Trial Outcomes & Findings for A Study to Assess the Efficacy and Safety of Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease (NCT NCT00501059)
NCT ID: NCT00501059
Last Updated: 2018-10-26
Results Overview
The primary efficacy endpoint was a composite outcome consisting of the first occurrence of confirmed MI, stroke, cardiovascular death, UA, TIA. The time to event was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
12546 participants
Primary outcome timeframe
Until follow-up (approximate 6 years)
Results posted on
2018-10-26
Participant Flow
Overall, 15823 subjects were screened. Of these, 3277 subjects were screening failures. The remaining 12546 subjects were randomized to treatment.
Participant milestones
| Measure |
Acetylsalicylic Acid (Aspirin, BAYE4465)
Subjects received 1 tablet of enteric-coated acetylsalicylic acid \[100 milligram (mg)\] orally once daily.
|
Placebo
Subjects received 1 tablets of matching placebo orally once daily.
|
|---|---|---|
|
Overall Study
STARTED
|
6270
|
6276
|
|
Overall Study
COMPLETED
|
4402
|
4384
|
|
Overall Study
NOT COMPLETED
|
1868
|
1892
|
Reasons for withdrawal
| Measure |
Acetylsalicylic Acid (Aspirin, BAYE4465)
Subjects received 1 tablet of enteric-coated acetylsalicylic acid \[100 milligram (mg)\] orally once daily.
|
Placebo
Subjects received 1 tablets of matching placebo orally once daily.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
80
|
69
|
|
Overall Study
Death
|
140
|
137
|
|
Overall Study
Other
|
236
|
239
|
|
Overall Study
Missing end-of-study page
|
91
|
92
|
|
Overall Study
Clinical endpoint reached
|
110
|
123
|
|
Overall Study
Insufficient therapeutic effect
|
4
|
5
|
|
Overall Study
Consent withdrawn by subject
|
817
|
873
|
|
Overall Study
Non-compliant with study treatment
|
23
|
16
|
|
Overall Study
Reason not given
|
3
|
1
|
|
Overall Study
Adverse Event
|
129
|
122
|
|
Overall Study
Lost to Follow-up
|
210
|
198
|
|
Overall Study
Not treated
|
25
|
17
|
Baseline Characteristics
A Study to Assess the Efficacy and Safety of Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease
Baseline characteristics by cohort
| Measure |
Acetylsalicylic Acid (Aspirin, BAYE4465)
n=6270 Participants
Subjects received 1 tablet of enteric-coated acetylsalicylic acid \[100 milligram (mg)\] orally once daily.
|
Placebo
n=6276 Participants
Subjects received 1 tablets of matching placebo orally once daily.
|
Total
n=12546 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.9 Years
STANDARD_DEVIATION 7.10 • n=5 Participants
|
63.9 Years
STANDARD_DEVIATION 7.05 • n=7 Participants
|
63.9 Years
STANDARD_DEVIATION 7.08 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1851 Participants
n=5 Participants
|
1857 Participants
n=7 Participants
|
3708 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4419 Participants
n=5 Participants
|
4419 Participants
n=7 Participants
|
8838 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Until follow-up (approximate 6 years)Population: Intention-to-treat. The intent-to-treat (ITT) group (N=12546) consists of all patients who were randomized to the assigned study drug.
The primary efficacy endpoint was a composite outcome consisting of the first occurrence of confirmed MI, stroke, cardiovascular death, UA, TIA. The time to event was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.
Outcome measures
| Measure |
Acetylsalicylic Acid (Aspirin, BAYE4465)
n=1630 Days
Subjects received 1 tablet of enteric-coated acetylsalicylic acid \[100 milligram (mg)\] orally once daily.
|
Placebo
n=1630 Days
Subjects received 1 tablets of matching placebo orally once daily.
|
|---|---|---|
|
Time to the First Occurrence of the Composite Outcome of MI (Myocardial Infarction), Stroke, Cardiovascular Death, UA (Unstable Angina) or TIA (Transient Ischemic Attack)
Days until 1% subjects had an efficacy event
|
528 Days
|
381 Days
|
|
Time to the First Occurrence of the Composite Outcome of MI (Myocardial Infarction), Stroke, Cardiovascular Death, UA (Unstable Angina) or TIA (Transient Ischemic Attack)
Days until 2% subjects had an efficacy event
|
889 Days
|
796 Days
|
|
Time to the First Occurrence of the Composite Outcome of MI (Myocardial Infarction), Stroke, Cardiovascular Death, UA (Unstable Angina) or TIA (Transient Ischemic Attack)
Days until 3% subjects had an efficacy event
|
1225 Days
|
1134 Days
|
|
Time to the First Occurrence of the Composite Outcome of MI (Myocardial Infarction), Stroke, Cardiovascular Death, UA (Unstable Angina) or TIA (Transient Ischemic Attack)
Days until 4% subjects had an efficacy event
|
1630 Days
|
1582 Days
|
SECONDARY outcome
Timeframe: Until follow-up (approximate 6 years)Population: ITT
The time to Composite outcome consisting of the first occurrence of cardiovascular death, MI, or stroke (ischemic, hemorrhagic, or unknown) was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.
Outcome measures
| Measure |
Acetylsalicylic Acid (Aspirin, BAYE4465)
n=1949 Days
Subjects received 1 tablet of enteric-coated acetylsalicylic acid \[100 milligram (mg)\] orally once daily.
|
Placebo
n=1949 Days
Subjects received 1 tablets of matching placebo orally once daily.
|
|---|---|---|
|
Time to the First Occurrence of the Composite Outcome of Cardiovascular Death, MI, or Stroke (Ischemic, Hemorrhagic, or Unknown)
Days until 1% subjects had an efficacy event
|
678 Days
|
522 Days
|
|
Time to the First Occurrence of the Composite Outcome of Cardiovascular Death, MI, or Stroke (Ischemic, Hemorrhagic, or Unknown)
Days until 2% subjects had an efficacy event
|
1167 Days
|
1053 Days
|
|
Time to the First Occurrence of the Composite Outcome of Cardiovascular Death, MI, or Stroke (Ischemic, Hemorrhagic, or Unknown)
Days until 3% subjects had an efficacy event
|
1599 Days
|
1501 Days
|
|
Time to the First Occurrence of the Composite Outcome of Cardiovascular Death, MI, or Stroke (Ischemic, Hemorrhagic, or Unknown)
Days until 4% subjects had an efficacy event
|
1949 Days
|
1930 Days
|
SECONDARY outcome
Timeframe: Until follow-up (approximately 6 years)Population: ITT
The time to event was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.
Outcome measures
| Measure |
Acetylsalicylic Acid (Aspirin, BAYE4465)
n=2128 Days
Subjects received 1 tablet of enteric-coated acetylsalicylic acid \[100 milligram (mg)\] orally once daily.
|
Placebo
n=2128 Days
Subjects received 1 tablets of matching placebo orally once daily.
|
|---|---|---|
|
Time to the First Occurrence of the Individual Components of the Primary: Non-fatal MI, Total MI, Non-fatal Stroke, Total Stroke, Cardiovascular Death, UA and TIA
Days until 1% subjects had non-fatal MI
|
1309 Days
|
1085 Days
|
|
Time to the First Occurrence of the Individual Components of the Primary: Non-fatal MI, Total MI, Non-fatal Stroke, Total Stroke, Cardiovascular Death, UA and TIA
Days until 2% subjects had non-fatal MI
|
NA Days
Not applicable (NA) indicates that these milestones did not occur before completion of the study.
|
2121 Days
|
|
Time to the First Occurrence of the Individual Components of the Primary: Non-fatal MI, Total MI, Non-fatal Stroke, Total Stroke, Cardiovascular Death, UA and TIA
Days until 1% subjects had total MI
|
1216 Days
|
1014 Days
|
|
Time to the First Occurrence of the Individual Components of the Primary: Non-fatal MI, Total MI, Non-fatal Stroke, Total Stroke, Cardiovascular Death, UA and TIA
Days until 2% subjects had total MI
|
2128 Days
|
1906 Days
|
|
Time to the First Occurrence of the Individual Components of the Primary: Non-fatal MI, Total MI, Non-fatal Stroke, Total Stroke, Cardiovascular Death, UA and TIA
Days until 1% subjects had non-fatal stroke
|
1576 Days
|
1650 Days
|
|
Time to the First Occurrence of the Individual Components of the Primary: Non-fatal MI, Total MI, Non-fatal Stroke, Total Stroke, Cardiovascular Death, UA and TIA
Days until 2% subjects had non-fatal stroke
|
NA Days
Not applicable (NA) indicates that these milestones did not occur before completion of the study.
|
NA Days
Not applicable (NA) indicates that these milestones did not occur before completion of the study.
|
|
Time to the First Occurrence of the Individual Components of the Primary: Non-fatal MI, Total MI, Non-fatal Stroke, Total Stroke, Cardiovascular Death, UA and TIA
Days until 1% subjects had total stroke
|
1543 Days
|
1627 Days
|
|
Time to the First Occurrence of the Individual Components of the Primary: Non-fatal MI, Total MI, Non-fatal Stroke, Total Stroke, Cardiovascular Death, UA and TIA
Days until 2% subjects had total stroke
|
NA Days
Not applicable (NA) indicates that these milestones did not occur before completion of the study.
|
NA Days
Not applicable (NA) indicates that these milestones did not occur before completion of the study.
|
|
Time to the First Occurrence of the Individual Components of the Primary: Non-fatal MI, Total MI, Non-fatal Stroke, Total Stroke, Cardiovascular Death, UA and TIA
Days until 1% subjects had cardiovascular death
|
NA Days
Not applicable (NA) indicates that these milestones did not occur before completion of the study.
|
NA Days
Not applicable (NA) indicates that these milestones did not occur before completion of the study.
|
|
Time to the First Occurrence of the Individual Components of the Primary: Non-fatal MI, Total MI, Non-fatal Stroke, Total Stroke, Cardiovascular Death, UA and TIA
Days until 2% subjects had cardiovascular death
|
NA Days
Not applicable (NA) indicates that these milestones did not occur before completion of the study.
|
NA Days
Not applicable (NA) indicates that these milestones did not occur before completion of the study.
|
|
Time to the First Occurrence of the Individual Components of the Primary: Non-fatal MI, Total MI, Non-fatal Stroke, Total Stroke, Cardiovascular Death, UA and TIA
Days until 1% subjects had UA
|
NA Days
Not applicable (NA) indicates that these milestones did not occur before completion of the study.
|
NA Days
Not applicable (NA) indicates that these milestones did not occur before completion of the study.
|
|
Time to the First Occurrence of the Individual Components of the Primary: Non-fatal MI, Total MI, Non-fatal Stroke, Total Stroke, Cardiovascular Death, UA and TIA
Days until 2% subjects had UA
|
NA Days
Not applicable (NA) indicates that these milestones did not occur before completion of the study.
|
NA Days
Not applicable (NA) indicates that these milestones did not occur before completion of the study.
|
|
Time to the First Occurrence of the Individual Components of the Primary: Non-fatal MI, Total MI, Non-fatal Stroke, Total Stroke, Cardiovascular Death, UA and TIA
Days until 1% subjects had TIA
|
NA Days
Not applicable (NA) indicates that these milestones did not occur before completion of the study.
|
NA Days
Not applicable (NA) indicates that these milestones did not occur before completion of the study.
|
|
Time to the First Occurrence of the Individual Components of the Primary: Non-fatal MI, Total MI, Non-fatal Stroke, Total Stroke, Cardiovascular Death, UA and TIA
Days until 2% subjects had TIA
|
NA Days
Not applicable (NA) indicates that these milestones did not occur before completion of the study.
|
NA Days
Not applicable (NA) indicates that these milestones did not occur before completion of the study..
|
SECONDARY outcome
Timeframe: Until follow-up (approximately 6 years)Population: ITT
The time to event was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses.
Outcome measures
| Measure |
Acetylsalicylic Acid (Aspirin, BAYE4465)
n=1970 Days
Subjects received 1 tablet of enteric-coated acetylsalicylic acid \[100 milligram (mg)\] orally once daily.
|
Placebo
n=1970 Days
Subjects received 1 tablets of matching placebo orally once daily.
|
|---|---|---|
|
Time to All-cause Mortality, the First Occurrence of All Cancers Excluding Non-melanoma Skin Cancer (NMSC) and the First Occurrence of Colon Cancer
Days until 1% subjects had all-cause mortality
|
838 Days
|
938 Days
|
|
Time to All-cause Mortality, the First Occurrence of All Cancers Excluding Non-melanoma Skin Cancer (NMSC) and the First Occurrence of Colon Cancer
Days until 2% subjects had all-cause mortality
|
1493 Days
|
1460 Days
|
|
Time to All-cause Mortality, the First Occurrence of All Cancers Excluding Non-melanoma Skin Cancer (NMSC) and the First Occurrence of Colon Cancer
Days until 3% subjects had all-cause mortality
|
1970 Days
|
1963 Days
|
|
Time to All-cause Mortality, the First Occurrence of All Cancers Excluding Non-melanoma Skin Cancer (NMSC) and the First Occurrence of Colon Cancer
Days until 4% subjects had all-cause mortality
|
NA Days
Not applicable (NA) indicates that these milestones did not occur before completion of the study.
|
NA Days
Not applicable (NA) indicates that these milestones did not occur before completion of the study.
|
|
Time to All-cause Mortality, the First Occurrence of All Cancers Excluding Non-melanoma Skin Cancer (NMSC) and the First Occurrence of Colon Cancer
Days until 1% subjects had all cancer excl. NMSC
|
374 Days
|
420 Days
|
|
Time to All-cause Mortality, the First Occurrence of All Cancers Excluding Non-melanoma Skin Cancer (NMSC) and the First Occurrence of Colon Cancer
Days until 2% subjects had all cancer excl. NMSC
|
849 Days
|
805 Days
|
|
Time to All-cause Mortality, the First Occurrence of All Cancers Excluding Non-melanoma Skin Cancer (NMSC) and the First Occurrence of Colon Cancer
Days until 3% subjects had all cancer excl. NMSC
|
1164 Days
|
1276 Days
|
|
Time to All-cause Mortality, the First Occurrence of All Cancers Excluding Non-melanoma Skin Cancer (NMSC) and the First Occurrence of Colon Cancer
Days until 4% subjects had all cancer excl. NMSC
|
1542 Days
|
1751 Days
|
|
Time to All-cause Mortality, the First Occurrence of All Cancers Excluding Non-melanoma Skin Cancer (NMSC) and the First Occurrence of Colon Cancer
Days until 1% subjects had colon cancer
|
NA Days
Not applicable (NA) indicates that these milestones did not occur before completion of the study.
|
NA Days
Not applicable (NA) indicates that these milestones did not occur before completion of the study.
|
|
Time to All-cause Mortality, the First Occurrence of All Cancers Excluding Non-melanoma Skin Cancer (NMSC) and the First Occurrence of Colon Cancer
Days until 2% subjects had colon cancer
|
NA Days
Not applicable (NA) indicates that these milestones did not occur before completion of the study.
|
NA Days
Not applicable (NA) indicates that these milestones did not occur before completion of the study..
|
|
Time to All-cause Mortality, the First Occurrence of All Cancers Excluding Non-melanoma Skin Cancer (NMSC) and the First Occurrence of Colon Cancer
Days until 3% subjects had colon cancer
|
NA Days
Not applicable (NA) indicates that these milestones did not occur before completion of the study.
|
NA Days
Not applicable (NA) indicates that these milestones did not occur before completion of the study.
|
|
Time to All-cause Mortality, the First Occurrence of All Cancers Excluding Non-melanoma Skin Cancer (NMSC) and the First Occurrence of Colon Cancer
Days until 4% subjects had colon cancer
|
NA Days
Not applicable (NA) indicates that these milestones did not occur before completion of the study.
|
NA Days
Not applicable (NA) indicates that these milestones did not occur before completion of the study..
|
SECONDARY outcome
Timeframe: Until follow-up (approximately 6 years)Population: ITT
Outcome measures
| Measure |
Acetylsalicylic Acid (Aspirin, BAYE4465)
n=6270 Participants
Subjects received 1 tablet of enteric-coated acetylsalicylic acid \[100 milligram (mg)\] orally once daily.
|
Placebo
n=6276 Participants
Subjects received 1 tablets of matching placebo orally once daily.
|
|---|---|---|
|
Incidence of All-cause Mortality, All Cancers Excluding Non-melanoma Skin Cancer and Colon Cancer
all-cause mortality
|
2.55 Percentage of participants
|
2.57 Percentage of participants
|
|
Incidence of All-cause Mortality, All Cancers Excluding Non-melanoma Skin Cancer and Colon Cancer
all cancers excluding non-melanoma skin cancer
|
4.02 Percentage of participants
|
3.76 Percentage of participants
|
|
Incidence of All-cause Mortality, All Cancers Excluding Non-melanoma Skin Cancer and Colon Cancer
colon cancer
|
0.48 Percentage of participants
|
0.41 Percentage of participants
|
SECONDARY outcome
Timeframe: Until follow-up (approximately 6 years)Population: ITT
The percentages of subjects with the efficacy endpoints of confirmed MI, stroke, cardiovascular death, UA and TIA are reported separately. \*all other CV death without fatal MI and fatal stroke
Outcome measures
| Measure |
Acetylsalicylic Acid (Aspirin, BAYE4465)
n=6270 Participants
Subjects received 1 tablet of enteric-coated acetylsalicylic acid \[100 milligram (mg)\] orally once daily.
|
Placebo
n=6276 Participants
Subjects received 1 tablets of matching placebo orally once daily.
|
|---|---|---|
|
Incidence of Confirmed MI, Stroke, Cardiovascular Death, UA, and TIA Separately
MI
|
1.52 Percentage of participants
|
1.78 Percentage of participants
|
|
Incidence of Confirmed MI, Stroke, Cardiovascular Death, UA, and TIA Separately
stroke
|
1.20 Percentage of participants
|
1.07 Percentage of participants
|
|
Incidence of Confirmed MI, Stroke, Cardiovascular Death, UA, and TIA Separately
CV death*
|
0.61 Percentage of participants
|
0.62 Percentage of participants
|
|
Incidence of Confirmed MI, Stroke, Cardiovascular Death, UA, and TIA Separately
UA
|
0.32 Percentage of participants
|
0.32 Percentage of participants
|
|
Incidence of Confirmed MI, Stroke, Cardiovascular Death, UA, and TIA Separately
TIA
|
0.67 Percentage of participants
|
0.72 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Until follow-up (approximate 6 years)Population: ITT
Outcome measures
| Measure |
Acetylsalicylic Acid (Aspirin, BAYE4465)
n=6270 Participants
Subjects received 1 tablet of enteric-coated acetylsalicylic acid \[100 milligram (mg)\] orally once daily.
|
Placebo
n=6276 Participants
Subjects received 1 tablets of matching placebo orally once daily.
|
|---|---|---|
|
Number of Subjects With Adjudicated GI Bleeding by Severity
Total
|
61 Participants
|
29 Participants
|
|
Number of Subjects With Adjudicated GI Bleeding by Severity
Mild
|
42 Participants
|
22 Participants
|
|
Number of Subjects With Adjudicated GI Bleeding by Severity
Moderate
|
15 Participants
|
5 Participants
|
|
Number of Subjects With Adjudicated GI Bleeding by Severity
Severe
|
4 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Until follow-up (approximate 6 years)Population: ITT
Outcome measures
| Measure |
Acetylsalicylic Acid (Aspirin, BAYE4465)
n=6270 Participants
Subjects received 1 tablet of enteric-coated acetylsalicylic acid \[100 milligram (mg)\] orally once daily.
|
Placebo
n=6276 Participants
Subjects received 1 tablets of matching placebo orally once daily.
|
|---|---|---|
|
Incidence of Composite Outcomes and Non-fatal MI
MI, stroke, CV death, UA or TIA
|
4.29 Percentage of participants
|
4.48 Percentage of participants
|
|
Incidence of Composite Outcomes and Non-fatal MI
MI, stroke or CV death
|
3.32 Percentage of participants
|
3.47 Percentage of participants
|
|
Incidence of Composite Outcomes and Non-fatal MI
non-fatal MI
|
1.40 Percentage of participants
|
1.56 Percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Until follow-up (approximate 6 years)Population: Per-protocol (PP) group (N=7702) consists of all patients who had no protocol violation.
\*all other CV death without fatal MI and fatal stroke.
Outcome measures
| Measure |
Acetylsalicylic Acid (Aspirin, BAYE4465)
n=3790 Participants
Subjects received 1 tablet of enteric-coated acetylsalicylic acid \[100 milligram (mg)\] orally once daily.
|
Placebo
n=3912 Participants
Subjects received 1 tablets of matching placebo orally once daily.
|
|---|---|---|
|
Incidence of Composite Outcomes and Individual Outcomes in Per-protocol Population
MI, stroke, CV death, UA or TIA
|
3.40 Percentage of participants
|
4.19 Percentage of participants
|
|
Incidence of Composite Outcomes and Individual Outcomes in Per-protocol Population
MI, stroke or CV death
|
2.72 Percentage of participants
|
3.45 Percentage of participants
|
|
Incidence of Composite Outcomes and Individual Outcomes in Per-protocol Population
MI
|
0.98 Percentage of participants
|
1.84 Percentage of participants
|
|
Incidence of Composite Outcomes and Individual Outcomes in Per-protocol Population
Non-fatal MI
|
0.84 Percentage of participants
|
1.53 Percentage of participants
|
|
Incidence of Composite Outcomes and Individual Outcomes in Per-protocol Population
Stroke
|
1.06 Percentage of participants
|
0.95 Percentage of participants
|
|
Incidence of Composite Outcomes and Individual Outcomes in Per-protocol Population
CV death*
|
0.69 Percentage of participants
|
0.66 Percentage of participants
|
|
Incidence of Composite Outcomes and Individual Outcomes in Per-protocol Population
UA
|
0.21 Percentage of participants
|
0.28 Percentage of participants
|
|
Incidence of Composite Outcomes and Individual Outcomes in Per-protocol Population
TIA
|
0.50 Percentage of participants
|
0.49 Percentage of participants
|
|
Incidence of Composite Outcomes and Individual Outcomes in Per-protocol Population
All-cause mortality
|
2.85 Percentage of participants
|
2.58 Percentage of participants
|
Adverse Events
Placebo
Serious events: 1311 serious events
Other events: 5053 other events
Deaths: 0 deaths
Acetylsalicylic Acid
Serious events: 1266 serious events
Other events: 5059 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=6276 participants at risk
Subjects received 1 tablets of matching placebo orally once daily.
|
Acetylsalicylic Acid
n=6270 participants at risk
Subjects received 1 tablet of enteric-coated acetylsalicylic acid \[100 milligram (mg)\] orally one daily.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Encephalitis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Renal and urinary disorders
End stage renal disease
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Endocarditis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Blood and lymphatic system disorders
Abdominal lymphadenopathy
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.16%
10/6276 • Number of events 11 • Until follow-up (approximately 6 years)
|
0.18%
11/6270 • Number of events 11 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Abdominal sepsis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Accident at work
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Acute coronary syndrome
|
0.19%
12/6276 • Number of events 12 • Until follow-up (approximately 6 years)
|
0.16%
10/6270 • Number of events 10 • Until follow-up (approximately 6 years)
|
|
Skin and subcutaneous tissue disorders
Acute febrile neutrophilic dermatosis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.11%
7/6276 • Number of events 7 • Until follow-up (approximately 6 years)
|
0.13%
8/6270 • Number of events 8 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Acute left ventricular failure
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Acute myocardial infarction
|
0.92%
58/6276 • Number of events 58 • Until follow-up (approximately 6 years)
|
0.69%
43/6270 • Number of events 44 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.10%
6/6276 • Number of events 6 • Until follow-up (approximately 6 years)
|
0.10%
6/6270 • Number of events 6 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenolymphoma
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal gland cancer metastatic
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenocortical carcinoma
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Psychiatric disorders
Agitated depression
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Psychiatric disorders
Alcohol abuse
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Hepatobiliary disorders
Alcoholic liver disease
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Eye disorders
Amaurosis fugax
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ameloblastoma
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Amnesia
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.06%
4/6276 • Number of events 4 • Until follow-up (approximately 6 years)
|
0.10%
6/6270 • Number of events 6 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Anal abscess
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Anal fistula
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Anal fistula infection
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Angina pectoris
|
0.22%
14/6276 • Number of events 15 • Until follow-up (approximately 6 years)
|
0.32%
20/6270 • Number of events 20 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Angina unstable
|
0.30%
19/6276 • Number of events 20 • Until follow-up (approximately 6 years)
|
0.24%
15/6270 • Number of events 17 • Until follow-up (approximately 6 years)
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.14%
9/6276 • Number of events 9 • Until follow-up (approximately 6 years)
|
0.21%
13/6270 • Number of events 13 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Aortic aneurysm
|
0.10%
6/6276 • Number of events 6 • Until follow-up (approximately 6 years)
|
0.16%
10/6270 • Number of events 10 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Aortic dilatation
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Aortic dissection
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Aortic stenosis
|
0.06%
4/6276 • Number of events 4 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Aortic valve calcification
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Aortic valve disease
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Aortic valve disease mixed
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Aortic valve incompetence
|
0.06%
4/6276 • Number of events 4 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Aortic valve stenosis
|
0.08%
5/6276 • Number of events 5 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Appendicitis
|
0.14%
9/6276 • Number of events 10 • Until follow-up (approximately 6 years)
|
0.14%
9/6270 • Number of events 9 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Appendicitis perforated
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Arterial bypass occlusion
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Arterial rupture
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Investigations
Arteriogram coronary
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Arteriosclerosis
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Arteriospasm coronary
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.16%
10/6276 • Number of events 10 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.10%
6/6276 • Number of events 6 • Until follow-up (approximately 6 years)
|
0.10%
6/6270 • Number of events 7 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Arthritis bacterial
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Arthritis infective
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Surgical and medical procedures
Arthrodesis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Atrial fibrillation
|
0.64%
40/6276 • Number of events 41 • Until follow-up (approximately 6 years)
|
0.59%
37/6270 • Number of events 39 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Atrial flutter
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Atrial thrombosis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Atrioventricular block complete
|
0.06%
4/6276 • Number of events 4 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.13%
8/6276 • Number of events 8 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Atypical fibroxanthoma
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Axonal neuropathy
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma stage IV
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell unclassifiable lymphoma high grade
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.13%
8/6276 • Number of events 9 • Until follow-up (approximately 6 years)
|
0.10%
6/6270 • Number of events 6 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.11%
7/6276 • Number of events 7 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Basal ganglia haemorrhage
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Basilar artery aneurysm
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basosquamous carcinoma of skin
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign anorectal neoplasm
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign lung neoplasm
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign mediastinal neoplasm
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of testis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumour
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign pancreatic neoplasm
|
0.03%
2/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.32%
20/6276 • Number of events 20 • Until follow-up (approximately 6 years)
|
0.16%
10/6270 • Number of events 10 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign salivary gland neoplasm
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Hepatobiliary disorders
Bile duct stone
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.06%
4/6270 • Number of events 4 • Until follow-up (approximately 6 years)
|
|
Hepatobiliary disorders
Biliary cirrhosis primary
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Hepatobiliary disorders
Biliary colic
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Hepatobiliary disorders
Biliary cyst
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Hepatobiliary disorders
Biliary fistula
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Investigations
Biopsy prostate
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.11%
7/6276 • Number of events 7 • Until follow-up (approximately 6 years)
|
0.10%
6/6270 • Number of events 6 • Until follow-up (approximately 6 years)
|
|
Renal and urinary disorders
Bladder diverticulum
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Renal and urinary disorders
Bladder neck sclerosis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.06%
4/6270 • Number of events 4 • Until follow-up (approximately 6 years)
|
|
Renal and urinary disorders
Bladder outlet obstruction
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder papilloma
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Renal and urinary disorders
Bladder sphincter atony
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.16%
10/6276 • Number of events 12 • Until follow-up (approximately 6 years)
|
0.14%
9/6270 • Number of events 10 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma metastatic
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma recurrent
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma stage I
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Bleeding varicose vein
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Investigations
Blood pressure increased
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Bone tuberculosis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Bradycardia
|
0.06%
4/6276 • Number of events 4 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer metastatic
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Brain injury
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Brain stem infarction
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Brain stem stroke
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.11%
7/6276 • Number of events 7 • Until follow-up (approximately 6 years)
|
0.16%
10/6270 • Number of events 10 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.06%
4/6270 • Number of events 4 • Until follow-up (approximately 6 years)
|
|
Reproductive system and breast disorders
Breast enlargement
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast neoplasm
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Bronchitis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Bundle branch block right
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.06%
4/6270 • Number of events 4 • Until follow-up (approximately 6 years)
|
|
Renal and urinary disorders
Calculus bladder
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the caecum
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Cardiac arrest
|
0.14%
9/6276 • Number of events 9 • Until follow-up (approximately 6 years)
|
0.06%
4/6270 • Number of events 4 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Cardiac disorder
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Cardiac failure
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.11%
7/6270 • Number of events 7 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Cardiac failure acute
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Cardiac failure chronic
|
0.06%
4/6276 • Number of events 4 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Cardiac failure congestive
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Cardiogenic shock
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Carotid artery disease
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Carotid artery occlusion
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Carotid artery stenosis
|
0.14%
9/6276 • Number of events 9 • Until follow-up (approximately 6 years)
|
0.08%
5/6270 • Number of events 5 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.03%
2/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Eye disorders
Cataract
|
0.08%
5/6276 • Number of events 5 • Until follow-up (approximately 6 years)
|
0.13%
8/6270 • Number of events 10 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Cauda equina syndrome
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Cellulitis
|
0.13%
8/6276 • Number of events 8 • Until follow-up (approximately 6 years)
|
0.10%
6/6270 • Number of events 6 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Cellulitis orbital
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system lymphoma
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Cerebellar infarction
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Cerebral circulatory failure
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Cerebral haematoma
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Cerebral infarction
|
0.08%
5/6276 • Number of events 5 • Until follow-up (approximately 6 years)
|
0.13%
8/6270 • Number of events 9 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Cerebral ischaemia
|
0.06%
4/6276 • Number of events 4 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.14%
9/6276 • Number of events 9 • Until follow-up (approximately 6 years)
|
0.16%
10/6270 • Number of events 10 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Cervical cord compression
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Cervical myelopathy
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Cervical radiculopathy
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Eye disorders
Chalazion
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Change of bowel habit
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
General disorders
Chest discomfort
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
General disorders
Chest pain
|
0.30%
19/6276 • Number of events 19 • Until follow-up (approximately 6 years)
|
0.37%
23/6270 • Number of events 24 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Chlamydial infection
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Hepatobiliary disorders
Cholecystitis
|
0.13%
8/6276 • Number of events 9 • Until follow-up (approximately 6 years)
|
0.21%
13/6270 • Number of events 13 • Until follow-up (approximately 6 years)
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.13%
8/6276 • Number of events 8 • Until follow-up (approximately 6 years)
|
0.11%
7/6270 • Number of events 7 • Until follow-up (approximately 6 years)
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Cholecystitis infective
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.27%
17/6276 • Number of events 17 • Until follow-up (approximately 6 years)
|
0.38%
24/6270 • Number of events 24 • Until follow-up (approximately 6 years)
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chondroma
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Choroid melanoma
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Chronic inflammatory demyelinating polyradiculoneuropathy
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.06%
4/6276 • Number of events 5 • Until follow-up (approximately 6 years)
|
0.06%
4/6270 • Number of events 5 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.14%
9/6276 • Number of events 9 • Until follow-up (approximately 6 years)
|
0.13%
8/6270 • Number of events 11 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Circulatory collapse
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.06%
4/6270 • Number of events 4 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Colitis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.08%
5/6276 • Number of events 6 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.10%
6/6276 • Number of events 6 • Until follow-up (approximately 6 years)
|
0.22%
14/6270 • Number of events 14 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.06%
4/6270 • Number of events 4 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Colon dysplasia
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Colonic abscess
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer metastatic
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Reproductive system and breast disorders
Colpocele
|
0.02%
1/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Psychiatric disorders
Completed suicide
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Complex partial seizures
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Concussion
|
0.05%
3/6276 • Number of events 4 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.10%
6/6270 • Number of events 6 • Until follow-up (approximately 6 years)
|
|
Congenital, familial and genetic disorders
Congenital cystic kidney disease
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Congenital, familial and genetic disorders
Congenital urinary tract obstruction
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Constipation
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.03%
2/6276 • Number of events 4 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Eye disorders
Corneal degeneration
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Eye disorders
Corneal disorder
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Coronary artery disease
|
0.97%
61/6276 • Number of events 63 • Until follow-up (approximately 6 years)
|
0.73%
46/6270 • Number of events 46 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Coronary artery occlusion
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Coronary artery stenosis
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Coronary ostial stenosis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Cubital tunnel syndrome
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Cystitis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
General disorders
Death
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Deep vein thrombosis
|
0.13%
8/6276 • Number of events 8 • Until follow-up (approximately 6 years)
|
0.08%
5/6270 • Number of events 5 • Until follow-up (approximately 6 years)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.06%
4/6270 • Number of events 4 • Until follow-up (approximately 6 years)
|
|
Psychiatric disorders
Delirium
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Dementia
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Demyelinating polyneuropathy
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Surgical and medical procedures
Dental operation
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Psychiatric disorders
Depression
|
0.06%
4/6276 • Number of events 6 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Product Issues
Device dislocation
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Product Issues
Device loosening
|
0.06%
4/6276 • Number of events 4 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Product Issues
Device malfunction
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Product Issues
Device occlusion
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Device related infection
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.02%
1/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma stage III
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Diverticulitis
|
0.11%
7/6276 • Number of events 8 • Until follow-up (approximately 6 years)
|
0.08%
5/6270 • Number of events 5 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Diverticulitis intestinal haemorrhagic
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.06%
4/6270 • Number of events 4 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Dizziness
|
0.10%
6/6276 • Number of events 6 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Dressler's syndrome
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Immune system disorders
Drug hypersensitivity
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Dry gangrene
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to pleura
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Duodenitis
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.08%
5/6276 • Number of events 5 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Dural abscess
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.08%
5/6276 • Number of events 6 • Until follow-up (approximately 6 years)
|
0.10%
6/6270 • Number of events 6 • Until follow-up (approximately 6 years)
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Ear infection
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Surgical and medical procedures
Elbow operation
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Investigations
Electrocardiogram abnormal
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Embolic cerebral infarction
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Endocarditis bacterial
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Eye disorders
Endocrine ophthalmopathy
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Reproductive system and breast disorders
Epididymal cyst
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Epididymitis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Epilepsy
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.06%
4/6276 • Number of events 4 • Until follow-up (approximately 6 years)
|
0.16%
10/6270 • Number of events 11 • Until follow-up (approximately 6 years)
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Erysipelas
|
0.02%
1/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Extradural abscess
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extraskeletal myxoid chondrosarcoma
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Extrasystoles
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Eye disorders
Eye disorder
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Eye disorders
Eyelid dermatochalasis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Eyelid injury
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Eye disorders
Eyelid ptosis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Facet joint syndrome
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.05%
3/6276 • Number of events 4 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Faecaloma
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Fall
|
0.11%
7/6276 • Number of events 8 • Until follow-up (approximately 6 years)
|
0.06%
4/6270 • Number of events 4 • Until follow-up (approximately 6 years)
|
|
Congenital, familial and genetic disorders
Familial tremor
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.02%
1/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
General disorders
Feeling abnormal
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Femoral hernia
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.14%
9/6276 • Number of events 10 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.10%
6/6276 • Number of events 6 • Until follow-up (approximately 6 years)
|
0.06%
4/6270 • Number of events 4 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroma
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Food poisoning
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.03%
2/6276 • Number of events 4 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 4 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Fracture nonunion
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Fractured ischium
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Hepatobiliary disorders
Gallbladder enlargement
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Hepatobiliary disorders
Gallbladder perforation
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Gangrene
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Gas poisoning
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.02%
1/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Gastric polyps
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.06%
4/6270 • Number of events 4 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Gastritis
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Gastroenteritis
|
0.06%
4/6276 • Number of events 4 • Until follow-up (approximately 6 years)
|
0.10%
6/6270 • Number of events 6 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Gastroenteritis viral
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal cancer metastatic
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.21%
13/6270 • Number of events 13 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal neoplasm
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal cancer
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Eye disorders
Glaucoma
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.06%
4/6270 • Number of events 4 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glottis carcinoma
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Endocrine disorders
Goitre
|
0.06%
4/6276 • Number of events 4 • Until follow-up (approximately 6 years)
|
0.10%
6/6270 • Number of events 6 • Until follow-up (approximately 6 years)
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Granulomatosis with polyangiitis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Haematemesis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Haematochezia
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Haematoma
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Renal and urinary disorders
Haematuria
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.11%
7/6270 • Number of events 7 • Until follow-up (approximately 6 years)
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Congenital, familial and genetic disorders
Haemophilia
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Haemorrhagic erosive gastritis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.06%
4/6276 • Number of events 4 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.06%
4/6270 • Number of events 4 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Haemorrhoids thrombosed
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.03%
2/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Head injury
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.08%
5/6270 • Number of events 5 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Headache
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Hemianaesthesia
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.02%
1/6276 • Number of events 4 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
General disorders
Hernia
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Herpes zoster infection neurological
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Herpes zoster meningoencephalitis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.06%
4/6276 • Number of events 4 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Surgical and medical procedures
Hip surgery
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.18%
11/6276 • Number of events 12 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.03%
2/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Renal and urinary disorders
Hydronephrosis
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Endocrine disorders
Hyperparathyroidism
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Hypertension
|
0.13%
8/6276 • Number of events 8 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Hypertensive crisis
|
0.18%
11/6276 • Number of events 12 • Until follow-up (approximately 6 years)
|
0.13%
8/6270 • Number of events 10 • Until follow-up (approximately 6 years)
|
|
Endocrine disorders
Hyperthyroidism
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Hypotension
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Hypovolaemic shock
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Ileus
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Iliac artery occlusion
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Ilium fracture
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
General disorders
Impaired healing
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Incision site ulcer
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Renal and urinary disorders
Incontinence
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Infection
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Infectious pleural effusion
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.06%
4/6276 • Number of events 5 • Until follow-up (approximately 6 years)
|
0.11%
7/6270 • Number of events 11 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Inflammatory bowel disease
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.49%
31/6276 • Number of events 32 • Until follow-up (approximately 6 years)
|
0.56%
35/6270 • Number of events 35 • Until follow-up (approximately 6 years)
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Inguinal hernia strangulated
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
General disorders
Injection site injury
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Injury
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Ear and labyrinth disorders
Inner ear disorder
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Insulinoma
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Intercostal neuralgia
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Intermittent claudication
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc compression
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.13%
8/6276 • Number of events 8 • Until follow-up (approximately 6 years)
|
0.10%
6/6270 • Number of events 8 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Intestinal fibrosis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 4 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Intracranial aneurysm
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial haemangioma
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraocular melanoma
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.08%
5/6270 • Number of events 5 • Until follow-up (approximately 6 years)
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Ischaemic stroke
|
0.30%
19/6276 • Number of events 19 • Until follow-up (approximately 6 years)
|
0.35%
22/6270 • Number of events 22 • Until follow-up (approximately 6 years)
|
|
Hepatobiliary disorders
Jaundice
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Surgical and medical procedures
Joint dislocation reduction
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Kidney contusion
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Kidney infection
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.06%
4/6276 • Number of events 4 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Surgical and medical procedures
Knee operation
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Labile hypertension
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Labyrinthitis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Laceration
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Lacunar infarction
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.10%
6/6270 • Number of events 6 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Lacunar stroke
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.06%
4/6270 • Number of events 6 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer metastatic
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal squamous cell carcinoma
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyoma
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna recurrent
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Leriche syndrome
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Leukoplakia oral
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip squamous cell carcinoma
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liposarcoma
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Investigations
Liver function test abnormal
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Loss of consciousness
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.06%
4/6270 • Number of events 4 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 4 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.03%
2/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Lower respiratory tract infection
|
0.06%
4/6276 • Number of events 4 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Renal and urinary disorders
Lower urinary tract symptoms
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.06%
4/6276 • Number of events 4 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 4 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.05%
3/6276 • Number of events 4 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage I
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.06%
4/6270 • Number of events 4 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified recurrent
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.16%
10/6270 • Number of events 10 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma metastatic
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis carcinomatosa
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Eye disorders
Macular fibrosis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Eye disorders
Macular hole
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Psychiatric disorders
Major depression
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
General disorders
Malaise
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Malignant hypertension
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.06%
4/6276 • Number of events 4 • Until follow-up (approximately 6 years)
|
0.14%
9/6270 • Number of events 9 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of ampulla of Vater
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of pleura metastatic
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of unknown primary site
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant nipple neoplasm
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal cyst
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
General disorders
Medical device pain
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Melaena
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanoma recurrent
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma benign
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Meningitis meningococcal
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Meningitis viral
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Meniscal degeneration
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.18%
11/6276 • Number of events 11 • Until follow-up (approximately 6 years)
|
0.16%
10/6270 • Number of events 10 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma malignant
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.06%
4/6270 • Number of events 4 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic bronchial carcinoma
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Migraine
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Mitral valve incompetence
|
0.06%
4/6276 • Number of events 4 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Mitral valve prolapse
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Mixed connective tissue disease
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mixed hepatocellular cholangiocarcinoma
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Morton's neuralgia
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Motor neurone disease
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Muscle abscess
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Congenital, familial and genetic disorders
Myocardial bridging
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Myocardial fibrosis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Myocardial infarction
|
0.61%
38/6276 • Number of events 38 • Until follow-up (approximately 6 years)
|
0.46%
29/6270 • Number of events 29 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Myocardial ischaemia
|
0.16%
10/6276 • Number of events 10 • Until follow-up (approximately 6 years)
|
0.11%
7/6270 • Number of events 7 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myxofibrosarcoma
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate hypertrophy
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Nausea
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm prostate
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Surgical and medical procedures
Nephrectomy
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.11%
7/6276 • Number of events 7 • Until follow-up (approximately 6 years)
|
0.10%
6/6270 • Number of events 7 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Neuralgic amyotrophy
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Neurodegenerative disorder
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma of the skin
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neurofibroma
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Renal and urinary disorders
Neurogenic bladder
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Neutropenic sepsis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma stage II
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
General disorders
Non-cardiac chest pain
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.10%
6/6276 • Number of events 6 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage IIIB
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage IV
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Metabolism and nutrition disorders
Obesity
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Congenital, familial and genetic disorders
Odontogenic cyst
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
General disorders
Oedema
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
General disorders
Oedema peripheral
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Oesophageal achalasia
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal cancer metastatic
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal squamous cell carcinoma
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Oesophageal ulcer haemorrhage
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Oesophagitis ulcerative
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Oral mucosal hypertrophy
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Orchitis
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
General disorders
Organ failure
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal squamous cell carcinoma
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Orthostatic intolerance
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.6%
103/6276 • Number of events 109 • Until follow-up (approximately 6 years)
|
1.7%
104/6270 • Number of events 114 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Osteochondritis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Osteosarcoma
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Otitis externa
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Otitis media chronic
|
0.02%
1/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian epithelial cancer metastatic
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Palpitations
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Pancreas infection
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.06%
4/6276 • Number of events 4 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Pancreatic pseudocyst
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.08%
5/6270 • Number of events 5 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Pancreatitis necrotising
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary cystadenoma lymphomatosum
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraproteinaemia
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Skin and subcutaneous tissue disorders
Parapsoriasis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Parkinson's disease
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Paronychia
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Surgical and medical procedures
Parotidectomy
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Partial seizures
|
0.03%
2/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Patellofemoral pain syndrome
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Product Issues
Patient-device incompatibility
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
General disorders
Performance status decreased
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Perihepatic abscess
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Perineal abscess
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.19%
12/6276 • Number of events 12 • Until follow-up (approximately 6 years)
|
0.08%
5/6270 • Number of events 6 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Peripheral artery occlusion
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Peripheral artery stenosis
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Peripheral arthritis
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Peripheral ischaemia
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
General disorders
Peripheral swelling
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Peripheral venous disease
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Peritonitis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.06%
4/6270 • Number of events 4 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Peritonsillar abscess
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Peritonsillitis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal hypertrophy
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Pharyngitis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Psychiatric disorders
Phobia
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Pilonidal cyst
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural calcification
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.06%
4/6276 • Number of events 4 • Until follow-up (approximately 6 years)
|
0.06%
4/6270 • Number of events 5 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Pleural infection
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleural mesothelioma
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleural mesothelioma malignant
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Pleuropericarditis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Pneumonia
|
0.30%
19/6276 • Number of events 19 • Until follow-up (approximately 6 years)
|
0.41%
26/6270 • Number of events 28 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Pneumonia influenzal
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Pneumonia legionella
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.08%
5/6276 • Number of events 5 • Until follow-up (approximately 6 years)
|
0.06%
4/6270 • Number of events 5 • Until follow-up (approximately 6 years)
|
|
Renal and urinary disorders
Pollakiuria
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.06%
4/6270 • Number of events 4 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Eye disorders
Polypoidal choroidal vasculopathy
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Post concussion syndrome
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Post procedural inflammation
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Post procedural myocardial infarction
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Postoperative wound infection
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Renal and urinary disorders
Prerenal failure
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Presyncope
|
0.08%
5/6276 • Number of events 5 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Prinzmetal angina
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.70%
44/6276 • Number of events 45 • Until follow-up (approximately 6 years)
|
0.94%
59/6270 • Number of events 59 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.06%
4/6270 • Number of events 4 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage 0
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage I
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage III
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.13%
8/6276 • Number of events 8 • Until follow-up (approximately 6 years)
|
0.08%
5/6270 • Number of events 5 • Until follow-up (approximately 6 years)
|
|
Reproductive system and breast disorders
Prostatic cyst
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Reproductive system and breast disorders
Prostatic disorder
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Surgical and medical procedures
Prostatic operation
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Reproductive system and breast disorders
Prostatism
|
0.03%
2/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.06%
4/6270 • Number of events 4 • Until follow-up (approximately 6 years)
|
|
Reproductive system and breast disorders
Prostatitis
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.06%
4/6270 • Number of events 4 • Until follow-up (approximately 6 years)
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Pseudomonal sepsis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary cavitation
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.25%
16/6276 • Number of events 16 • Until follow-up (approximately 6 years)
|
0.19%
12/6270 • Number of events 12 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.03%
2/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Pyelocystitis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Pyelonephritis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Pyelonephritis acute
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
General disorders
Pyrexia
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Quadriparesis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Radicular syndrome
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.11%
7/6276 • Number of events 7 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.10%
6/6276 • Number of events 6 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.06%
4/6276 • Number of events 4 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer metastatic
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Rectal fissure
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.10%
6/6270 • Number of events 6 • Until follow-up (approximately 6 years)
|
|
Reproductive system and breast disorders
Rectocele
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer metastatic
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Surgical and medical procedures
Removal of internal fixation
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.08%
5/6276 • Number of events 5 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Renal and urinary disorders
Renal colic
|
0.13%
8/6276 • Number of events 8 • Until follow-up (approximately 6 years)
|
0.13%
8/6270 • Number of events 8 • Until follow-up (approximately 6 years)
|
|
Renal and urinary disorders
Renal cyst
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 4 • Until follow-up (approximately 6 years)
|
|
Renal and urinary disorders
Renal cyst haemorrhage
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Renal and urinary disorders
Renal haematoma
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Renal and urinary disorders
Renal impairment
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Respiratory tract infection
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Eye disorders
Retinal artery embolism
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Eye disorders
Retinal artery occlusion
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Eye disorders
Retinal detachment
|
0.05%
3/6276 • Number of events 4 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Eye disorders
Retinal haemorrhage
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Eye disorders
Retinal tear
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Eye disorders
Retinal vein thrombosis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Retroperitoneal neoplasm
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Reversible ischaemic neurological deficit
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.03%
2/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Rhinitis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Skin and subcutaneous tissue disorders
Rhinophyma
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Right ventricular failure
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.06%
4/6276 • Number of events 4 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.21%
13/6276 • Number of events 13 • Until follow-up (approximately 6 years)
|
0.10%
6/6270 • Number of events 6 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Ruptured cerebral aneurysm
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Sciatica
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Scrotal abscess
|
0.02%
1/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Skin and subcutaneous tissue disorders
Sebaceous hyperplasia
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Seizure
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Sepsis
|
0.10%
6/6276 • Number of events 6 • Until follow-up (approximately 6 years)
|
0.06%
4/6270 • Number of events 5 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Septic shock
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Investigations
Serum ferritin increased
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Silent myocardial infarction
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Sinoatrial block
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sinonasal papilloma
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Sinus bradycardia
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Sinus node dysfunction
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Sinusitis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.10%
6/6276 • Number of events 6 • Until follow-up (approximately 6 years)
|
0.06%
4/6270 • Number of events 4 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.06%
4/6276 • Number of events 4 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine adenocarcinoma
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Soft tissue neoplasm
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.11%
7/6276 • Number of events 7 • Until follow-up (approximately 6 years)
|
0.06%
4/6270 • Number of events 4 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Spinal deformity
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Spinal disorder
|
0.02%
1/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.06%
4/6276 • Number of events 4 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Surgical and medical procedures
Spinal fusion surgery
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Spinal vascular disorder
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.02%
1/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the oral cavity
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Stomal hernia
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Eye disorders
Strabismus
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.10%
6/6270 • Number of events 6 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Subdiaphragmatic abscess
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
General disorders
Sudden cardiac death
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
General disorders
Sudden death
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Psychiatric disorders
Suicide attempt
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Superficial spreading melanoma stage unspecified
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Syncope
|
0.19%
12/6276 • Number of events 13 • Until follow-up (approximately 6 years)
|
0.11%
7/6270 • Number of events 7 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Synovial rupture
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
General disorders
Systemic inflammatory response syndrome
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Tachycardia paroxysmal
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Temporal arteritis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.08%
5/6276 • Number of events 5 • Until follow-up (approximately 6 years)
|
0.06%
4/6270 • Number of events 4 • Until follow-up (approximately 6 years)
|
|
Reproductive system and breast disorders
Testicular disorder
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Reproductive system and breast disorders
Testis discomfort
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Thalamic infarction
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.02%
1/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.06%
4/6270 • Number of events 4 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Throat cancer
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Thrombophlebitis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Thrombosed varicose vein
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Thrombosis mesenteric vessel
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thymoma
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer metastatic
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Endocrine disorders
Thyroid cyst
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Surgical and medical procedures
Thyroidectomy
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue cancer metastatic
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Torsade de pointes
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Endocrine disorders
Toxic nodular goitre
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Transient global amnesia
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Transient ischaemic attack
|
0.48%
30/6276 • Number of events 31 • Until follow-up (approximately 6 years)
|
0.41%
26/6270 • Number of events 27 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell cancer of the renal pelvis and ureter
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Surgical and medical procedures
Transurethral prostatectomy
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Surgical and medical procedures
Tympanoplasty
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.08%
5/6276 • Number of events 7 • Until follow-up (approximately 6 years)
|
0.13%
8/6270 • Number of events 8 • Until follow-up (approximately 6 years)
|
|
Congenital, familial and genetic disorders
Type IIa hyperlipidaemia
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.06%
4/6276 • Number of events 4 • Until follow-up (approximately 6 years)
|
0.08%
5/6270 • Number of events 5 • Until follow-up (approximately 6 years)
|
|
General disorders
Unevaluable event
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.06%
4/6276 • Number of events 4 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Renal and urinary disorders
Urethral pain
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urinary bladder adenoma
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Renal and urinary disorders
Urinary incontinence
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Renal and urinary disorders
Urinary retention
|
0.13%
8/6276 • Number of events 8 • Until follow-up (approximately 6 years)
|
0.10%
6/6270 • Number of events 7 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Urinary tract infection
|
0.11%
7/6276 • Number of events 7 • Until follow-up (approximately 6 years)
|
0.14%
9/6270 • Number of events 9 • Until follow-up (approximately 6 years)
|
|
Renal and urinary disorders
Urine flow decreased
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Urosepsis
|
0.06%
4/6276 • Number of events 4 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine neoplasm
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.05%
3/6270 • Number of events 3 • Until follow-up (approximately 6 years)
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Uveitis-glaucoma-hyphaema syndrome
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
VIIIth nerve lesion
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
VIth nerve paralysis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
VIth nerve paresis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Reproductive system and breast disorders
Vaginal haematoma
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.08%
5/6270 • Number of events 5 • Until follow-up (approximately 6 years)
|
|
Surgical and medical procedures
Vaginal prolapse repair
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Varicose vein
|
0.13%
8/6276 • Number of events 9 • Until follow-up (approximately 6 years)
|
0.08%
5/6270 • Number of events 5 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Vascular encephalopathy
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
General disorders
Vascular stent occlusion
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
General disorders
Vascular stent thrombosis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Vasculitis
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Vasculitis cerebral
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Venous thrombosis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Venous thrombosis limb
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Ventricular fibrillation
|
0.06%
4/6276 • Number of events 4 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Cardiac disorders
Ventricular tachycardia
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Ear and labyrinth disorders
Vertigo
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.03%
2/6276 • Number of events 2 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Vestibular neuronitis
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Viral infection
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Eye disorders
Vision blurred
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Visual field defect
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Eye disorders
Vitreous haemorrhage
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord disorder
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord leukoplakia
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord polyp
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Vomiting
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Investigations
Weight decreased
|
0.05%
3/6276 • Number of events 3 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Nervous system disorders
Wernicke's encephalopathy
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Investigations
White blood cell count increased
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Psychiatric disorders
Withdrawal syndrome
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/6276 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Wound infection
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.02%
1/6270 • Number of events 1 • Until follow-up (approximately 6 years)
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.03%
2/6270 • Number of events 2 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Yersinia infection
|
0.02%
1/6276 • Number of events 1 • Until follow-up (approximately 6 years)
|
0.00%
0/6270 • Until follow-up (approximately 6 years)
|
Other adverse events
| Measure |
Placebo
n=6276 participants at risk
Subjects received 1 tablets of matching placebo orally once daily.
|
Acetylsalicylic Acid
n=6270 participants at risk
Subjects received 1 tablet of enteric-coated acetylsalicylic acid \[100 milligram (mg)\] orally one daily.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.4%
653/6276 • Number of events 803 • Until follow-up (approximately 6 years)
|
10.1%
636/6270 • Number of events 816 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.0%
688/6276 • Number of events 908 • Until follow-up (approximately 6 years)
|
11.1%
695/6270 • Number of events 897 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Bronchitis
|
7.7%
482/6276 • Number of events 680 • Until follow-up (approximately 6 years)
|
8.2%
514/6270 • Number of events 741 • Until follow-up (approximately 6 years)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.9%
497/6276 • Number of events 601 • Until follow-up (approximately 6 years)
|
7.0%
442/6270 • Number of events 556 • Until follow-up (approximately 6 years)
|
|
Gastrointestinal disorders
Dyspepsia
|
5.8%
362/6276 • Number of events 419 • Until follow-up (approximately 6 years)
|
6.0%
374/6270 • Number of events 446 • Until follow-up (approximately 6 years)
|
|
Vascular disorders
Hypertension
|
8.2%
514/6276 • Number of events 578 • Until follow-up (approximately 6 years)
|
7.6%
478/6270 • Number of events 526 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Lower respiratory tract infection
|
6.7%
420/6276 • Number of events 703 • Until follow-up (approximately 6 years)
|
6.0%
377/6270 • Number of events 650 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Nasopharyngitis
|
6.5%
407/6276 • Number of events 524 • Until follow-up (approximately 6 years)
|
6.7%
421/6270 • Number of events 550 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
6.7%
423/6276 • Number of events 517 • Until follow-up (approximately 6 years)
|
7.5%
468/6270 • Number of events 548 • Until follow-up (approximately 6 years)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.7%
359/6276 • Number of events 406 • Until follow-up (approximately 6 years)
|
5.6%
354/6270 • Number of events 406 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Upper respiratory tract infection
|
5.9%
371/6276 • Number of events 491 • Until follow-up (approximately 6 years)
|
5.6%
348/6270 • Number of events 443 • Until follow-up (approximately 6 years)
|
|
Infections and infestations
Urinary tract infection
|
5.1%
321/6276 • Number of events 474 • Until follow-up (approximately 6 years)
|
5.8%
363/6270 • Number of events 549 • Until follow-up (approximately 6 years)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60