Trial Outcomes & Findings for CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes (NCT NCT01243424)
NCT ID: NCT01243424
Last Updated: 2020-01-07
Results Overview
The first occurrence of any of the following Clinical Event Committee (CEC) confirmed adjudicated components of the primary composite endpoint: CV death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI (excluding silent MI), or nonfatal stroke is presented.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
6103 participants
Primary outcome timeframe
From randomization until individual day of trial completion, up to 432 weeks
Results posted on
2020-01-07
Participant Flow
This multicentre, multinational, randomised, double-blind, double-dummy, parallel group,comparator-controlled trial compared Linagliptin versus (vs.) Glimepiride, predominantly on metformin background treatment in participants with type 2 diabetes mellitus (T2DM) at elevated cardiovascular (CV) risk receiving usual care.
All participants were screened for eligibility to participate in the trial. Participants attended specialist sites which would then ensure that all participants met all inclusion/exclusion criteria. Participants were not to be randomised to trial treatment if any one of the specific entry criteria were not met.
Participant milestones
| Measure |
Linagliptin
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
Glimepiride
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
|---|---|---|
|
Discontinuation From Study (Treated Set)
STARTED
|
3028
|
3014
|
|
Discontinuation From Study (Treated Set)
Patient Died (Other Cause Than CV Death)
|
123
|
146
|
|
Discontinuation From Study (Treated Set)
Treated
|
3023
|
3010
|
|
Discontinuation From Study (Treated Set)
COMPLETED
|
2899
|
2895
|
|
Discontinuation From Study (Treated Set)
NOT COMPLETED
|
129
|
119
|
|
Discontinuation From Treatment
STARTED
|
3028
|
3014
|
|
Discontinuation From Treatment
Treated
|
3023
|
3010
|
|
Discontinuation From Treatment
COMPLETED
|
1896
|
1832
|
|
Discontinuation From Treatment
NOT COMPLETED
|
1132
|
1182
|
Reasons for withdrawal
| Measure |
Linagliptin
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
Glimepiride
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
|---|---|---|
|
Discontinuation From Study (Treated Set)
Consent Withdrawn (Status Alive)
|
49
|
37
|
|
Discontinuation From Study (Treated Set)
Consent Withdrawn (Status Unknown)
|
14
|
12
|
|
Discontinuation From Study (Treated Set)
Site Closure (Status Alive)
|
15
|
22
|
|
Discontinuation From Study (Treated Set)
Site Closure (Status Unknown)
|
0
|
1
|
|
Discontinuation From Study (Treated Set)
LostToFollowUpfor3P-MACE(StatusAlive)
|
38
|
35
|
|
Discontinuation From Study (Treated Set)
LostToFollowUpfor3P-MACE(StatusUnknown)
|
8
|
8
|
|
Discontinuation From Study (Treated Set)
Not treated
|
5
|
4
|
|
Discontinuation From Treatment
Not treated
|
5
|
4
|
|
Discontinuation From Treatment
Adverse Event
|
457
|
523
|
|
Discontinuation From Treatment
Lack of Efficacy
|
61
|
41
|
|
Discontinuation From Treatment
Protocol Violation
|
46
|
47
|
|
Discontinuation From Treatment
Lost to Follow-up
|
24
|
28
|
|
Discontinuation From Treatment
Withdrawal by Subject
|
309
|
328
|
|
Discontinuation From Treatment
Other than listed above
|
230
|
211
|
Baseline Characteristics
CAROLINA: Cardiovascular Outcome Study of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Linagliptin
n=3023 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
Glimepiride
n=3010 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
Total
n=6033 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.9 Years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
64.2 Years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
64.0 Years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1185 Participants
n=5 Participants
|
1229 Participants
n=7 Participants
|
2414 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1838 Participants
n=5 Participants
|
1781 Participants
n=7 Participants
|
3619 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
519 Participants
n=5 Participants
|
513 Participants
n=7 Participants
|
1032 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2495 Participants
n=5 Participants
|
2487 Participants
n=7 Participants
|
4982 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
106 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
531 Participants
n=5 Participants
|
530 Participants
n=7 Participants
|
1061 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
155 Participants
n=5 Participants
|
169 Participants
n=7 Participants
|
324 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2217 Participants
n=5 Participants
|
2190 Participants
n=7 Participants
|
4407 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization until individual day of trial completion, up to 432 weeksPopulation: Treated set (TS): All patients treated with at least one dose of trial drug.
The first occurrence of any of the following Clinical Event Committee (CEC) confirmed adjudicated components of the primary composite endpoint: CV death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI (excluding silent MI), or nonfatal stroke is presented.
Outcome measures
| Measure |
Linagliptin
n=3023 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
Glimepiride
n=3010 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
|---|---|---|
|
The First 3-point Major Adverse Cardiovascular Events (3P-MACE)
|
20.7 Events/ 1000 patients-years
|
21.2 Events/ 1000 patients-years
|
SECONDARY outcome
Timeframe: From randomization until individual day of trial completion, up to 432 weeksPopulation: TS
The first key secondary endpoint was time to first occurrence of any of the following adjudicated components of the composite endpoint: CV death (including fatal stroke and fatal MI), non-fatal stroke, non-fatal MI (excluding silent MI), or hospitalisation for unstable angina pectoris.
Outcome measures
| Measure |
Linagliptin
n=3023 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
Glimepiride
n=3010 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
|---|---|---|
|
The First 4-point (4P)- MACE
|
23.4 Events/ 1000 patients-years
|
23.7 Events/ 1000 patients-years
|
SECONDARY outcome
Timeframe: From Visit 6 (Week 16) to Final visit (Week 432) (Maintenance Phase)Population: TS without duplicates (TS w/o duplicates), patients who are off-drug or died prior to regular study stop were handled as non-completers considered failure (NCF).
The second key secondary endpoint was a composite endpoint of treatment sustainability, defined as the percentage of patients taking trial medication at trial end, maintained glycaemic control (HbA1c ≤7.0%) without need for rescue medication, without \>2% weight gain, and without moderate/severe hypoglycaemic episodes during maintenance phase.
Outcome measures
| Measure |
Linagliptin
n=3014 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
Glimepiride
n=3000 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
|---|---|---|
|
Percentage of Participants Taking Trial Medication at Trial End, Maintained Glycaemic Control (HbA1c ≤7.0%) Without Need for Rescue Medication, Without >2% Weight Gain, and Without Moderate/Severe Hypoglycaemic Episodes During Maintenance Phase
|
16.0 Percentage of participants (%)
Interval 14.7 to 17.3
|
10.2 Percentage of participants (%)
Interval 9.1 to 11.3
|
SECONDARY outcome
Timeframe: From Visit 6 (Week 16) to Final visit (Week 432) (Maintenance Phase)Population: TS w/o duplicates (NCF)
The third key secondary endpoint was a composite endpoint of treatment sustainability, defined as percentage of patients who were on trial medication at trial end, maintained glycaemic control (HbA1c ≤7.0%) without need for rescue medication, and without \>2% weight gain during maintenance phase.
Outcome measures
| Measure |
Linagliptin
n=3014 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
Glimepiride
n=3000 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
|---|---|---|
|
Percentage of Participants Who Were on Trial Medication at Trial End, Maintained Glycaemic Control (HbA1c ≤7.0%) Without Need for Rescue Medication, and Without >2% Weight Gain During Maintenance Phase
|
17.4 Percentage of participants (%)
Interval 16.1 to 18.8
|
14.1 Percentage of participants (%)
Interval 12.9 to 15.4
|
SECONDARY outcome
Timeframe: From randomization until individual day of trial completion, up to 432 weeksPopulation: TS
Percentage of participants occurrence of at least one of the following adjudicated components of CV death (including fatal stroke and fatal MI), non-fatal MI (excluding silent MI) and non-fatal stroke is presented as secondary CV endpoint.
Outcome measures
| Measure |
Linagliptin
n=3023 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
Glimepiride
n=3010 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
|---|---|---|
|
Percentage of Participants With the Occurrence of at Least One Event of 3P-MACE
|
11.8 Percentage of participants (%)
Interval 10.7 to 13.0
|
12.0 Percentage of participants (%)
Interval 10.9 to 13.2
|
SECONDARY outcome
Timeframe: From randomization until individual day of trial completion, up to 432 weeksPopulation: TS
Percentage of participants occurrence of at least one of the following adjudicated components of CV death (including fatal stroke and fatal MI), non-fatal MI (excluding silent MI), non-fatal stroke, and hospitalisation for unstable angina pectoris is presented as secondary CV endpoint.
Outcome measures
| Measure |
Linagliptin
n=3023 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
Glimepiride
n=3010 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
|---|---|---|
|
Percentage of Participants With the Occurrence of at Least One Event of 4P -MACE
|
13.2 Percentage of participants (%)
Interval 12.0 to 14.4
|
13.3 Percentage of participants (%)
Interval 12.2 to 14.6
|
SECONDARY outcome
Timeframe: From start of the treatment until 7 days after the end of treatment, up to 433 weeksPopulation: TS
Percentage of participants with occurrence of any of the following components of the composite endpoint of all adjudication-confirmed events of: * CV death (including fatal stroke and fatal MI) * non-fatal MI * non-fatal stroke * hospitalisation for unstable angina pectoris * TIA * hospitalisation for heart failure * hospitalisation for coronary revascularisation procedures (CABG, PCI)
Outcome measures
| Measure |
Linagliptin
n=3023 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
Glimepiride
n=3010 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
|---|---|---|
|
Percentage of Participants With Occurrence of Any of the Components of the Composite Endpoint of All Adjudication-confirmed Events
|
17.1 Percentage of participants (%)
Interval 15.8 to 18.5
|
17.8 Percentage of participants (%)
Interval 16.4 to 19.2
|
SECONDARY outcome
Timeframe: From start of the treatment until 7 days after the end of treatment, up to 433 weeksPopulation: TS
Time to first occurrence of any of the following components of the composite endpoint of all adjudication-confirmed events of: * CV death (including fatal stroke and fatal MI) * non-fatal MI * non-fatal stroke * hospitalisation for unstable angina pectoris * Transient ischaemic attack (TIA) * hospitalisation for heart failure * hospitalisation for coronary revascularisation procedures (CABG, PCI)
Outcome measures
| Measure |
Linagliptin
n=3023 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
Glimepiride
n=3010 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
|---|---|---|
|
Time to First Occurrence of Any of the Components of the Composite Endpoint of All Adjudication-confirmed Events
|
31.1 Events/ 1000 patients-years
|
32.4 Events/ 1000 patients-years
|
SECONDARY outcome
Timeframe: Baseline and week 432Population: TS w/o duplicates considering all available data
Change from baseline to final visit in HbA1c is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment.
Outcome measures
| Measure |
Linagliptin
n=2951 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
Glimepiride
n=2949 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
|---|---|---|
|
Change From Baseline to Final Visit in Hemoglobin A1c (HbA1c)
|
0.06 Percentage glycosylated hemoglobin (%)
Standard Error 0.02
|
0.15 Percentage glycosylated hemoglobin (%)
Standard Error 0.02
|
SECONDARY outcome
Timeframe: Baseline and week 432Population: TS w/o duplicates considering all available data
Change from baseline to final visit in fasting plasma glucose (FPG) is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment.
Outcome measures
| Measure |
Linagliptin
n=2996 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
Glimepiride
n=2949 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
|---|---|---|
|
Change From Baseline to Final Visit in Fasting Plasma Glucose (FPG)
|
12.4 Milligram/ deciliter (mg/dL)
Standard Error 0.9
|
19.7 Milligram/ deciliter (mg/dL)
Standard Error 0.9
|
SECONDARY outcome
Timeframe: Baseline and week 432Population: TS w/o duplicates, participants on treatment
Change from baseline to final visit in total cholesterol, low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment.
Outcome measures
| Measure |
Linagliptin
n=3014 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
Glimepiride
n=3000 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
|---|---|---|
|
Change From Baseline to Final Visit Fasting Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol and High-density Lipoprotein (HDL) Cholesterol
LDL cholesterol
|
-6.1 mg/dL
Standard Error 0.6
|
-6.5 mg/dL
Standard Error 0.6
|
|
Change From Baseline to Final Visit Fasting Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol and High-density Lipoprotein (HDL) Cholesterol
HDL cholesterol
|
0.7 mg/dL
Standard Error 0.2
|
0.3 mg/dL
Standard Error 0.2
|
|
Change From Baseline to Final Visit Fasting Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol and High-density Lipoprotein (HDL) Cholesterol
Total cholesterol
|
-5.4 mg/dL
Standard Error 0.7
|
-0.5 mg/dL
Standard Error 0.7
|
SECONDARY outcome
Timeframe: Baseline and week 432Population: TS w/o duplicates, participants on treatment
Change from baseline to final visit in triglycerides is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment.
Outcome measures
| Measure |
Linagliptin
n=2788 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
Glimepiride
n=2762 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
|---|---|---|
|
Change From Baseline to Final Visit in Triglycerides
|
1.7 mg/dL
Standard Error 2.2
|
5.2 mg/dL
Standard Error 2.2
|
SECONDARY outcome
Timeframe: Baseline and week 432Population: TS w/o duplicates, participants on treatment
Change from baseline to final visit in creatinine is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment.
Outcome measures
| Measure |
Linagliptin
n=2917 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
Glimepiride
n=2898 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
|---|---|---|
|
Change From Baseline to Final Visit in Creatinine
|
0.08 mg/dL
Standard Error 0.01
|
0.09 mg/dL
Standard Error 0.01
|
SECONDARY outcome
Timeframe: Baseline and week 432Population: TS w/o duplicates, participants on treatment
Change from baseline to final visit in eGFR is presented as secondary diabetes-related endpoint. Least square mean is adjusted mean. The Final Visit value referred to the last value obtained on-treatment.
Outcome measures
| Measure |
Linagliptin
n=2917 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
Glimepiride
n=2898 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
|---|---|---|
|
Change From Baseline to Final Visit in Estimated Glomerular Filtration Rate (eGFR)
|
-4.0 mL/minute/1.73 meter^2
Standard Error 0.3
|
-5.0 mL/minute/1.73 meter^2
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline and week 432Population: TS w/o duplicates, participants on treatment
Change from baseline to final visit in UACR is presented as secondary diabetes-related endpoint. Least square mean is adjusted geometric mean (gMean) ratio. The Final Visit value referred to the last value obtained on-treatment.
Outcome measures
| Measure |
Linagliptin
n=2904 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
Glimepiride
n=2880 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
|---|---|---|
|
Change From Baseline to Final Visit in Urine Albumin Creatinine Ratio (UACR)
|
1.52 mg/ gcrea
Geometric Coefficient of Variation 1.83
|
1.57 mg/ gcrea
Geometric Coefficient of Variation 1.83
|
SECONDARY outcome
Timeframe: Baseline and week 432Population: TS w/o duplicates, participants on treatment
Percentage of patients with transition in albuminuria classes is presented as secondary endpoint. Data for last value on treatment (LVOT) to baseline (base) is presented.
Outcome measures
| Measure |
Linagliptin
n=3014 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
Glimepiride
n=3000 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
|---|---|---|
|
Percentage of Participants With Transition in Albuminuria Classes
Base (<30mg/gcrea) LVOT (<30mg/gcrea)
|
58.4 Percentage of participants (%)
|
57.7 Percentage of participants (%)
|
|
Percentage of Participants With Transition in Albuminuria Classes
Base(<30mg/gcrea)LVOT(>=30 to<=300mg/gcrea)
|
14.1 Percentage of participants (%)
|
16.0 Percentage of participants (%)
|
|
Percentage of Participants With Transition in Albuminuria Classes
Base (<30 mg/gcrea) LVOT (>300 mg/gcrea)
|
1.4 Percentage of participants (%)
|
1.4 Percentage of participants (%)
|
|
Percentage of Participants With Transition in Albuminuria Classes
Base (>=30 to <=300 mg/gcrea) LVOT(<30mg/gcrea)
|
5.4 Percentage of participants (%)
|
5.1 Percentage of participants (%)
|
|
Percentage of Participants With Transition in Albuminuria Classes
Base(>=30to<=300mg/gcrea)LVOT(>=30to<=300mg/gcrea)
|
12.7 Percentage of participants (%)
|
12.1 Percentage of participants (%)
|
|
Percentage of Participants With Transition in Albuminuria Classes
Base (>=30 to <=300 mg/gcrea) LVOT(>300 mg/gcrea)
|
3.5 Percentage of participants (%)
|
3.7 Percentage of participants (%)
|
|
Percentage of Participants With Transition in Albuminuria Classes
Base (>300 mg/gcrea) LVOT (<30 mg/gcrea)
|
0.1 Percentage of participants (%)
|
0.3 Percentage of participants (%)
|
|
Percentage of Participants With Transition in Albuminuria Classes
Base (>300 mg/gcrea) LVOT(>=30 to<=300mg/gcrea)
|
0.8 Percentage of participants (%)
|
0.9 Percentage of participants (%)
|
|
Percentage of Participants With Transition in Albuminuria Classes
Base (>300 mg/gcrea) LVOT(>300 mg/gcrea)
|
3.4 Percentage of participants (%)
|
2.7 Percentage of participants (%)
|
SECONDARY outcome
Timeframe: Baseline and week 208Population: Meal tolerance test(MTT) last observation carried forward(LOCF) set: Randomised and treated patients with one dose of study drug and signed the sub-study Informed Consent with valid baseline and on-treatment MTT. If values taken after rescue medication intake will be set to missing, last observed on-treatment value was carry forwarded.
The endpoint change from baseline of ISR at fixed glucose concentration at 208 weeks as derived from a 3-hour meal tolerance test is Beta-cell function sub-study endpoint.
Outcome measures
| Measure |
Linagliptin
n=40 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
Glimepiride
n=48 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
|---|---|---|
|
Change From Baseline of Insulin Secretion Rate (ISR) at Fixed Glucose Concentration at 208 Weeks
|
11.07 Picomol/ minute/meter^2 (pmol/min/m²)
Standard Error 15.07
|
6.95 Picomol/ minute/meter^2 (pmol/min/m²)
Standard Error 13.76
|
SECONDARY outcome
Timeframe: 433 weeksPopulation: Full analysis set cognition(FAS-COG): Randomised and treated patients with one dose of study drug, baseline assessment (the z-scores, A\&E or Mini-mental state examination(MMSE) can be calculated), years of formal education with baseline MMSE≥24 and at least one on-treatment assessment (of which at least one of the RBI scores can be calculated).
Occurrence of accelerated cognitive decline based on regression based index (RBI) score at end of follow-up (a dichotomous outcome measure; presence or absence of accelerated cognitive decline) is Cognition sub-study endpoint.
Outcome measures
| Measure |
Linagliptin
n=1618 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
Glimepiride
n=1545 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
|---|---|---|
|
Percentage of Participants With Occurrence of Accelerated Cognitive Decline at End of Follow-up
|
27.8 Percentage of participants (%)
Interval 25.6 to 30.0
|
27.6 Percentage of participants (%)
Interval 25.4 to 29.9
|
SECONDARY outcome
Timeframe: BaselinePopulation: The sub-study was stopped early and required target with an estimated time point of 432 weeks was not achieved for this endpoint. Thus the data were not unblinded and only the baseline data collected were reported overall and not by treatment arm for this endpoint.
Baseline data for the continuous glucose monitoring sub-study was collected and analyzed. However, the participant number was far less than original planned. The study was stopped early around week 64 (V9) due to recruitment issues and data were not pre-specified to be analyzed and reported at week 64 time point as target was with an estimated time point of 432 weeks for primary or secondary end points. Thus this endpoint was not analysed and only the baseline data collected were analysed and the results are reported in this CGM substudy endpoint.
Outcome measures
| Measure |
Linagliptin
n=44 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
Glimepiride
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
|---|---|---|
|
Continuous Glucose Monitoring (CGM) Sub-study: Change From Baseline in the Inter-quartile Range of Diurnal Glucose Variability (Milligrams/ Deciliter) to End of Study
|
44.2 Milligrams/ deciliter (mg/ dL)
Standard Deviation 12.6
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: The sub-study was stopped early and required target with an estimated time point of 432 weeks was not achieved for this endpoint. Thus the data were not unblinded and only the baseline data collected were reported overall and not by treatment arm for this endpoint.
Baseline data for the continuous glucose monitoring sub-study was collected and analyzed. However, the participant number was far less than original planned. The study was stopped early around week 64 (V9) due to recruitment issues and data were not pre-specified to be analyzed and reported at week 64 time point as target was with an estimated time point of 432 weeks for primary or secondary end points. Thus this endpoint was not analysed and only the baseline data collected were analysed and the results are reported in this CGM substudy endpoint.
Outcome measures
| Measure |
Linagliptin
n=44 Participants
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
Glimepiride
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
|---|---|---|
|
CGM Sub-study : Change From Baseline in the Inter-quartile Range of Diurnal Glucose Variability (Millimoles/ Litre) to End of Study
|
2.45 Millimoles/ Litre (mmol/L)
Standard Deviation 0.7
|
—
|
Adverse Events
Linagliptin
Serious events: 1403 serious events
Other events: 2376 other events
Deaths: 308 deaths
Glimepiride
Serious events: 1448 serious events
Other events: 2504 other events
Deaths: 336 deaths
Serious adverse events
| Measure |
Linagliptin
n=3023 participants at risk
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
Glimepiride
n=3010 participants at risk
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
|---|---|---|
|
Gastrointestinal disorders
Haemorrhoids
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Product Issues
Device battery issue
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Product Issues
Device defective
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Product Issues
Device dislocation
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Product Issues
Device failure
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Product Issues
Device fastener issue
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Product Issues
Device leakage
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Product Issues
Device loosening
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Product Issues
Device malfunction
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Product Issues
Device occlusion
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Psychiatric disorders
Acute psychosis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Psychiatric disorders
Agitated depression
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Psychiatric disorders
Agitation
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Psychiatric disorders
Anxiety
|
0.13%
4/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Psychiatric disorders
Burnout syndrome
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Psychiatric disorders
Confusional state
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Psychiatric disorders
Delirium
|
0.20%
6/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Psychiatric disorders
Delirium tremens
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Psychiatric disorders
Depression
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.20%
6/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Psychiatric disorders
Depression suicidal
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Psychiatric disorders
Disorientation
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Psychiatric disorders
Encopresis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Ileus
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.60%
18/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.47%
14/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Intestinal haematoma
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Intestinal mass
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Jejunal perforation
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.20%
6/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.30%
9/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Lumbar hernia
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Malignant bowel obstruction
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Melaena
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Mesenteric artery thrombosis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Nausea
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.17%
5/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Oesophageal fistula
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.46%
14/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.60%
18/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.20%
6/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Blood and lymphatic system disorders
Haemorrhagic diathesis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.17%
5/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Blood and lymphatic system disorders
Splenic haematoma
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Blood and lymphatic system disorders
Splenic vein thrombosis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.60%
18/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.40%
12/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.7%
52/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
1.9%
56/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Adams-Stokes syndrome
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Angina pectoris
|
1.2%
37/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
1.3%
40/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Angina unstable
|
1.8%
54/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
2.2%
65/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Aortic valve disease
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.17%
5/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Arrhythmia
|
0.13%
4/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.17%
5/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.13%
4/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Atrial fibrillation
|
1.3%
39/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
1.6%
48/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Atrial flutter
|
0.76%
23/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.47%
14/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Atrial tachycardia
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Atrioventricular block
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.33%
10/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.27%
8/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Bradyarrhythmia
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Bradycardia
|
0.20%
6/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.23%
7/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Bundle branch block
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Bundle branch block left
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Cardiac aneurysm
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Cardiac arrest
|
0.13%
4/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.27%
8/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Cardiac asthma
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Cardiac disorder
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Cardiac failure
|
1.9%
58/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
1.8%
53/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Cardiac failure acute
|
0.23%
7/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.20%
6/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.30%
9/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.40%
12/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.2%
37/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
1.5%
45/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Cardiac perforation
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Cardiac valve disease
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.13%
4/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Cardiogenic shock
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Cardiomyopathy
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Cor pulmonale
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Coronary artery disease
|
1.4%
43/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
1.4%
42/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Coronary artery dissection
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.13%
4/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.40%
12/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Diastolic dysfunction
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Heart valve incompetence
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.13%
4/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Left ventricular failure
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Long QT syndrome
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Mitral valve stenosis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Myocardial infarction
|
1.6%
49/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
2.1%
64/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.46%
14/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.30%
9/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Myocardial rupture
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Palpitations
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Pericardial effusion
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Pericarditis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Postinfarction angina
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Prinzmetal angina
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Pulmonary valve stenosis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Right ventricular dysfunction
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Right ventricular failure
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Silent myocardial infarction
|
0.17%
5/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.17%
5/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Sinoatrial block
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Sinus arrest
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Sinus arrhythmia
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Sinus bradycardia
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.13%
4/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.17%
5/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Sinus tachycardia
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Supraventricular tachyarrhythmia
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.23%
7/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Tachycardia
|
0.17%
5/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Tachycardia paroxysmal
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Thyrotoxic cardiomyopathy
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Trifascicular block
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.13%
4/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Ventricular hypokinesia
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.13%
4/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Cardiac disorders
Wolff-Parkinson-White syndrome
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Congenital, familial and genetic disorders
Adenomatous polyposis coli
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Congenital, familial and genetic disorders
Arteriovenous malformation
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Congenital, familial and genetic disorders
Choledochal cyst
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Congenital, familial and genetic disorders
Congenital cystic kidney disease
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Congenital, familial and genetic disorders
Corneal dystrophy
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Congenital, familial and genetic disorders
Developmental hip dysplasia
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Congenital, familial and genetic disorders
Exomphalos
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Congenital, familial and genetic disorders
Fibrous dysplasia of bone
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Congenital, familial and genetic disorders
Hereditary haemochromatosis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Congenital, familial and genetic disorders
Ichthyosis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Congenital, familial and genetic disorders
Left ventricle outflow tract obstruction
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.20%
6/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Congenital, familial and genetic disorders
Porokeratosis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Congenital, familial and genetic disorders
Stargardt's disease
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Congenital, familial and genetic disorders
Urachal abnormality
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Ear and labyrinth disorders
Acute vestibular syndrome
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Ear and labyrinth disorders
Aural polyp
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Ear and labyrinth disorders
Conductive deafness
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Ear and labyrinth disorders
Deafness
|
0.23%
7/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.20%
6/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Ear and labyrinth disorders
Ear canal stenosis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Ear and labyrinth disorders
Inner ear disorder
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Ear and labyrinth disorders
Mixed deafness
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Ear and labyrinth disorders
Vertigo
|
0.30%
9/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.40%
12/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Endocrine disorders
Basedow's disease
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Endocrine disorders
Goitre
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Endocrine disorders
Hypoparathyroidism
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Endocrine disorders
Thyroid mass
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Age-related macular degeneration
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Amaurosis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Amaurosis fugax
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Angle closure glaucoma
|
0.13%
4/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Aphakia
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Blepharitis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Blindness
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Blindness transient
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Blindness unilateral
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Cataract
|
0.53%
16/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.70%
21/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Chalazion
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Detachment of retinal pigment epithelium
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Diabetic retinopathy
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Diplopia
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Dry age-related macular degeneration
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Endocrine ophthalmopathy
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Eye haemorrhage
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Eye swelling
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Eyelid ptosis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Eyelid rash
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Glaucoma
|
0.96%
29/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
1.0%
31/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Iris neovascularisation
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Keratitis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Lens dislocation
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Macular degeneration
|
0.40%
12/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.37%
11/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Macular fibrosis
|
0.17%
5/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.20%
6/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Macular hole
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Neovascular age-related macular degeneration
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Open angle glaucoma
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Panophthalmitis
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Pterygium
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Retinal artery embolism
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Retinal artery occlusion
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Retinal degeneration
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Retinal detachment
|
0.20%
6/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.23%
7/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Retinal tear
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Retinal vein occlusion
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Retinopathy
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Ulcerative keratitis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Uveitic glaucoma
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Vision blurred
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Visual impairment
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Vitreous adhesions
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Vitreous degeneration
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Vitreous haemorrhage
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Abdominal incarcerated hernia
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.23%
7/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.23%
7/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Acute abdomen
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Anal fistula
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Appendiceal mucocoele
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Ascites
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Bezoar
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Colitis
|
0.20%
6/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Colon dysplasia
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Constipation
|
0.13%
4/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Dental necrosis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.17%
5/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.17%
5/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Diverticulum
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Duodenal polyp
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Enteritis
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Erosive duodenitis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Food poisoning
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.13%
4/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Gastritis
|
0.17%
5/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.20%
6/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Gastroduodenal haemorrhage
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.53%
16/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.33%
10/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Haematemesis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Haematochezia
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Pancreatic failure
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Pancreatic mass
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.33%
10/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.37%
11/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.26%
8/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.27%
8/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.17%
5/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Pancreatitis necrotising
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Peptic ulcer perforation
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Rectal polyp
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Retroperitoneal fibrosis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Salivary gland calculus
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Salivary gland mass
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.17%
5/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Subileus
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Tongue oedema
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.13%
4/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.23%
7/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
General disorders
Adhesion
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
General disorders
Adverse drug reaction
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
General disorders
Asthenia
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.23%
7/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
General disorders
Cardiac death
|
0.23%
7/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
General disorders
Chest discomfort
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.20%
6/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
General disorders
Chest pain
|
1.7%
50/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
1.7%
52/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
General disorders
Chills
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
General disorders
Condition aggravated
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
General disorders
Death
|
0.66%
20/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.66%
20/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
General disorders
Discomfort
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
General disorders
Exercise tolerance decreased
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
General disorders
Fatigue
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
General disorders
Fibrosis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
General disorders
General physical health deterioration
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
General disorders
Hernia
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
General disorders
Hyperthermia
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
General disorders
Impaired healing
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
General disorders
Implant site extravasation
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
General disorders
Implant site haematoma
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
General disorders
Malaise
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
General disorders
Mass
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
General disorders
Multi-organ disorder
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.23%
7/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
General disorders
Non-cardiac chest pain
|
0.26%
8/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.27%
8/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
General disorders
Oedema peripheral
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
General disorders
Puncture site haemorrhage
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
General disorders
Pyrexia
|
0.23%
7/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.27%
8/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
General disorders
Retention cyst
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
General disorders
Sudden cardiac death
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
General disorders
Sudden death
|
0.30%
9/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
General disorders
Swelling
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
General disorders
Vascular stent stenosis
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.20%
6/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Hepatobiliary disorders
Biliary colic
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Hepatobiliary disorders
Cholangitis
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.66%
20/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.53%
16/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.30%
9/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.17%
5/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.66%
20/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.47%
14/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Hepatobiliary disorders
Cholestatic liver injury
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Hepatobiliary disorders
Cirrhosis alcoholic
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Hepatobiliary disorders
Gallbladder necrosis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.20%
6/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Hepatobiliary disorders
Hepatic fibrosis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Hepatobiliary disorders
Hepatic mass
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.20%
6/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.17%
5/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Hepatobiliary disorders
Hydrocholecystis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Hepatobiliary disorders
Jaundice
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Hepatobiliary disorders
Liver disorder
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Immune system disorders
Allergy to vaccine
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Immune system disorders
Anaphylactic reaction
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Immune system disorders
Hypersensitivity
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Abdominal abscess
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Abscess
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Abscess intestinal
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Abscess jaw
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Abscess limb
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Abscess neck
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Actinomycotic pulmonary infection
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Acute hepatitis C
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Administration site cellulitis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Anal abscess
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Appendiceal abscess
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Appendicitis
|
0.17%
5/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.17%
5/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Appendicitis perforated
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Arthritis bacterial
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Arthritis infective
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Atypical pneumonia
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Bacteraemia
|
0.13%
4/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Bacterial sepsis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Biliary sepsis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Body tinea
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Bronchitis
|
0.50%
15/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.37%
11/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Candida sepsis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Cellulitis
|
0.56%
17/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.60%
18/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Cholecystitis infective
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Chronic tonsillitis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Clostridium difficile infection
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Colon gangrene
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Creutzfeldt-Jakob disease
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Cystitis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Cystitis escherichia
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Device related infection
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Diabetic foot infection
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Diabetic gangrene
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Diarrhoea infectious
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Diverticulitis
|
0.20%
6/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.20%
6/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Empyema
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Encephalitis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Endocarditis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Endocarditis bacterial
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Enteritis infectious
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Epididymitis
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Epiglottitis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Erysipelas
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.37%
11/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Escherichia sepsis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
External ear cellulitis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Febrile infection
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Fungal infection
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Gallbladder abscess
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Gangrene
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Gastric ulcer helicobacter
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Gastroenteritis
|
0.56%
17/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.56%
17/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Gastroenteritis clostridial
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Gastroenteritis viral
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Gastrointestinal infection
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Gingival abscess
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Graft infection
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Groin abscess
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Haematoma infection
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Haemophilus infection
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Helicobacter gastritis
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Hepatitis A
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Hepatitis C
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Herpes simplex
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Herpes zoster
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.30%
9/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Infected bite
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Infected dermal cyst
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Infected skin ulcer
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Infection
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Infectious colitis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Infective spondylitis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Influenza
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.27%
8/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Kidney infection
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Liver abscess
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Localised infection
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.13%
4/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Lung infection
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Mediastinitis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Medical device site infection
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Meningitis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Meningitis bacterial
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Meningitis viral
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Meningoencephalitis viral
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Morganella infection
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Nosocomial infection
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Orchitis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Osteomyelitis
|
0.26%
8/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Osteomyelitis chronic
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Osteomyelitis fungal
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Otitis media
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Parotitis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Pelvic abscess
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Perichondritis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Periodontitis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Peritonitis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Pneumonia
|
2.7%
83/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
2.8%
83/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Pneumonia bacterial
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Pneumonia necrotising
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Post procedural cellulitis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Post procedural infection
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Postoperative abscess
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Postoperative wound infection
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Purulence
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Pyelitis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Pyelonephritis
|
0.26%
8/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Pyelonephritis acute
|
0.13%
4/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Pyelonephritis fungal
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Pyonephrosis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Respiratory tract infection
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.23%
7/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Retroperitoneal abscess
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Rotavirus infection
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Scrotal abscess
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Scrub typhus
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Sepsis
|
0.56%
17/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.80%
24/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Septic arthritis streptococcal
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Septic shock
|
0.20%
6/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.23%
7/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Sialoadenitis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Sinusitis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Small intestine gangrene
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Soft tissue infection
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Staphylococcal infection
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Tooth abscess
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Tracheobronchitis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Tuberculosis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.17%
5/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Ureteritis
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Urethritis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Urinary tract infection
|
0.99%
30/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
1.0%
31/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Urinary tract infection fungal
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Urosepsis
|
0.23%
7/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.20%
6/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Varicella
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Vestibular neuronitis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Viral infection
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Vulval abscess
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Wound infection
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Accident
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Anaesthetic complication cardiac
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Anastomotic leak
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.20%
6/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.37%
11/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Arterial restenosis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Bladder injury
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Bone fragmentation
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Brain herniation
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Cardiac valve replacement complication
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Carotid artery restenosis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Chemical burn
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Conjunctival laceration
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.13%
4/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.17%
5/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Coronary artery reocclusion
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.17%
5/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Crush injury
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Fall
|
1.0%
31/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
1.5%
44/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.13%
4/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.30%
9/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.20%
6/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Fracture displacement
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Fracture of penis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Graft thrombosis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.17%
5/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.23%
7/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.53%
16/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.20%
6/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Ilium fracture
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Impacted fracture
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Incarcerated incisional hernia
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Inflammation of wound
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Injury corneal
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.20%
6/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.20%
6/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.17%
5/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.23%
7/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.17%
5/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.20%
6/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.13%
4/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Pneumoconiosis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Post procedural fistula
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Post procedural inflammation
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Post procedural urine leak
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Postoperative renal failure
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Postpericardiotomy syndrome
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Pulmonary contusion
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.20%
6/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.17%
5/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.43%
13/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.23%
7/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Scar
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.26%
8/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Spinal cord injury cervical
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Splenic injury
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.17%
5/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.17%
5/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.17%
5/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.23%
7/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.17%
5/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.20%
6/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Transplant dysfunction
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Traumatic arthritis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Urethral injury
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Wound
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Wound necrosis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
Alanine aminotransferase increased
|
0.20%
6/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.23%
7/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
Amylase increased
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
Anticoagulation drug level below therapeutic
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
Arteriogram coronary
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
Aspartate aminotransferase increased
|
0.20%
6/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.23%
7/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
Blood creatine phosphokinase MB increased
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
Blood creatinine increased
|
0.40%
12/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.37%
11/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
Blood pressure decreased
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
Blood pressure increased
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
Body temperature increased
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
Cardiac stress test abnormal
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
Computerised tomogram head abnormal
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
Electrocardiogram ST segment depression
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
Electrocardiogram T wave inversion
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
Electrocardiogram abnormal
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
Electrocardiogram ambulatory abnormal
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
Full blood count decreased
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.23%
7/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.23%
7/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
Heart rate decreased
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
Hepatic enzyme increased
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
Hepatitis C virus test
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
International normalised ratio decreased
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
International normalised ratio increased
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
Lipase increased
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
Liver function test increased
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
Myelocyte count increased
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
Positron emission tomogram abnormal
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
Prostatic specific antigen increased
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
Transaminases increased
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
Troponin increased
|
0.13%
4/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
Urine albumin/creatinine ratio increased
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
Weight decreased
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
Weight increased
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
White blood cell count increased
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.43%
13/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.33%
10/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Metabolism and nutrition disorders
Gout
|
0.13%
4/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.20%
6/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.27%
8/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.23%
7/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.96%
29/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.13%
4/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.20%
6/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.13%
4/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Metabolism and nutrition disorders
Metabolic disorder
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.17%
5/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.20%
6/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.30%
9/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.20%
6/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.13%
4/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.20%
6/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.27%
8/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Bone atrophy
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Facet joint syndrome
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.13%
4/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.26%
8/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.40%
12/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Limb deformity
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.36%
11/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.23%
7/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.13%
4/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.6%
49/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
2.1%
63/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.30%
9/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.43%
13/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.13%
4/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.23%
7/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.17%
5/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.13%
4/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.40%
12/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Spinal disorder
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Spinal ligament ossification
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.17%
5/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.27%
8/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute promyelocytic leukaemia
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of appendix
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.26%
8/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.23%
7/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal neoplasm
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiosarcoma
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.3%
39/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
1.1%
33/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basosquamous carcinoma of skin
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.13%
4/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.27%
8/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder papilloma
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.27%
8/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma recurrent
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.17%
5/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.17%
5/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm benign
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.40%
12/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.30%
9/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage IV
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast neoplasm
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour pulmonary
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma in situ of skin
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system lymphoma
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.40%
12/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.17%
5/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conjunctival melanoma
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cutaneous lymphoma
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dysplastic naevus
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Enchondromatosis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ependymoma benign
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Essential thrombocythaemia
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibrous histiocytoma
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder adenocarcinoma
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric adenoma
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.20%
6/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal melanoma
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrooesophageal cancer
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hairy cell leukaemia
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypopharyngeal neoplasm
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal adenocarcinoma
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal papillary mucinous neoplasm
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal squamous cell carcinoma
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyoma
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna recurrent
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.13%
4/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.27%
8/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage I
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage II
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage IV
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage III
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.33%
10/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.20%
6/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma metastatic
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage III
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphocytic leukaemia
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.23%
7/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of unknown primary site
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant polyp
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma benign
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bladder
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.17%
5/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.17%
5/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mucinous adenocarcinoma of appendix
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mycosis fungoides
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myxofibrosarcoma
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasopharyngeal cancer
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm prostate
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neurofibroma
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage IV
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal squamous cell carcinoma
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral papilloma
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal cancer
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian epithelial cancer
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.30%
9/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.30%
9/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma stage IV
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paranasal sinus and nasal cavity malignant neoplasm
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.20%
6/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleural sarcoma
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Porocarcinoma
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prolactin-producing pituitary tumour
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.93%
28/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.96%
29/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage 0
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenoma
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.17%
5/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer metastatic
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Refractory anaemia with ringed sideroblasts
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.20%
6/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.20%
6/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland neoplasm
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sebaceous carcinoma
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin angiosarcoma
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine adenocarcinoma
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Soft tissue sarcoma
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.20%
6/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.20%
6/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.20%
6/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.43%
13/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.53%
16/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the cervix
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the hypopharynx
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the oral cavity
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the vulva
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thymoma
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell cancer of the renal pelvis and ureter
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour ulceration
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vipoma
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Waldenstrom's macroglobulinaemia
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Aphasia
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Basal ganglia haematoma
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Basal ganglia haemorrhage
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Basal ganglia infarction
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Basilar artery stenosis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Basilar artery thrombosis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Brain stem stroke
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Carotid artery aneurysm
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.17%
5/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.43%
13/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.33%
10/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Central pain syndrome
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Cerebellar infarction
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Cerebral infarction
|
0.46%
14/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.43%
13/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Cerebral small vessel ischaemic disease
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.7%
51/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
2.0%
61/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Coma
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Dementia
|
0.43%
13/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.63%
19/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Dizziness
|
0.36%
11/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.23%
7/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Drop attacks
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Dysarthria
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Encephalomalacia
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Epilepsy
|
0.13%
4/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.37%
11/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Generalised non-convulsive epilepsy
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Haemorrhagic cerebral infarction
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.20%
6/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Headache
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Hemianopia
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Hemianopia homonymous
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Hemiparesis
|
0.20%
6/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Hemiplegia
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Hydrocephalus
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Hypertensive cerebrovascular disease
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
IIIrd nerve paralysis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Internal carotid artery kinking
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Intracranial haematoma
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Intracranial mass
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Ischaemic stroke
|
0.73%
22/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.66%
20/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Lacunar infarction
|
0.13%
4/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Lacunar stroke
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Loss of consciousness
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Memory impairment
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Mental impairment
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Mononeuritis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Monoparesis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Myelopathy
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Neurological symptom
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Paralysis recurrent laryngeal nerve
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Parkinson's disease
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Parkinsonism
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Partial seizures
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Polyneuropathy
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Presyncope
|
0.17%
5/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.17%
5/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Quadriplegia
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Radicular syndrome
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Retinal migraine
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Sciatica
|
0.23%
7/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.23%
7/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Seizure
|
0.20%
6/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.20%
6/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Spinal claudication
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Spinal cord compression
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Spinal cord disorder
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Spondylitic myelopathy
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Subdural hygroma
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Syncope
|
0.56%
17/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.60%
18/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Tension headache
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Thrombotic cerebral infarction
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.0%
31/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
1.1%
33/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Tunnel vision
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Vascular dementia
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Vascular encephalopathy
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Vertebral artery aneurysm
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Vertebral artery stenosis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Psychiatric disorders
Major depression
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.17%
5/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Psychiatric disorders
Mental disorder
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Psychiatric disorders
Mental status changes
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.17%
5/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Psychiatric disorders
Panic disorder
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Psychiatric disorders
Schizophrenia
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Psychiatric disorders
Somatic symptom disorder
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Psychiatric disorders
Substance abuse
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Psychiatric disorders
Suicidal ideation
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Psychiatric disorders
Suicide attempt
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Psychiatric disorders
Transient psychosis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.6%
47/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
1.4%
41/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Atonic urinary bladder
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Bladder neck obstruction
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Bladder outlet obstruction
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Bladder perforation
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Bladder prolapse
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Calculus bladder
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Calculus urinary
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.50%
15/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.20%
6/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Dysuria
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
End stage renal disease
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Glomerulonephritis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Glomerulonephritis membranous
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Haematuria
|
0.23%
7/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.23%
7/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.20%
6/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Leukocyturia
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Lower urinary tract symptoms
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.46%
14/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Obstructive nephropathy
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Prerenal failure
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Proteinuria
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Renal artery arteriosclerosis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Renal colic
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Renal failure
|
0.66%
20/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.43%
13/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Renal impairment
|
0.26%
8/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.33%
10/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Renal mass
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Stag horn calculus
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Ureteral disorder
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Ureteral polyp
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.17%
5/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.27%
8/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Urethral meatus stenosis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Urinary retention
|
0.43%
13/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Reproductive system and breast disorders
Acquired phimosis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.17%
5/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.63%
19/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Reproductive system and breast disorders
Cystocele
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Reproductive system and breast disorders
Ovarian disorder
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Reproductive system and breast disorders
Pelvic prolapse
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Reproductive system and breast disorders
Prostatic disorder
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Reproductive system and breast disorders
Prostatism
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Reproductive system and breast disorders
Rectocele
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.13%
4/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Reproductive system and breast disorders
Vulvar dysplasia
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.30%
9/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.26%
8/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.33%
10/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.17%
5/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.23%
7/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.76%
23/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.86%
26/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragm muscle weakness
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic paralysis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.50%
15/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.73%
22/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.17%
5/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.23%
7/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal disorder
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pickwickian syndrome
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.26%
8/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.17%
5/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.17%
5/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.20%
6/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.53%
16/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.20%
6/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.37%
11/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.17%
5/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.23%
7/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary toxicity
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.26%
8/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.47%
14/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.17%
5/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheomalacia
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord polyp
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.13%
4/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Skin and subcutaneous tissue disorders
Diabetic neuropathic ulcer
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Skin and subcutaneous tissue disorders
Diabetic ulcer
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Skin and subcutaneous tissue disorders
Macule
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Skin and subcutaneous tissue disorders
Nail bed inflammation
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin plaque
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.20%
6/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Skin and subcutaneous tissue disorders
Solar lentigo
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Skin and subcutaneous tissue disorders
Transient acantholytic dermatosis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Skin and subcutaneous tissue disorders
Umbilical haematoma
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Social circumstances
Loss of personal independence in daily activities
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Social circumstances
Sexual abuse
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Surgical and medical procedures
Cardiac operation
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Surgical and medical procedures
Cardiac pacemaker replacement
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Surgical and medical procedures
Colostomy
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Surgical and medical procedures
Colostomy closure
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Surgical and medical procedures
Implantable defibrillator insertion
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Surgical and medical procedures
Mitral valve replacement
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Surgical and medical procedures
Prostatic operation
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Surgical and medical procedures
Shoulder arthroplasty
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Surgical and medical procedures
Spinal decompression
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Surgical and medical procedures
Stent placement
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Surgical and medical procedures
Thyroidectomy
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Surgical and medical procedures
Transurethral prostatectomy
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Accelerated hypertension
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Aneurysm
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Aortic aneurysm
|
0.17%
5/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.23%
7/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Aortic dissection
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Aortic occlusion
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Aortic stenosis
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Arterial occlusive disease
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Arteritis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Atherosclerotic plaque rupture
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Circulatory collapse
|
0.13%
4/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.20%
6/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Deep vein thrombosis
|
0.30%
9/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.56%
17/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Diabetic vascular disorder
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Embolism
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Embolism venous
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Extremity necrosis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Femoral artery aneurysm
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Femoral artery embolism
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Haematoma
|
0.13%
4/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Haemodynamic instability
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Haemorrhage
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Hypertension
|
0.40%
12/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.30%
9/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Hypertensive crisis
|
0.50%
15/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.70%
21/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Hypertensive emergency
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Hypotension
|
0.17%
5/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.10%
3/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Hypovolaemic shock
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Infarction
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Intermittent claudication
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Ischaemia
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Ischaemic limb pain
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Lymphocele
|
0.07%
2/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Orthostatic hypotension
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.20%
6/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.40%
12/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.33%
10/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.00%
0/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.17%
5/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.13%
4/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Shock
|
0.10%
3/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Thrombophlebitis
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Varicose vein
|
0.03%
1/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.07%
2/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
0.03%
1/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
Other adverse events
| Measure |
Linagliptin
n=3023 participants at risk
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of 5 milligram (mg) linagliptin plus 1 over-encapsulated tablet of placebo matching glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
Glimepiride
n=3010 participants at risk
After 2-4 weeks placebo run-in phase, participants were administered 1 tablet of placebo matching linagliptin plus 1 over-encapsulated tablet of 1 to 4 mg glimepiride, which was uptitrated in 4-week intervals during the first 16 weeks of treatment to the next dose. Both doses were administered once daily orally up to an estimated 432 weeks treatment period.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.9%
208/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
5.9%
178/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Eye disorders
Cataract
|
7.2%
219/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
6.7%
203/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Constipation
|
6.5%
195/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
5.7%
173/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.1%
365/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
10.8%
324/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Gastrointestinal disorders
Nausea
|
5.2%
157/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
5.4%
164/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
General disorders
Fatigue
|
3.9%
118/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
5.4%
162/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
General disorders
Oedema peripheral
|
5.0%
150/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
6.4%
194/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Bronchitis
|
10.4%
315/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
11.3%
340/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Influenza
|
8.9%
268/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
8.1%
243/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
17.5%
530/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
17.2%
517/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.4%
313/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
10.6%
319/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Infections and infestations
Urinary tract infection
|
10.5%
318/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
10.4%
312/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Injury, poisoning and procedural complications
Fall
|
5.0%
151/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
5.6%
170/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Investigations
Lipase increased
|
6.9%
209/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
5.1%
154/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
14.0%
422/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
16.0%
483/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
9.9%
299/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
35.4%
1067/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.3%
310/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
10.2%
308/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.8%
388/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
12.2%
368/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.0%
150/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
6.0%
181/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
7.4%
224/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
8.7%
261/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
215/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
7.4%
224/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Dizziness
|
9.4%
283/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
11.9%
358/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Nervous system disorders
Headache
|
8.9%
268/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
9.8%
295/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.4%
284/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
9.6%
290/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
|
Vascular disorders
Hypertension
|
14.2%
430/3023 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
15.0%
452/3010 • From start of the treatment until 7 days after the end of treatment, up to 433 weeks.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER