579 Lesions
|
SECONDARY outcome
Timeframe: Hospital Discharge (6-24 hours post-index procedure)Population: Procedure success was analyzed per subject: for a subject to be considered a procedure success, all of the subject's target lesions had to be considered device success. Lesions that were not treated and lesions missing both site-reported and core lab-assessed percent residual stenosis were excluded from the analysis.
Defined as attainment of \< 30% residual stenosis of the target lesion using the assigned study stent only without occurrence of in-hospital major adverse cardiac events (MACE; composite of all-cause death, Q-wave or non-Q-wave MI, and any clinically-driven TLR).
Outcome measures
| Measure |
Orsiro Sirolimus Coronary Stent System
n=881 Participants
Intervention with a Orsiro DES.
Orsiro DES: Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.
|
Xience Everolimus Coronary Stent System
n=445 Participants
Intervention with a Xience DES.
Xience DES
|
|---|---|---|
|
Number of Participants With Procedure Success
|
827 Participants
|
401 Participants
|
SECONDARY outcome
Timeframe: Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 yearsPopulation: Analysis population for each outcome measure time frame is based on participants completing or experiencing an event at that time frame.
Outcome measures
| Measure |
Orsiro Sirolimus Coronary Stent System
n=882 Participants
Intervention with a Orsiro DES.
Orsiro DES: Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.
|
Xience Everolimus Coronary Stent System
n=449 Participants
Intervention with a Xience DES.
Xience DES
|
|---|---|---|
|
Number of Participants With Myocardial Infarction
6-month
|
40 Participants
|
36 Participants
|
|
Number of Participants With Myocardial Infarction
6-24 hours post-index procedure
|
34 Participants
|
30 Participants
|
|
Number of Participants With Myocardial Infarction
1-month post-index procedure
|
38 Participants
|
31 Participants
|
|
Number of Participants With Myocardial Infarction
12-month
|
41 Participants
|
37 Participants
|
|
Number of Participants With Myocardial Infarction
2-year
|
56 Participants
|
42 Participants
|
|
Number of Participants With Myocardial Infarction
3-year
|
60 Participants
|
49 Participants
|
|
Number of Participants With Myocardial Infarction
4-year
|
66 Participants
|
52 Participants
|
|
Number of Participants With Myocardial Infarction
5-year
|
76 Participants
|
58 Participants
|
SECONDARY outcome
Timeframe: Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 yearsPopulation: Analysis population for each outcome measure time frame is based on participants completing or experiencing an event at that time frame.
Outcome measures
| Measure |
Orsiro Sirolimus Coronary Stent System
n=883 Participants
Intervention with a Orsiro DES.
Orsiro DES: Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.
|
Xience Everolimus Coronary Stent System
n=449 Participants
Intervention with a Xience DES.
Xience DES
|
|---|---|---|
|
Number of Participants With Myocardial Infarction or Cardiac Death
Hospital Discharge (6-24 hours post-index procedure)
|
35 Participants
|
30 Participants
|
|
Number of Participants With Myocardial Infarction or Cardiac Death
1-month
|
39 Participants
|
31 Participants
|
|
Number of Participants With Myocardial Infarction or Cardiac Death
6-month
|
41 Participants
|
37 Participants
|
|
Number of Participants With Myocardial Infarction or Cardiac Death
12-month
|
42 Participants
|
39 Participants
|
|
Number of Participants With Myocardial Infarction or Cardiac Death
2-year
|
61 Participants
|
43 Participants
|
|
Number of Participants With Myocardial Infarction or Cardiac Death
3-year
|
68 Participants
|
51 Participants
|
|
Number of Participants With Myocardial Infarction or Cardiac Death
4-year
|
82 Participants
|
54 Participants
|
|
Number of Participants With Myocardial Infarction or Cardiac Death
5-year
|
94 Participants
|
61 Participants
|
SECONDARY outcome
Timeframe: Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 yearsPopulation: Analysis population for each outcome measure time frame is based on participants completing or experiencing an event at that time frame.
MACE events are defined as all-cause death, Q-wave or non-Q-wave MI, or any clinically-driven TLR. The number of participants with any MACE event is provided, as well as number of participants with each of the individual components.
Outcome measures
| Measure |
Orsiro Sirolimus Coronary Stent System
n=883 Participants
Intervention with a Orsiro DES.
Orsiro DES: Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.
|
Xience Everolimus Coronary Stent System
n=449 Participants
Intervention with a Xience DES.
Xience DES
|
|---|---|---|
|
Number of Participants With MACE and Individual MACE Components
6-24 hours post-index MACE Total
|
35 Participants
|
31 Participants
|
|
Number of Participants With MACE and Individual MACE Components
6-24 hours post-index MACE Component: Death
|
1 Participants
|
1 Participants
|
|
Number of Participants With MACE and Individual MACE Components
6-24 hours post-index MACE Component: Protocol defined Q-Wave or non-Q-wave MI
|
34 Participants
|
30 Participants
|
|
Number of Participants With MACE and Individual MACE Components
6-24 hours post-index MACE Component: Clinically-driven TLR
|
2 Participants
|
2 Participants
|
|
Number of Participants With MACE and Individual MACE Components
1-month MACE Total
|
39 Participants
|
32 Participants
|
|
Number of Participants With MACE and Individual MACE Components
1-month MACE Component: Death
|
1 Participants
|
1 Participants
|
|
Number of Participants With MACE and Individual MACE Components
1-month MACE Component: Protocol defined Q-Wave or non-Q-wave MI
|
38 Participants
|
31 Participants
|
|
Number of Participants With MACE and Individual MACE Components
1-month MACE Component: Clinically-driven TLR
|
4 Participants
|
3 Participants
|
|
Number of Participants With MACE and Individual MACE Components
6-month MACE Total
|
53 Participants
|
42 Participants
|
|
Number of Participants With MACE and Individual MACE Components
6-month MACE Component: Death
|
6 Participants
|
4 Participants
|
|
Number of Participants With MACE and Individual MACE Components
6-month MACE Component: Protocol-defined Q-Wave or non-Q-wave MI
|
40 Participants
|
36 Participants
|
|
Number of Participants With MACE and Individual MACE Components
6-month MACE Component: Clinically-driven TLR
|
13 Participants
|
8 Participants
|
|
Number of Participants With MACE and Individual MACE Components
12-month MACE Total
|
59 Participants
|
44 Participants
|
|
Number of Participants With MACE and Individual MACE Components
12-month MACE Component: Death
|
7 Participants
|
6 Participants
|
|
Number of Participants With MACE and Individual MACE Components
12-month MACE Component: Protocol-defined Q-Wave or non-Q-wave MI
|
41 Participants
|
37 Participants
|
|
Number of Participants With MACE and Individual MACE Components
12-month MACE Component: Clinically-driven TLR
|
17 Participants
|
10 Participants
|
|
Number of Participants With MACE and Individual MACE Components
2-year MACE Total
|
85 Participants
|
56 Participants
|
|
Number of Participants With MACE and Individual MACE Components
2-year MACE Component: Death
|
16 Participants
|
9 Participants
|
|
Number of Participants With MACE and Individual MACE Components
2-year MACE Component: Protocol-defined Q-Wave or non-Q-wave MI
|
56 Participants
|
42 Participants
|
|
Number of Participants With MACE and Individual MACE Components
2-year MACE Component: Clinically-driven TLR
|
21 Participants
|
19 Participants
|
|
Number of Participants With MACE and Individual MACE Components
3-year MACE Total
|
102 Participants
|
73 Participants
|
|
Number of Participants With MACE and Individual MACE Components
3-year MACE Component: Death
|
27 Participants
|
17 Participants
|
|
Number of Participants With MACE and Individual MACE Components
3-year MACE Component: Protocol-defined Q-Wave or non-Q-wave MI
|
60 Participants
|
49 Participants
|
|
Number of Participants With MACE and Individual MACE Components
3-year MACE Component: Clinically-driven TLR
|
27 Participants
|
25 Participants
|
|
Number of Participants With MACE and Individual MACE Components
4-year MACE Total
|
133 Participants
|
81 Participants
|
|
Number of Participants With MACE and Individual MACE Components
4-year MACE Component: Death
|
45 Participants
|
22 Participants
|
|
Number of Participants With MACE and Individual MACE Components
4-year MACE Component: Protocol-defined Q-Wave or non-Q-wave MI
|
66 Participants
|
52 Participants
|
|
Number of Participants With MACE and Individual MACE Components
4-year MACE Component: Clinically-driven TLR
|
38 Participants
|
28 Participants
|
|
Number of Participants With MACE and Individual MACE Components
5-year MACE Total
|
155 Participants
|
92 Participants
|
|
Number of Participants With MACE and Individual MACE Components
5-year MACE Component: Death
|
56 Participants
|
27 Participants
|
|
Number of Participants With MACE and Individual MACE Components
5-year MACE Component: Protocol-defined Q-Wave or non-Q-wave MI
|
76 Participants
|
58 Participants
|
|
Number of Participants With MACE and Individual MACE Components
5-year MACE Clinically-driven TLR
|
48 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 yearsPopulation: Analysis population for each outcome measure time frame is based on participants completing or experiencing an event at that time frame.
TLF events are defined as cardiac death, target vessel Q-wave or non-Q-wave MI, or any clinically-driven TLR. The number of participants with any TLF event is provided, as well as number of participants with each of the individual components.
Outcome measures
| Measure |
Orsiro Sirolimus Coronary Stent System
n=883 Participants
Intervention with a Orsiro DES.
Orsiro DES: Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.
|
Xience Everolimus Coronary Stent System
n=449 Participants
Intervention with a Xience DES.
Xience DES
|
|---|---|---|
|
Number of Participants With TLF and Individual TLF Components
2-year TLF Total
|
64 Participants
|
48 Participants
|
|
Number of Participants With TLF and Individual TLF Components
4-year TLF Total
|
91 Participants
|
60 Participants
|
|
Number of Participants With TLF and Individual TLF Components
4-year TLF Component: Cardiac Death
|
17 Participants
|
5 Participants
|
|
Number of Participants With TLF and Individual TLF Components
6-24 hours post-index TLF Total
|
35 Participants
|
31 Participants
|
|
Number of Participants With TLF and Individual TLF Components
6-24 hours post-index TLF Component: Cardiac Death
|
1 Participants
|
1 Participants
|
|
Number of Participants With TLF and Individual TLF Components
6-24 hours post-index TLF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI
|
34 Participants
|
29 Participants
|
|
Number of Participants With TLF and Individual TLF Components
6-24 hours post-index TLF Component: Clinically-driven TLR
|
2 Participants
|
2 Participants
|
|
Number of Participants With TLF and Individual TLF Components
1-month TLF Total
|
37 Participants
|
32 Participants
|
|
Number of Participants With TLF and Individual TLF Components
1-month TLF Component: Cardiac Death
|
1 Participants
|
1 Participants
|
|
Number of Participants With TLF and Individual TLF Components
1-month TLF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI
|
36 Participants
|
30 Participants
|
|
Number of Participants With TLF and Individual TLF Components
1-month TLF Component: Clinically-driven TLR
|
4 Participants
|
3 Participants
|
|
Number of Participants With TLF and Individual TLF Components
6-month TLF Total
|
47 Participants
|
39 Participants
|
|
Number of Participants With TLF and Individual TLF Components
6-month TLF Component: Cardiac Death
|
1 Participants
|
2 Participants
|
|
Number of Participants With TLF and Individual TLF Components
6-month TLF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI
|
38 Participants
|
34 Participants
|
|
Number of Participants With TLF and Individual TLF Components
6-month TLF Component: Clinically-driven TLR
|
13 Participants
|
8 Participants
|
|
Number of Participants With TLF and Individual TLF Components
12-month TLF Total
|
52 Participants
|
41 Participants
|
|
Number of Participants With TLF and Individual TLF Components
12-month TLF Component: Cardiac Death
|
1 Participants
|
3 Participants
|
|
Number of Participants With TLF and Individual TLF Components
12-month TLF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI
|
39 Participants
|
35 Participants
|
|
Number of Participants With TLF and Individual TLF Components
12-month TLF Component: Clinically-driven TLR
|
17 Participants
|
10 Participants
|
|
Number of Participants With TLF and Individual TLF Components
2-year TLF Component: Cardiac Death
|
5 Participants
|
2 Participants
|
|
Number of Participants With TLF and Individual TLF Components
2-year TLF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI
|
45 Participants
|
39 Participants
|
|
Number of Participants With TLF and Individual TLF Components
2-year TLF Component: Clinically-driven TLR
|
21 Participants
|
19 Participants
|
|
Number of Participants With TLF and Individual TLF Components
3-year TLF Total
|
72 Participants
|
56 Participants
|
|
Number of Participants With TLF and Individual TLF Components
3-year TLF Component: Cardiac Death
|
9 Participants
|
5 Participants
|
|
Number of Participants With TLF and Individual TLF Components
3-year TLF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI
|
46 Participants
|
41 Participants
|
|
Number of Participants With TLF and Individual TLF Components
3-year TLF Component: Clinically-driven TLR
|
27 Participants
|
25 Participants
|
|
Number of Participants With TLF and Individual TLF Components
4-year TLF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI
|
49 Participants
|
44 Participants
|
|
Number of Participants With TLF and Individual TLF Components
4-year TLF Component: Clinically-driven TLR
|
38 Participants
|
28 Participants
|
|
Number of Participants With TLF and Individual TLF Components
5-year TLF Total
|
104 Participants
|
66 Participants
|
|
Number of Participants With TLF and Individual TLF Components
5-year TLF Component: Cardiac Death
|
21 Participants
|
8 Participants
|
|
Number of Participants With TLF and Individual TLF Components
5-year TLF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI
|
56 Participants
|
45 Participants
|
|
Number of Participants With TLF and Individual TLF Components
5-year TLF Component: Clinically-driven TLR
|
48 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Hospital Discharge (6-24 hours post-index procedure), 1, 6, 12 months, 2, 3, 4 and 5 yearsPopulation: Analysis population for each outcome measure time frame is based on participants completing or experiencing an event at that time frame.
TVF events are defined as cardiac death, target vessel Q-wave or non-Q-wave MI, or any clinically-driven TVR. The number of participants with any TVF event is provided, as well as number of participants with each of the individual components.
Outcome measures
| Measure |
Orsiro Sirolimus Coronary Stent System
n=883 Participants
Intervention with a Orsiro DES.
Orsiro DES: Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.
|
Xience Everolimus Coronary Stent System
n=449 Participants
Intervention with a Xience DES.
Xience DES
|
|---|---|---|
|
Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components
6-24 hours post-index TVF Total
|
35 Participants
|
31 Participants
|
|
Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components
6-24 hours post-index TVF Component: Cardiac Death
|
1 Participants
|
1 Participants
|
|
Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components
6-24 hours post-index TVF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI
|
34 Participants
|
29 Participants
|
|
Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components
6-24 hours post-index TVF Component: Clinically-driven TVR
|
2 Participants
|
2 Participants
|
|
Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components
1-month TVF Total
|
38 Participants
|
32 Participants
|
|
Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components
1-month TVF Component: Cardiac Death
|
1 Participants
|
1 Participants
|
|
Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components
1-month TVF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI
|
36 Participants
|
30 Participants
|
|
Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components
1-month TVF Component: Clinically-driven TVR
|
5 Participants
|
4 Participants
|
|
Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components
6-month TVF Total
|
51 Participants
|
40 Participants
|
|
Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components
6-month TVF Component: Cardiac Death
|
1 Participants
|
2 Participants
|
|
Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components
6-month TVF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI
|
38 Participants
|
34 Participants
|
|
Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components
6-month TVF Component: Clinically-driven TVR
|
18 Participants
|
10 Participants
|
|
Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components
12-month TVF Total
|
60 Participants
|
45 Participants
|
|
Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components
12-month TVF Component: Cardiac Death
|
1 Participants
|
3 Participants
|
|
Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components
12-month TVF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI
|
39 Participants
|
35 Participants
|
|
Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components
12-month TVF Component: Clinically-driven TVR
|
27 Participants
|
15 Participants
|
|
Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components
2-year TVF Total
|
74 Participants
|
56 Participants
|
|
Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components
2-year TVF Component: Cardiac Death
|
5 Participants
|
2 Participants
|
|
Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components
2-year TVF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI
|
45 Participants
|
39 Participants
|
|
Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components
2-year TVF Component: Clinically-driven TVR
|
37 Participants
|
30 Participants
|
|
Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components
3-year TVF Total
|
84 Participants
|
68 Participants
|
|
Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components
3-year TVF Component: Cardiac Death
|
9 Participants
|
5 Participants
|
|
Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components
3-year TVF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI
|
46 Participants
|
41 Participants
|
|
Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components
3-year TVF Component: Clinically-driven TVR
|
45 Participants
|
40 Participants
|
|
Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components
4-year TVF Total
|
110 Participants
|
74 Participants
|
|
Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components
4-year TVF Component: Cardiac Death
|
17 Participants
|
5 Participants
|
|
Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components
4-year TVF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI
|
49 Participants
|
44 Participants
|
|
Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components
4-year TVF Component: Clinically-driven TVR
|
63 Participants
|
46 Participants
|
|
Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components
5-year TVF Total
|
127 Participants
|
81 Participants
|
|
Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components
5-year TVF Component: Cardiac Death
|
21 Participants
|
8 Participants
|
|
Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components
5-year TVF Component: Protocol-defined Target Vessel Q-wave or non-Q-Wave MI
|
56 Participants
|
45 Participants
|
|
Number of Participants With Target Vessel Failure (TVF) and Individual TVF Components
5-year TVF Component: Clinically-driven TVR
|
78 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: 24 hours, 30 days, 1 year, and 5 years post-index procedurePopulation: Analysis population for each outcome measure time frame is based on participants completing or experiencing an event at that time frame.
Stent thrombosis according to the Academic Research Consortium criteria.
Outcome measures
| Measure |
Orsiro Sirolimus Coronary Stent System
n=884 Participants
Intervention with a Orsiro DES.
Orsiro DES: Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.
|
Xience Everolimus Coronary Stent System
n=450 Participants
Intervention with a Xience DES.
Xience DES
|
|---|---|---|
|
Number of Participants With Stent Thrombosis
Possible ARC Stent Thrombosis Sub-acute (>24 hours and <=30 days)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Stent Thrombosis
Possible ARC Stent Thrombosis Late (>30 days and <=1 year)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Stent Thrombosis
Possible ARC Stent Thrombosis Total
|
11 Participants
|
6 Participants
|
|
Number of Participants With Stent Thrombosis
Possible ARC Stent Thrombosis Acute (<=24 hours)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Stent Thrombosis
Possible ARC Stent Thrombosis Very Late (>1 year)
|
11 Participants
|
5 Participants
|
|
Number of Participants With Stent Thrombosis
Definite/Probable ARC Stent Thrombosis Total
|
5 Participants
|
7 Participants
|
|
Number of Participants With Stent Thrombosis
Definite/Probable ARC Stent Thrombosis Acute (<=24 hours)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Stent Thrombosis
Definite/Probable ARC Stent Thrombosis Sub-acute (>24 hours and <=30 days)
|
2 Participants
|
1 Participants
|
|
Number of Participants With Stent Thrombosis
Definite/Probable ARC Stent Thrombosis Late (>30 days and <=1 year)
|
1 Participants
|
2 Participants
|
|
Number of Participants With Stent Thrombosis
Definite/Probable ARC Stent Thrombosis Very Late (>1 year)
|
1 Participants
|
4 Participants
|
Adverse Events
Orsiro Sirolimus Coronary Stent System
Serious events: 548 serious events
Other events: 291 other events
Deaths: 56 deaths
Xience Everolimus Coronary Stent System
Serious events: 293 serious events
Other events: 165 other events
Deaths: 27 deaths
Serious adverse events
| Measure |
Orsiro Sirolimus Coronary Stent System
n=884 participants at risk
Intervention with a Orsiro DES.
Orsiro DES: Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.
|
Xience Everolimus Coronary Stent System
n=450 participants at risk
Intervention with a Xience DES.
Xience DES
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
11/884 • Number of events 12 • 5 year
|
1.1%
5/450 • Number of events 5 • 5 year
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.57%
5/884 • Number of events 5 • 5 year
|
0.67%
3/450 • Number of events 3 • 5 year
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.11%
1/884 • Number of events 2 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Cardiac disorders
Acute coronary syndrome
|
0.68%
6/884 • Number of events 7 • 5 year
|
1.1%
5/450 • Number of events 5 • 5 year
|
|
Cardiac disorders
Acute myocardial infarction
|
5.2%
46/884 • Number of events 58 • 5 year
|
5.3%
24/450 • Number of events 33 • 5 year
|
|
Cardiac disorders
Angina pectoris
|
9.6%
85/884 • Number of events 105 • 5 year
|
10.9%
49/450 • Number of events 61 • 5 year
|
|
Cardiac disorders
Angina unstable
|
6.0%
53/884 • Number of events 64 • 5 year
|
7.1%
32/450 • Number of events 43 • 5 year
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.44%
2/450 • Number of events 6 • 5 year
|
|
Cardiac disorders
Atrial fibrillation
|
4.1%
36/884 • Number of events 48 • 5 year
|
4.0%
18/450 • Number of events 26 • 5 year
|
|
Cardiac disorders
Atrial flutter
|
0.79%
7/884 • Number of events 8 • 5 year
|
0.89%
4/450 • Number of events 4 • 5 year
|
|
Cardiac disorders
Atrial tachycardia
|
0.23%
2/884 • Number of events 5 • 5 year
|
0.00%
0/450 • 5 year
|
|
Cardiac disorders
Atrioventricular block complete
|
0.34%
3/884 • Number of events 3 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Cardiac disorders
Bradycardia
|
0.79%
7/884 • Number of events 7 • 5 year
|
0.89%
4/450 • Number of events 5 • 5 year
|
|
Cardiac disorders
Cardiac arrest
|
0.34%
3/884 • Number of events 3 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Cardiac disorders
Cardiac failure acute
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Cardiac disorders
Cardiac failure congestive
|
2.3%
20/884 • Number of events 36 • 5 year
|
2.2%
10/450 • Number of events 14 • 5 year
|
|
Cardiac disorders
Cardiac failure
|
1.7%
15/884 • Number of events 17 • 5 year
|
1.1%
5/450 • Number of events 5 • 5 year
|
|
Cardiac disorders
Cardiac pseudoaneurysm
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Cardiac disorders
Cardiac tamponade
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Cardiac disorders
Cardiomyopathy
|
0.34%
3/884 • Number of events 3 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Cardiac disorders
Coronary artery disease
|
1.8%
16/884 • Number of events 23 • 5 year
|
2.9%
13/450 • Number of events 16 • 5 year
|
|
Cardiac disorders
Coronary artery dissection
|
2.6%
23/884 • Number of events 24 • 5 year
|
4.4%
20/450 • Number of events 22 • 5 year
|
|
Cardiac disorders
Coronary artery embolism
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Cardiac disorders
Coronary artery occlusion
|
1.2%
11/884 • Number of events 13 • 5 year
|
2.2%
10/450 • Number of events 10 • 5 year
|
|
Cardiac disorders
Coronary artery stenosis
|
13.0%
115/884 • Number of events 205 • 5 year
|
12.9%
58/450 • Number of events 121 • 5 year
|
|
Cardiac disorders
Diastolic dysfunction
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Cardiac disorders
Microvascular coronary artery disease
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Cardiac disorders
Mitral valve prolapse
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Cardiac disorders
Myocardial infarction
|
0.68%
6/884 • Number of events 6 • 5 year
|
1.6%
7/450 • Number of events 7 • 5 year
|
|
Cardiac disorders
Myocardial rupture
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Cardiac disorders
Pericarditis
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Cardiac disorders
Prinzmetal angina
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 2 • 5 year
|
|
Cardiac disorders
Sinus arrest
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/884 • 5 year
|
0.67%
3/450 • Number of events 4 • 5 year
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.67%
3/450 • Number of events 3 • 5 year
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Cardiac disorders
Ventricular fibrillation
|
0.23%
2/884 • Number of events 3 • 5 year
|
0.67%
3/450 • Number of events 3 • 5 year
|
|
Cardiac disorders
Ventricular tachycardia
|
0.68%
6/884 • Number of events 8 • 5 year
|
0.67%
3/450 • Number of events 4 • 5 year
|
|
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Eye disorders
Cataract
|
1.2%
11/884 • Number of events 17 • 5 year
|
0.89%
4/450 • Number of events 4 • 5 year
|
|
Eye disorders
Retinal detachment
|
0.34%
3/884 • Number of events 3 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Eye disorders
Visual acuity reduced
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Eye disorders
Visual impairment
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.67%
3/450 • Number of events 3 • 5 year
|
|
Gastrointestinal disorders
Abdominal pain
|
0.45%
4/884 • Number of events 5 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Gastrointestinal disorders
Alcoholic pancreatitis
|
0.11%
1/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Colitis
|
0.34%
3/884 • Number of events 3 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Gastrointestinal disorders
Diarrhoea
|
0.34%
3/884 • Number of events 4 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Gastrointestinal disorders
Diverticulum
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Dysphagia
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.89%
4/450 • Number of events 4 • 5 year
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Gastritis
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.5%
13/884 • Number of events 15 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Gastrointestinal disorders
Haematochezia
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Intestinal angina
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Melaena
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Gastrointestinal disorders
Nausea
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Gastrointestinal disorders
Oesophageal rupture
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.45%
4/884 • Number of events 6 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Gastrointestinal disorders
Pancreatitis
|
0.45%
4/884 • Number of events 9 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.45%
4/884 • Number of events 5 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Gastrointestinal disorders
Rectal polyp
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Gastrointestinal disorders
Retroperitoneal mass
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.68%
6/884 • Number of events 8 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Stomach granuloma
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Tongue haemorrhage
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Vomiting
|
0.34%
3/884 • Number of events 3 • 5 year
|
0.00%
0/450 • 5 year
|
|
General disorders
Accidental death
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
General disorders
Asthenia
|
0.45%
4/884 • Number of events 6 • 5 year
|
0.67%
3/450 • Number of events 3 • 5 year
|
|
General disorders
Catheter site haematoma
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
General disorders
Chest pain
|
2.5%
22/884 • Number of events 25 • 5 year
|
1.3%
6/450 • Number of events 6 • 5 year
|
|
General disorders
Death
|
0.90%
8/884 • Number of events 8 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
General disorders
Incarcerated hernia
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
General disorders
Multi-organ failure
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
General disorders
Non-cardiac chest pain
|
10.4%
92/884 • Number of events 121 • 5 year
|
9.1%
41/450 • Number of events 61 • 5 year
|
|
General disorders
Pyrexia
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
General disorders
Vascular stent restenosis
|
2.7%
24/884 • Number of events 27 • 5 year
|
3.1%
14/450 • Number of events 15 • 5 year
|
|
General disorders
Vascular stent stenosis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
General disorders
Vascular stent thrombosis
|
0.11%
1/884 • Number of events 2 • 5 year
|
0.89%
4/450 • Number of events 4 • 5 year
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.45%
4/884 • Number of events 4 • 5 year
|
0.00%
0/450 • 5 year
|
|
Hepatobiliary disorders
Cholecystitis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.34%
3/884 • Number of events 3 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Hepatobiliary disorders
Hepatitis alcoholic
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Immune system disorders
Serum sickness
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Infections and infestations
Abdominal wall abscess
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Infections and infestations
Abscess limb
|
0.23%
2/884 • Number of events 3 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Infections and infestations
Anal abscess
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Infections and infestations
Beta haemolytic streptococcal infection
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Infections and infestations
Bronchitis
|
0.34%
3/884 • Number of events 4 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Infections and infestations
Catheter site abscess
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Infections and infestations
Cellulitis streptococcal
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Infections and infestations
Cellulitis
|
0.90%
8/884 • Number of events 13 • 5 year
|
0.89%
4/450 • Number of events 4 • 5 year
|
|
Infections and infestations
Cholecystitis infective
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Infections and infestations
Clostridium difficile colitis
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Infections and infestations
Emphysematous cholecystitis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Infections and infestations
Enteritis infectious
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Infections and infestations
Gastroenteritis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Infections and infestations
Herpes zoster
|
0.11%
1/884 • Number of events 3 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Infections and infestations
Peritonitis
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Infections and infestations
Pneumonia
|
3.3%
29/884 • Number of events 31 • 5 year
|
2.2%
10/450 • Number of events 15 • 5 year
|
|
Infections and infestations
Pulmonary sepsis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Infections and infestations
Scrotal abscess
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Infections and infestations
Sepsis
|
1.5%
13/884 • Number of events 14 • 5 year
|
2.0%
9/450 • Number of events 10 • 5 year
|
|
Infections and infestations
Septic shock
|
0.45%
4/884 • Number of events 4 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Infections and infestations
Sinusitis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Infections and infestations
Staphylococcal infection
|
0.23%
2/884 • Number of events 3 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/884 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Infections and infestations
Urinary tract infection
|
1.7%
15/884 • Number of events 18 • 5 year
|
1.3%
6/450 • Number of events 6 • 5 year
|
|
Infections and infestations
Vestibular neuronitis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Infections and infestations
Viral infection
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Infections and infestations
Wound infection
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Injury, poisoning and procedural complications
Asbestosis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Injury, poisoning and procedural complications
Cardiac procedure complication
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Injury, poisoning and procedural complications
Contusion
|
0.23%
2/884 • Number of events 3 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.23%
2/884 • Number of events 2 • 5 year
|
1.1%
5/450 • Number of events 5 • 5 year
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.45%
4/884 • Number of events 5 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Injury, poisoning and procedural complications
Laceration
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.44%
2/450 • Number of events 3 • 5 year
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.34%
3/884 • Number of events 3 • 5 year
|
0.00%
0/450 • 5 year
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.67%
3/450 • Number of events 3 • 5 year
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/884 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.23%
2/884 • Number of events 3 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Investigations
Blood creatinine increased
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Investigations
Cardiac stress test abnormal
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Investigations
Haemoglobin decreased
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Investigations
Myocardial necrosis marker increased
|
0.34%
3/884 • Number of events 3 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Investigations
Prostatic specific antigen increased
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Investigations
Troponin increased
|
0.34%
3/884 • Number of events 3 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.45%
4/884 • Number of events 4 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/884 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.34%
3/884 • Number of events 5 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.68%
6/884 • Number of events 7 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.57%
5/884 • Number of events 5 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.11%
1/884 • Number of events 1 • 5 year
|
1.1%
5/450 • Number of events 5 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.23%
2/884 • Number of events 3 • 5 year
|
0.89%
4/450 • Number of events 4 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.57%
5/884 • Number of events 5 • 5 year
|
0.00%
0/450 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.8%
16/884 • Number of events 20 • 5 year
|
2.4%
11/450 • Number of events 12 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.45%
4/884 • Number of events 4 • 5 year
|
0.67%
3/450 • Number of events 3 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.68%
6/884 • Number of events 6 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.90%
8/884 • Number of events 8 • 5 year
|
0.67%
3/450 • Number of events 3 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyoma
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.57%
5/884 • Number of events 5 • 5 year
|
1.1%
5/450 • Number of events 5 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.68%
6/884 • Number of events 7 • 5 year
|
0.67%
3/450 • Number of events 4 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Nervous system disorders
Carotid artery disease
|
0.23%
2/884 • Number of events 3 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Nervous system disorders
Carotid artery stenosis
|
0.90%
8/884 • Number of events 8 • 5 year
|
0.89%
4/450 • Number of events 5 • 5 year
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Nervous system disorders
Cerebral infarction
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Nervous system disorders
Cerebrovascular accident
|
0.23%
2/884 • Number of events 3 • 5 year
|
1.1%
5/450 • Number of events 7 • 5 year
|
|
Nervous system disorders
Diabetic neuropathy
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Nervous system disorders
Dizziness
|
1.0%
9/884 • Number of events 9 • 5 year
|
0.89%
4/450 • Number of events 4 • 5 year
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/884 • 5 year
|
0.67%
3/450 • Number of events 3 • 5 year
|
|
Nervous system disorders
Headache
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.67%
3/450 • Number of events 3 • 5 year
|
|
Nervous system disorders
Ischaemic stroke
|
0.45%
4/884 • Number of events 5 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Nervous system disorders
Migraine
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Nervous system disorders
Myoclonus
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Nervous system disorders
Neuropathy peripheral
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Nervous system disorders
Paraesthesia
|
0.34%
3/884 • Number of events 3 • 5 year
|
0.00%
0/450 • 5 year
|
|
Nervous system disorders
Presyncope
|
0.68%
6/884 • Number of events 6 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Nervous system disorders
Syncope
|
2.3%
20/884 • Number of events 21 • 5 year
|
1.6%
7/450 • Number of events 7 • 5 year
|
|
Nervous system disorders
Thalamic infarction
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Nervous system disorders
Transient ischaemic attack
|
0.45%
4/884 • Number of events 5 • 5 year
|
0.89%
4/450 • Number of events 4 • 5 year
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.67%
3/450 • Number of events 3 • 5 year
|
|
Psychiatric disorders
Confusional state
|
0.34%
3/884 • Number of events 3 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Psychiatric disorders
Delirium
|
0.00%
0/884 • 5 year
|
0.89%
4/450 • Number of events 4 • 5 year
|
|
Psychiatric disorders
Major depression
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Psychiatric disorders
Mental status changes
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Psychiatric disorders
Suicidal ideation
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Renal and urinary disorders
Acute kidney injury
|
2.4%
21/884 • Number of events 30 • 5 year
|
2.4%
11/450 • Number of events 17 • 5 year
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Renal and urinary disorders
Calculus ureteric
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.44%
2/450 • Number of events 3 • 5 year
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.4%
12/884 • Number of events 12 • 5 year
|
0.67%
3/450 • Number of events 3 • 5 year
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Renal and urinary disorders
Haematuria
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Renal and urinary disorders
Hydronephrosis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.68%
6/884 • Number of events 10 • 5 year
|
0.67%
3/450 • Number of events 3 • 5 year
|
|
Renal and urinary disorders
Renal cyst
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Renal and urinary disorders
Renal failure
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Renal and urinary disorders
Renal mass
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Renal and urinary disorders
Urinary retention
|
0.68%
6/884 • Number of events 6 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.0%
9/884 • Number of events 13 • 5 year
|
0.67%
3/450 • Number of events 3 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.5%
13/884 • Number of events 26 • 5 year
|
2.0%
9/450 • Number of events 12 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
1.0%
9/884 • Number of events 9 • 5 year
|
0.67%
3/450 • Number of events 4 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.3%
29/884 • Number of events 33 • 5 year
|
2.4%
11/450 • Number of events 11 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.45%
4/884 • Number of events 7 • 5 year
|
1.3%
6/450 • Number of events 7 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.45%
4/884 • Number of events 5 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.11%
1/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.45%
4/884 • Number of events 4 • 5 year
|
0.67%
3/450 • Number of events 3 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.0%
9/884 • Number of events 9 • 5 year
|
0.67%
3/450 • Number of events 3 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Skin and subcutaneous tissue disorders
Diffuse cutaneous mastocytosis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Skin and subcutaneous tissue disorders
Pruritus allergic
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Skin and subcutaneous tissue disorders
Red man syndrome
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Vascular disorders
Aortic aneurysm
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Vascular disorders
Aortic stenosis
|
0.79%
7/884 • Number of events 7 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Vascular disorders
Femoral artery dissection
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Vascular disorders
Haemodynamic instability
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Vascular disorders
Haemorrhage
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Vascular disorders
Hypertension
|
0.57%
5/884 • Number of events 5 • 5 year
|
1.3%
6/450 • Number of events 6 • 5 year
|
|
Vascular disorders
Hypertensive crisis
|
0.79%
7/884 • Number of events 8 • 5 year
|
0.22%
1/450 • Number of events 2 • 5 year
|
|
Vascular disorders
Hypotension
|
0.79%
7/884 • Number of events 7 • 5 year
|
1.1%
5/450 • Number of events 5 • 5 year
|
|
Vascular disorders
Iliac artery occlusion
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Vascular disorders
Intermittent claudication
|
0.45%
4/884 • Number of events 6 • 5 year
|
0.89%
4/450 • Number of events 6 • 5 year
|
|
Vascular disorders
Lymphoedema
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.90%
8/884 • Number of events 9 • 5 year
|
0.89%
4/450 • Number of events 5 • 5 year
|
|
Vascular disorders
Peripheral artery stenosis
|
1.1%
10/884 • Number of events 11 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Vascular disorders
Peripheral ischaemia
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Vascular disorders
Peripheral vascular disorder
|
0.57%
5/884 • Number of events 5 • 5 year
|
0.67%
3/450 • Number of events 3 • 5 year
|
|
Vascular disorders
Subclavian artery stenosis
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Vascular disorders
Varicose vein
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Blood and lymphatic system disorders
Histiocytosis haematophagic
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Cardiac disorders
Anginal equivalent
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Cardiac disorders
Aortic valve stenosis
|
0.34%
3/884 • Number of events 3 • 5 year
|
0.00%
0/450 • 5 year
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Cardiac disorders
Atrioventricular block
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Cardiac disorders
Bundle branch block left
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Cardiac disorders
Bundle branch block right
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Cardiac disorders
Cardiac failure chronic
|
0.45%
4/884 • Number of events 4 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Cardiac disorders
Cardiogenic shock
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Cardiac disorders
Coronary artery perforation
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Cardiac disorders
Coronary ostial stenosis
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Cardiac disorders
Low cardiac output syndrome
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Cardiac disorders
Mitral valve incompetence
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Cardiac disorders
Myocardial ischaemia
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Cardiac disorders
Nodal rhythm
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Cardiac disorders
Palpitations
|
0.34%
3/884 • Number of events 3 • 5 year
|
0.67%
3/450 • Number of events 3 • 5 year
|
|
Cardiac disorders
Sinus bradycardia
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.34%
3/884 • Number of events 3 • 5 year
|
0.00%
0/450 • 5 year
|
|
Cardiac disorders
Tachycardia
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Congenital, familial and genetic disorders
Developmental hip dysplasia
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Congenital, familial and genetic disorders
Pyloric stenosis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Ear and labyrinth disorders
Vertigo
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Endocrine disorders
Adrenal mass
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/884 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Endocrine disorders
Toxic nodular goitre
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Eye disorders
Amaurosis fugax
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Eye disorders
Diplopia
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Eye disorders
Glaucoma
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Eye disorders
Macular hole
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Eye disorders
Necrotising retinitis
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Eye disorders
Retinal artery embolism
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Eye disorders
Retinal haemorrhage
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Anal fissure
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Anal fistula
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Anal polyp
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Constipation
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Dyspepsia
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Enteritis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Gastrointestinal polyp haemorrhage
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Gastrointestinal disorders
Gastrointestinal ulcer
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Ileus
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.45%
4/884 • Number of events 4 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Large intestinal polyp
|
0.34%
3/884 • Number of events 3 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Pancreatitis relapsing
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Pharyngo-oesophageal diverticulum
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.34%
3/884 • Number of events 3 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
General disorders
Cyst
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
General disorders
Fatigue
|
0.34%
3/884 • Number of events 3 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
General disorders
Gait disturbance
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
General disorders
General physical health deterioration
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
General disorders
Impaired healing
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
General disorders
Local swelling
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
General disorders
Oedema peripheral
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
General disorders
Pain
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
General disorders
Peripheral swelling
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Hepatobiliary disorders
Cholangitis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Hepatobiliary disorders
Hepatic failure
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Hepatobiliary disorders
Hepatitis cholestatic
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Infections and infestations
Abscess neck
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Infections and infestations
Appendicitis
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Infections and infestations
Arteriovenous fistula site infection
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Infections and infestations
Arthritis bacterial
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Infections and infestations
Atypical pneumonia
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Infections and infestations
Bacteraemia
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Infections and infestations
Bacterial pyelonephritis
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Infections and infestations
Corona virus infection
|
0.68%
6/884 • Number of events 6 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Infections and infestations
Cystitis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Infections and infestations
Device related infection
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Infections and infestations
Diverticulitis
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Infections and infestations
Erysipelas
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Infections and infestations
Febrile infection
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Infections and infestations
Gangrene
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Infections and infestations
Hepatitis A
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Infections and infestations
Herpes zoster oticus
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Infections and infestations
Implant site infection
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Infections and infestations
Incision site cellulitis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Infections and infestations
Infected skin ulcer
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Infections and infestations
Infection
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Infections and infestations
Infectious colitis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Infections and infestations
Influenza
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Infections and infestations
Klebsiella infection
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Infections and infestations
Lower respiratory tract infection
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Infections and infestations
Lung abscess
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Infections and infestations
Lung infection
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Infections and infestations
Medical device site infection
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Infections and infestations
Osteomyelitis
|
0.34%
3/884 • Number of events 3 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Infections and infestations
Otitis externa
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Infections and infestations
Paronychia
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Infections and infestations
Picornavirus infection
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Infections and infestations
Pneumococcal sepsis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/884 • 5 year
|
0.67%
3/450 • Number of events 3 • 5 year
|
|
Infections and infestations
Post procedural infection
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Infections and infestations
Pyelonephritis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Infections and infestations
Skin infection
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Infections and infestations
Staphylococcal sepsis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/884 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Infections and infestations
Urinary tract infection staphylococcal
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Infections and infestations
Urosepsis
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Infections and infestations
Viral pericarditis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Injury, poisoning and procedural complications
Concussion
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Injury, poisoning and procedural complications
Fall
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.34%
3/884 • Number of events 3 • 5 year
|
0.00%
0/450 • 5 year
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.34%
3/884 • Number of events 3 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Injury, poisoning and procedural complications
Incomplete spinal fusion
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Injury, poisoning and procedural complications
Overdose
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Injury, poisoning and procedural complications
Wound
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Investigations
Blood pressure increased
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Investigations
Brain natriuretic peptide increased
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Investigations
Carotid bruit
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Investigations
Electrocardiogram ST segment elevaction
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Investigations
Scan myocardial perfusion abnormal
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Metabolism and nutrition disorders
Gout
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Metabolism and nutrition disorders
Obesity
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Back disorder
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.34%
3/884 • Number of events 3 • 5 year
|
0.67%
3/450 • Number of events 3 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Deformity thorax
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Joint hyperextension
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Monarthritis
|
0.00%
0/884 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Polymyositis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.11%
1/884 • 5 year
|
0.00%
0/450 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/884 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypergammaglobulinaemia benign monoclonal
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.67%
3/450 • Number of events 3 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage III
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma benign
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic bronchial carcinoma
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nodular melanoma
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage I
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neuroendocrine tumor
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumor benign
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 11 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland cancer
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer metastatic
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma urethra
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.45%
4/884 • Number of events 5 • 5 year
|
0.00%
0/450 • 5 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urethral cancer metastatic
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Nervous system disorders
Amyotropic lateral sclerosis
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Nervous system disorders
Brain stem haemorrhage
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Nervous system disorders
Brain stem infarction
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Nervous system disorders
Central nervous system lesion
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Nervous system disorders
Cerebral ischaemia
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Nervous system disorders
Complex regional pain syndrome
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Nervous system disorders
Dementia
|
0.00%
0/884 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Nervous system disorders
Encephalopathy
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Nervous system disorders
Hemiparesis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.89%
4/450 • Number of events 4 • 5 year
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Nervous system disorders
Hypokinesia
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Nervous system disorders
Intracranial aneurysm
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Nervous system disorders
Lacunar stroke
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.34%
3/884 • Number of events 3 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Nervous system disorders
Myelopathy
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Nervous system disorders
Partial seizures
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Nervous system disorders
Polyneuropathy idiopathic progressive
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Nervous system disorders
Radicular pain
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Nervous system disorders
Ruptured cerebral aneurysm
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Nervous system disorders
Sciatica
|
0.34%
3/884 • Number of events 3 • 5 year
|
0.00%
0/450 • 5 year
|
|
Nervous system disorders
Seizure
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Nervous system disorders
Somnolence
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Nervous system disorders
Toxic encephalopathy
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Nervous system disorders
Transient global amnesia
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Psychiatric disorders
Alcohol abuse
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Psychiatric disorders
Depression
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Psychiatric disorders
Drug dependence
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Psychiatric disorders
Mood altered
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Psychiatric disorders
Psychotic disorder
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Psychiatric disorders
Psychosomatic disease
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Psychiatric disorders
Suicide attempt
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Renal and urinary disorders
Dysuria
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Renal and urinary disorders
Lower urinary tract symptoms
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Renal and urinary disorders
Nephrosclerosis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Renal and urinary disorders
Nocturia
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.34%
3/884 • Number of events 3 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Reproductive system and breast disorders
Pelvic prolapse
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Reproductive system and breast disorders
Vaginal dysplasia
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Eosinophilic pneumonia
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate hypertrophy
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Pickwickian syndrome
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.34%
3/884 • Number of events 3 • 5 year
|
0.00%
0/450 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Surgical and medical procedures
Cardiac ablation
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Surgical and medical procedures
Cardiac pacemaker replacement
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Surgical and medical procedures
Medical device removal
|
0.00%
0/884 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Vascular disorders
Arteriosclerosis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Vascular disorders
Arteriovenous fistula
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Vascular disorders
Blood pressure inadequately controlled
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Vascular disorders
Brachiocephalic artery stenosis
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Vascular disorders
Deep vein thrombosis
|
0.57%
5/884 • Number of events 6 • 5 year
|
0.44%
2/450 • Number of events 2 • 5 year
|
|
Vascular disorders
Femoral artery occlusion
|
0.23%
2/884 • Number of events 2 • 5 year
|
0.00%
0/450 • 5 year
|
|
Vascular disorders
Haematoma
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Vascular disorders
Hypovolaemic shock
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Vascular disorders
Labile hypertension
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Vascular disorders
Malignant hypertension
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Vascular disorders
May-Thurner syndrome
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Vascular disorders
Orthostatic hypotension
|
0.68%
6/884 • Number of events 6 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Vascular disorders
Penetrating aortic ulcer
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/884 • 5 year
|
0.22%
1/450 • Number of events 1 • 5 year
|
|
Vascular disorders
Steal syndrome
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Vascular disorders
Subgaleal haematoma
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
|
Vascular disorders
Temporal arteritis
|
0.11%
1/884 • Number of events 1 • 5 year
|
0.00%
0/450 • 5 year
|
Other adverse events
| Measure |
Orsiro Sirolimus Coronary Stent System
n=884 participants at risk
Intervention with a Orsiro DES.
Orsiro DES: Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.
|
Xience Everolimus Coronary Stent System
n=450 participants at risk
Intervention with a Xience DES.
Xience DES
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
18.0%
159/884 • Number of events 215 • 5 year
|
20.9%
94/450 • Number of events 125 • 5 year
|
|
General disorders
Non-cardiac chest pain
|
18.4%
163/884 • Number of events 240 • 5 year
|
19.8%
89/450 • Number of events 128 • 5 year
|
|
Investigations
Myocardial necrosis marker increased
|
19.7%
174/884 • Number of events 176 • 5 year
|
20.0%
90/450 • Number of events 91 • 5 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.3%
100/884 • Number of events 112 • 5 year
|
10.0%
45/450 • Number of events 52 • 5 year
|
|
Cardiac disorders
Acute Myocardial Infarction
|
5.5%
49/884 • Number of events 61 • 5 year
|
5.8%
26/450 • Number of events 35 • 5 year
|
|
Cardiac disorders
Angina Unstable
|
7.6%
67/884 • Number of events 89 • 5 year
|
8.9%
40/450 • Number of events 54 • 5 year
|
|
Cardiac disorders
Atrial Fibrillation
|
6.8%
60/884 • Number of events 75 • 5 year
|
6.0%
27/450 • Number of events 38 • 5 year
|
|
Cardiac disorders
Coronary Artery Dissection
|
3.6%
32/884 • Number of events 33 • 5 year
|
5.3%
24/450 • Number of events 26 • 5 year
|
|
Cardiac disorders
Coronary Artery Stenosis
|
13.6%
120/884 • Number of events 215 • 5 year
|
13.6%
61/450 • Number of events 126 • 5 year
|
|
General disorders
Fatigue
|
4.1%
36/884 • Number of events 36 • 5 year
|
5.6%
25/450 • Number of events 25 • 5 year
|
|
Nervous system disorders
Dizziness
|
5.8%
51/884 • Number of events 51 • 5 year
|
4.7%
21/450 • Number of events 22 • 5 year
|
Additional Information
Amy Culley, Director of Vascular Intervention Clinical Studies
BIOTRONIK, Inc
Phone: 503-451-8034
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place