Trial Outcomes & Findings for A Study to Assess All-Cause Mortality and Cardiovascular Morbidity in Participants With Chronic Kidney Disease (CKD) on Dialysis and Those Not on Renal Replacement Therapy Receiving Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) or Reference Erythropoietin Stimulating Agents (ESAs) (NCT NCT00773513)
NCT ID: NCT00773513
Last Updated: 2019-08-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
2825 participants
Primary outcome timeframe
Baseline up to approximately 8.5 years
Results posted on
2019-08-20
Participant Flow
Participant milestones
| Measure |
Erythropoiesis Stimulating Agents (ESA)
Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta.
|
Methoxy Polyethylene Glycol-Epoetin Beta
Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin \[Hb\] 10-12 grams per deciliter \[g/dL\]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.
|
|---|---|---|
|
Overall Study
STARTED
|
1413
|
1412
|
|
Overall Study
Received Study Treatment
|
1409
|
1409
|
|
Overall Study
COMPLETED
|
312
|
303
|
|
Overall Study
NOT COMPLETED
|
1101
|
1109
|
Reasons for withdrawal
| Measure |
Erythropoiesis Stimulating Agents (ESA)
Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta.
|
Methoxy Polyethylene Glycol-Epoetin Beta
Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin \[Hb\] 10-12 grams per deciliter \[g/dL\]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.
|
|---|---|---|
|
Overall Study
Renal Transplant
|
254
|
263
|
|
Overall Study
Adverse Event / Intercurrent Illness
|
40
|
48
|
|
Overall Study
Withdrew Consent
|
68
|
69
|
|
Overall Study
Refused Treatment / Did not Cooperate
|
26
|
32
|
|
Overall Study
Failure to Return
|
22
|
8
|
|
Overall Study
Insufficient Therapeutic Response
|
1
|
18
|
|
Overall Study
Reason Not Specified
|
159
|
126
|
|
Overall Study
Death
|
531
|
545
|
Baseline Characteristics
A Study to Assess All-Cause Mortality and Cardiovascular Morbidity in Participants With Chronic Kidney Disease (CKD) on Dialysis and Those Not on Renal Replacement Therapy Receiving Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) or Reference Erythropoietin Stimulating Agents (ESAs)
Baseline characteristics by cohort
| Measure |
Erythropoiesis Stimulating Agents
n=1413 Participants
Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta.
|
Methoxy Polyethylene Glycol-Epoetin Beta
n=1412 Participants
Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin \[Hb\] 10-12 grams per deciliter \[g/dL\]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.
|
Total
n=2825 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.6 years
STANDARD_DEVIATION 14.8 • n=99 Participants
|
62.2 years
STANDARD_DEVIATION 15.0 • n=107 Participants
|
62.4 years
STANDARD_DEVIATION 14.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
581 Participants
n=99 Participants
|
605 Participants
n=107 Participants
|
1186 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
832 Participants
n=99 Participants
|
807 Participants
n=107 Participants
|
1639 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
1221 Participants
n=99 Participants
|
1218 Participants
n=107 Participants
|
2439 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
111 Participants
n=99 Participants
|
119 Participants
n=107 Participants
|
230 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
40 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
41 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline up to approximately 8.5 yearsPopulation: The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment. Data are reported for participants with an event.
Outcome measures
| Measure |
Erythropoiesis Stimulating Agents
n=1409 Participants
Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta.
|
Methoxy Polyethylene Glycol-Epoetin Beta
n=1409 Participants
Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin \[Hb\] 10-12 grams per deciliter \[g/dL\]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.
|
|---|---|---|
|
Time to Composite of All-Cause Mortality and Non-Fatal Cardiovascular Events (Myocardial Infarction, Stroke) Defined as Time Between First Dose of Study Medication and Date of Death or Non-Fatal Cardiovascular Events, Whichever Occurred First
|
5.1 years
Interval 4.8 to 5.6
|
5.1 years
Interval 4.7 to 5.4
|
SECONDARY outcome
Timeframe: Baseline up to approximately 8.5 yearsPopulation: The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment. Data are reported for participants with an event.
Outcome measures
| Measure |
Erythropoiesis Stimulating Agents
n=1409 Participants
Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta.
|
Methoxy Polyethylene Glycol-Epoetin Beta
n=1409 Participants
Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin \[Hb\] 10-12 grams per deciliter \[g/dL\]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.
|
|---|---|---|
|
Time to All-Cause Mortality
|
6.1 years
Interval 5.6 to 6.5
|
5.9 years
Interval 5.5 to 6.5
|
SECONDARY outcome
Timeframe: Baseline up to approximately 8.5 yearsPopulation: The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment. Analysis was performed on data for participants with an event.
Outcome measures
| Measure |
Erythropoiesis Stimulating Agents
n=1409 Participants
Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta.
|
Methoxy Polyethylene Glycol-Epoetin Beta
n=1409 Participants
Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin \[Hb\] 10-12 grams per deciliter \[g/dL\]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.
|
|---|---|---|
|
Time to Non-Fatal and Fatal Myocardial Infarction
|
NA years
The median time to event was not reached.
|
NA years
The median time to event was not reached.
|
SECONDARY outcome
Timeframe: Baseline up to approximately 8.5 yearsPopulation: The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment. Analysis was performed on data for participants with an event.
Outcome measures
| Measure |
Erythropoiesis Stimulating Agents
n=1409 Participants
Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta.
|
Methoxy Polyethylene Glycol-Epoetin Beta
n=1409 Participants
Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin \[Hb\] 10-12 grams per deciliter \[g/dL\]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.
|
|---|---|---|
|
Time to Non-Fatal and Fatal Stroke
|
NA years
The median time to event was not reached.
|
NA years
The median time to event was not reached.
|
SECONDARY outcome
Timeframe: Baseline up to approximately 8.5 yearsPopulation: The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment. Analysis was performed on data for participants with an event.
Outcome measures
| Measure |
Erythropoiesis Stimulating Agents
n=1409 Participants
Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta.
|
Methoxy Polyethylene Glycol-Epoetin Beta
n=1409 Participants
Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin \[Hb\] 10-12 grams per deciliter \[g/dL\]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.
|
|---|---|---|
|
Time to Non-Fatal Cardiovascular Events (Myocardial Infarction or Stroke, Whichever Occurred First)
|
NA years
The median time to event was not reached.
|
NA years
The median time to event was not reached.
|
SECONDARY outcome
Timeframe: Baseline up to approximately 8.5 yearsPopulation: The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment.
Outcome measures
| Measure |
Erythropoiesis Stimulating Agents
n=1409 Participants
Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta.
|
Methoxy Polyethylene Glycol-Epoetin Beta
n=1409 Participants
Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin \[Hb\] 10-12 grams per deciliter \[g/dL\]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.
|
|---|---|---|
|
Percentage of Participants With Anti-Erythropoietin Antibody-Mediated Pure Red Cell Aplasia (PRCA)
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to approximately 8.5 yearsPopulation: The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment.
Outcome measures
| Measure |
Erythropoiesis Stimulating Agents
n=1409 Participants
Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta.
|
Methoxy Polyethylene Glycol-Epoetin Beta
n=1409 Participants
Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin \[Hb\] 10-12 grams per deciliter \[g/dL\]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.
|
|---|---|---|
|
Percentage of Participants With Gastrointestinal Bleeding
|
11.1 percentage of participants
|
11.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to approximately 8.5 yearsPopulation: The safety population included all participants randomized (with the appropriate signed consent documentation), who received at least one dose of the trial medication and had at least one post-dose safety assessment.
Outcome measures
| Measure |
Erythropoiesis Stimulating Agents
n=1409 Participants
Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta.
|
Methoxy Polyethylene Glycol-Epoetin Beta
n=1409 Participants
Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin \[Hb\] 10-12 grams per deciliter \[g/dL\]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.
|
|---|---|---|
|
Percentage of Participants With Thromboembolic Events
|
34.5 percentage of participants
|
32.8 percentage of participants
|
Adverse Events
Erythropoiesis Stimulating Agents
Serious events: 1123 serious events
Other events: 1171 other events
Deaths: 557 deaths
Methoxy Polyethylene Glycol-Epoetin Beta
Serious events: 1097 serious events
Other events: 1177 other events
Deaths: 558 deaths
Serious adverse events
| Measure |
Erythropoiesis Stimulating Agents
n=1409 participants at risk
Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta.
|
Methoxy Polyethylene Glycol-Epoetin Beta
n=1409 participants at risk
Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin \[Hb\] 10-12 grams per deciliter \[g/dL\]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.
|
|---|---|---|
|
Renal and urinary disorders
Ureteric stenosis
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Renal and urinary disorders
Bladder tamponade
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Renal and urinary disorders
Calculus urethral
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.43%
6/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Renal and urinary disorders
Renal cyst haemorrhage
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Renal and urinary disorders
Hydronephrosis
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Renal and urinary disorders
Renal failure
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Renal and urinary disorders
Renal colic
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Renal and urinary disorders
Urinary retention
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Renal and urinary disorders
Cystitis interstitial
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Renal and urinary disorders
Glomerulonephritis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Renal and urinary disorders
Kidney enlargement
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Renal and urinary disorders
Lupus nephritis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Renal and urinary disorders
Malnutrition-inflammation-atherosclerosis syndrome
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Renal and urinary disorders
Proteinuria
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Renal and urinary disorders
Renal cyst ruptured
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Renal and urinary disorders
Renal haematoma
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Renal and urinary disorders
Renal ischaemia
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Renal and urinary disorders
Urethral stenosis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.3%
19/1409 • Baseline up to approximately 8.5 years
|
1.1%
16/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.57%
8/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.64%
9/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.43%
6/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Neuropathic arthropathy
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Arthrofibrosis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Investigations
Troponin increased
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
High turnover osteopathy
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle necrosis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Sarcopenia
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Sympathetic posterior cervical syndrome
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.71%
10/1409 • Baseline up to approximately 8.5 years
|
0.85%
12/1409 • Baseline up to approximately 8.5 years
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.92%
13/1409 • Baseline up to approximately 8.5 years
|
0.50%
7/1409 • Baseline up to approximately 8.5 years
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.50%
7/1409 • Baseline up to approximately 8.5 years
|
0.57%
8/1409 • Baseline up to approximately 8.5 years
|
|
Hepatobiliary disorders
Cholangitis
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Hepatobiliary disorders
Bile duct stone
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Hepatobiliary disorders
Hepatic failure
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Hepatobiliary disorders
Cholestasis
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Hepatobiliary disorders
Biliary colic
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Hepatobiliary disorders
Cirrhosis alcoholic
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Hepatobiliary disorders
Gallbladder enlargement
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Hepatobiliary disorders
Gallbladder perforation
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Reproductive system and breast disorders
Breast mass
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Hepatobiliary disorders
Haemobilia
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Hepatobiliary disorders
Hepatic artery stenosis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Hepatobiliary disorders
Hydrocholecystis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Hepatobiliary disorders
Liver disorder
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Hepatobiliary disorders
Liver injury
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
1.2%
17/1409 • Baseline up to approximately 8.5 years
|
1.2%
17/1409 • Baseline up to approximately 8.5 years
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.92%
13/1409 • Baseline up to approximately 8.5 years
|
0.78%
11/1409 • Baseline up to approximately 8.5 years
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Skin and subcutaneous tissue disorders
Ischaemic skin ulcer
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Skin and subcutaneous tissue disorders
Pyoderma gangrenosum
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Skin and subcutaneous tissue disorders
Acute generalised exanthematous pustulosis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Skin and subcutaneous tissue disorders
Cholestatic pruritus
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Skin and subcutaneous tissue disorders
Diabetic ulcer
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Skin and subcutaneous tissue disorders
Drug reaction with eosinophilia and systemic symptoms
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Reproductive system and breast disorders
Hysterocele
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Immune system disorders
Drug hypersensitivity
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Immune system disorders
Hypersensitivity
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Immune system disorders
Anti-neutrophil cytoplasmic antibody positive vasculitis
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Immune system disorders
Kidney transplant rejection
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Skin and subcutaneous tissue disorders
Henoch-Schonlein purpura
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Skin and subcutaneous tissue disorders
Neuropathic ulcer
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Immune system disorders
Graft versus host disease
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Immune system disorders
Immune reconstitution inflammatory syndrome
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Immune system disorders
Pancreas transplant rejection
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Immune system disorders
Sarcoidosis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Immune system disorders
Transplant rejection
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Skin and subcutaneous tissue disorders
Vasculitic rash
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
22/1409 • Baseline up to approximately 8.5 years
|
1.8%
25/1409 • Baseline up to approximately 8.5 years
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Blood and lymphatic system disorders
Anaemia of malignant disease
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Ear and labyrinth disorders
Vertigo
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Blood and lymphatic system disorders
Spontaneous haematoma
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Blood and lymphatic system disorders
Bone marrow toxicity
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Ear and labyrinth disorders
Acute vestibular syndrome
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Blood and lymphatic system disorders
Histiocytosis haematophagic
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Blood and lymphatic system disorders
Normochromic anaemia
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Blood and lymphatic system disorders
Spontaneous haemorrhage
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Endocrine disorders
Hyperparathyroidism secondary
|
1.3%
19/1409 • Baseline up to approximately 8.5 years
|
1.6%
23/1409 • Baseline up to approximately 8.5 years
|
|
Endocrine disorders
Hyperparathyroidism tertiary
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Endocrine disorders
Adrenal insufficiency
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Endocrine disorders
Hyperparathyroidism
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Endocrine disorders
Goitre
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Endocrine disorders
Basedow's disease
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Endocrine disorders
Parathyroid hyperplasia
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Psychiatric disorders
Confusional state
|
0.99%
14/1409 • Baseline up to approximately 8.5 years
|
0.71%
10/1409 • Baseline up to approximately 8.5 years
|
|
Psychiatric disorders
Delirium
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Psychiatric disorders
Completed suicide
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Psychiatric disorders
Depression
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Psychiatric disorders
Hallucination
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Psychiatric disorders
Sopor
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Psychiatric disorders
Adjustment disorder
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Psychiatric disorders
Mania
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Psychiatric disorders
Mental status changes
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Psychiatric disorders
Organic brain syndrome
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Psychiatric disorders
Suicide attempt
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Psychiatric disorders
Abnormal behaviour
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Psychiatric disorders
Acute psychosis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Psychiatric disorders
Anxiety
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Psychiatric disorders
Anxiety disorder
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Psychiatric disorders
Mental disorder
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Product Issues
Device malfunction
|
0.50%
7/1409 • Baseline up to approximately 8.5 years
|
0.57%
8/1409 • Baseline up to approximately 8.5 years
|
|
Product Issues
Thrombosis in device
|
0.43%
6/1409 • Baseline up to approximately 8.5 years
|
0.64%
9/1409 • Baseline up to approximately 8.5 years
|
|
Product Issues
Device dislocation
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Product Issues
Device loosening
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Product Issues
Device breakage
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Product Issues
Device damage
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Product Issues
Device extrusion
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Product Issues
Device failure
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Product Issues
Device occlusion
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Eye disorders
Cataract
|
0.64%
9/1409 • Baseline up to approximately 8.5 years
|
0.71%
10/1409 • Baseline up to approximately 8.5 years
|
|
Eye disorders
Vitreous haemorrhage
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Eye disorders
Glaucoma
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Eye disorders
Diabetic retinopathy
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Eye disorders
Retinal artery occlusion
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Eye disorders
Cataract diabetic
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Eye disorders
Endocrine ophthalmopathy
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Eye disorders
Ocular vasculitis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Eye disorders
Papilloedema
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Eye disorders
Retinal neovascularisation
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Eye disorders
Retinal vein thrombosis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Eye disorders
Vision blurred
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Eye disorders
Visual impairment
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Eye disorders
Vitreous haematoma
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Ear and labyrinth disorders
Vertigo labyrinthine
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Investigations
Weight decreased
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Investigations
International normalised ratio increased
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Reproductive system and breast disorders
Prostatitis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Chronic kidney disease-mineral and bone disorder
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Investigations
Coagulation time prolonged
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Collagen disorder
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Investigations
Investigation abnormal
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Congenital, familial and genetic disorders
Congenital cystic kidney disease
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Congenital, familial and genetic disorders
Congenital bladder anomaly
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Congenital, familial and genetic disorders
Nonketotic hyperglycinaemia
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Surgical and medical procedures
Oral surgery
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Strangulated umbilical hernia
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Metabolism and nutrition disorders
Gout
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Renal and urinary disorders
Azotaemia
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.43%
6/1409 • Baseline up to approximately 8.5 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Metabolism and nutrition disorders
Hyperinsulinaemic hypoglycaemia
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Metabolism and nutrition disorders
Haemochromatosis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Metabolism and nutrition disorders
Metabolic disorder
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Metabolism and nutrition disorders
Mitochondrial cytopathy
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Renal and urinary disorders
End stage renal disease
|
2.2%
31/1409 • Baseline up to approximately 8.5 years
|
1.8%
26/1409 • Baseline up to approximately 8.5 years
|
|
Renal and urinary disorders
Renal impairment
|
1.4%
20/1409 • Baseline up to approximately 8.5 years
|
1.3%
18/1409 • Baseline up to approximately 8.5 years
|
|
Renal and urinary disorders
Haematuria
|
0.50%
7/1409 • Baseline up to approximately 8.5 years
|
0.57%
8/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Pneumonia
|
11.6%
163/1409 • Baseline up to approximately 8.5 years
|
12.8%
180/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Sepsis
|
6.0%
85/1409 • Baseline up to approximately 8.5 years
|
4.9%
69/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Peritonitis
|
3.3%
46/1409 • Baseline up to approximately 8.5 years
|
3.3%
47/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Septic shock
|
3.5%
49/1409 • Baseline up to approximately 8.5 years
|
2.6%
36/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Gastroenteritis
|
1.9%
27/1409 • Baseline up to approximately 8.5 years
|
2.8%
39/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Urinary tract infection
|
2.3%
33/1409 • Baseline up to approximately 8.5 years
|
2.2%
31/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Device related sepsis
|
2.1%
30/1409 • Baseline up to approximately 8.5 years
|
1.5%
21/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Lower respiratory tract infection
|
2.0%
28/1409 • Baseline up to approximately 8.5 years
|
1.5%
21/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Cellulitis
|
1.8%
25/1409 • Baseline up to approximately 8.5 years
|
1.6%
22/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Device related infection
|
2.0%
28/1409 • Baseline up to approximately 8.5 years
|
1.3%
19/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Bronchitis
|
1.7%
24/1409 • Baseline up to approximately 8.5 years
|
1.4%
20/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Gangrene
|
1.4%
20/1409 • Baseline up to approximately 8.5 years
|
1.6%
22/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Respiratory tract infection
|
1.6%
23/1409 • Baseline up to approximately 8.5 years
|
1.1%
16/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Staphylococcal sepsis
|
1.3%
18/1409 • Baseline up to approximately 8.5 years
|
0.99%
14/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Urosepsis
|
0.78%
11/1409 • Baseline up to approximately 8.5 years
|
1.3%
19/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Bacteraemia
|
0.99%
14/1409 • Baseline up to approximately 8.5 years
|
0.71%
10/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Arteriovenous fistula site infection
|
0.99%
14/1409 • Baseline up to approximately 8.5 years
|
0.64%
9/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Infection
|
0.50%
7/1409 • Baseline up to approximately 8.5 years
|
1.1%
15/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Upper respiratory tract infection
|
0.71%
10/1409 • Baseline up to approximately 8.5 years
|
0.71%
10/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Diabetic foot infection
|
0.64%
9/1409 • Baseline up to approximately 8.5 years
|
0.71%
10/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Diverticulitis
|
0.92%
13/1409 • Baseline up to approximately 8.5 years
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Erysipelas
|
0.57%
8/1409 • Baseline up to approximately 8.5 years
|
0.71%
10/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Endocarditis
|
0.71%
10/1409 • Baseline up to approximately 8.5 years
|
0.50%
7/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Catheter site infection
|
0.71%
10/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Postoperative wound infection
|
0.71%
10/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Pyelonephritis
|
0.50%
7/1409 • Baseline up to approximately 8.5 years
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.64%
9/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Arteriovenous graft site infection
|
0.50%
7/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Arthritis bacterial
|
0.57%
8/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Infected skin ulcer
|
0.57%
8/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Lung infection
|
0.57%
8/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Viral infection
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.57%
8/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Pyelonephritis acute
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Wound infection
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.43%
6/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Escherichia sepsis
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Localised infection
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Pneumonia bacterial
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Pulmonary sepsis
|
0.50%
7/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Staphylococcal infection
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.57%
8/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Influenza
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Osteomyelitis
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Peritonitis bacterial
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Clostridium difficile colitis
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Herpes zoster
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Necrotising fasciitis
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Renal cyst infection
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Appendicitis
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Bacterial sepsis
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Cystitis
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Diabetic gangrene
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Enterococcal sepsis
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Abdominal abscess
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Abscess limb
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Anal abscess
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Diverticulitis intestinal haemorrhagic
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Infectious colitis
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Infectious pleural effusion
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Pseudomonal sepsis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Soft tissue infection
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Abscess
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Biliary sepsis
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Fungal peritonitis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Gastroenteritis viral
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Graft infection
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
H1N1 influenza
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Pseudomembranous colitis
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Pyelonephritis chronic
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Acute sinusitis
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Cellulitis gangrenous
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Cholangitis infective
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Gastroenteritis clostridial
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Intervertebral discitis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Post procedural infection
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Post procedural sepsis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Pyonephrosis
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Septic necrosis
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Sialoadenitis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Streptococcal sepsis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Subcutaneous abscess
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Tonsillitis
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Wound sepsis
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Abdominal sepsis
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Appendicitis perforated
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Arteriosclerotic gangrene
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Atypical pneumonia
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Bacterial infection
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Clostridium difficile infection
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Empyema
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Encephalitis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Endocarditis bacterial
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Endocarditis staphylococcal
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Enterobacter sepsis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Epididymitis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Epiglottitis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Fungal oesophagitis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Groin abscess
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Haematoma infection
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Haemophilus infection
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Joint tuberculosis
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Klebsiella sepsis
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Listeriosis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Lymph node tuberculosis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Osteomyelitis chronic
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Otitis media
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Pneumococcal sepsis
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Pneumonia klebsiella
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Proteus infection
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Renal graft infection
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Retroperitoneal abscess
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Septic arthritis staphylococcal
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Sinusitis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Skin bacterial infection
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Staphylococcal skin infection
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Systemic candida
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Tuberculosis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Abdominal wall infection
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Abscess jaw
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Appendiceal abscess
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Atypical mycobacterial infection
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Bacterial colitis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Bacterial diarrhoea
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Bone abscess
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Bone tuberculosis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Cat scratch disease
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Catheter site abscess
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Chronic tonsillitis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Citrobacter sepsis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Colon gangrene
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Colonic abscess
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Corneal abscess
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Corynebacterium sepsis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Cystitis bacterial
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Dacryocystitis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Disseminated tuberculosis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Endophthalmitis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Enteritis infectious
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Escherichia infection
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Escherichia pyelonephritis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Febrile infection
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Gastrointestinal infection
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Genitourinary tract infection
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Hepatic cyst infection
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Herpes sepsis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Herpes zoster meningoencephalitis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Implant site infection
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Infected bunion
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Infected dermal cyst
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Infected fistula
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Infective gastroduodenitis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Injection site infection
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Intestinal fistula infection
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Joint abscess
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Listeria encephalitis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Liver abscess
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Lung abscess
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Mesenteric abscess
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Muscle abscess
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Mycetoma mycotic
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Nail infection
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Nasopharyngitis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Nosocomial infection
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Osteomyelitis acute
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Otitis externa
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Parotitis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Perihepatic abscess
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Periodontal destruction
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Periodontitis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Peritonsillar abscess
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Pneumonia necrotising
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Postoperative abscess
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Pyomyositis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Renal abscess
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Rotavirus infection
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Salmonellosis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Salpingitis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Seminal vesicle abscess
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Skin infection
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Staphylococcal abscess
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Subacute endocarditis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Tubo-ovarian abscess
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Urethral abscess
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Urinary tract infection staphylococcal
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Vaginal infection
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Varicella
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Acute myocardial infarction
|
5.3%
74/1409 • Baseline up to approximately 8.5 years
|
4.5%
63/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Atrial fibrillation
|
4.0%
57/1409 • Baseline up to approximately 8.5 years
|
3.5%
49/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Myocardial infarction
|
3.5%
50/1409 • Baseline up to approximately 8.5 years
|
3.8%
54/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Cardiac arrest
|
3.1%
44/1409 • Baseline up to approximately 8.5 years
|
3.9%
55/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Angina pectoris
|
2.6%
37/1409 • Baseline up to approximately 8.5 years
|
2.5%
35/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Cardiac failure
|
2.4%
34/1409 • Baseline up to approximately 8.5 years
|
1.8%
25/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Acute coronary syndrome
|
1.8%
25/1409 • Baseline up to approximately 8.5 years
|
2.1%
29/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Cardiac failure congestive
|
1.7%
24/1409 • Baseline up to approximately 8.5 years
|
1.4%
20/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Coronary artery disease
|
1.7%
24/1409 • Baseline up to approximately 8.5 years
|
1.4%
20/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Angina unstable
|
1.1%
16/1409 • Baseline up to approximately 8.5 years
|
1.7%
24/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Myocardial ischaemia
|
1.5%
21/1409 • Baseline up to approximately 8.5 years
|
1.2%
17/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Bradycardia
|
1.4%
20/1409 • Baseline up to approximately 8.5 years
|
0.57%
8/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.85%
12/1409 • Baseline up to approximately 8.5 years
|
0.71%
10/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Aortic valve stenosis
|
0.57%
8/1409 • Baseline up to approximately 8.5 years
|
0.57%
8/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Atrioventricular block complete
|
0.50%
7/1409 • Baseline up to approximately 8.5 years
|
0.64%
9/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Coronary artery stenosis
|
0.50%
7/1409 • Baseline up to approximately 8.5 years
|
0.64%
9/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Cardiogenic shock
|
0.64%
9/1409 • Baseline up to approximately 8.5 years
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Atrial flutter
|
0.64%
9/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Cardiac failure acute
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.64%
9/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.57%
8/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Ventricular fibrillation
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.50%
7/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Arrhythmia
|
0.50%
7/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Left ventricular failure
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Cardiac failure chronic
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Atrioventricular block
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Cardiomyopathy
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Sinus node dysfunction
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Ventricular tachycardia
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Aortic valve disease
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Atrial tachycardia
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Pericardial effusion
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Pericarditis
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Sinus bradycardia
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Acute left ventricular failure
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Atrial thrombosis
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Bradyarrhythmia
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Right ventricular failure
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Tachyarrhythmia
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Aortic valve disease mixed
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Pericarditis uraemic
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Pulseless electrical activity
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Adams-Stokes syndrome
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Bundle branch block left
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Cardiac dysfunction
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Cardiac tamponade
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Chordae tendinae rupture
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Coronary artery dissection
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Coronary artery occlusion
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Diabetic cardiomyopathy
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Dressler's syndrome
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Heart valve incompetence
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Heart valve stenosis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Hypertensive heart disease
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Low cardiac output syndrome
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Mitral valve stenosis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Palpitations
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Paroxysmal atrioventricular block
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Sinoatrial block
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Tachycardia
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Torsade de pointes
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Ventricular dyssynchrony
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Ventricular tachyarrhythmia
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
7.8%
110/1409 • Baseline up to approximately 8.5 years
|
5.5%
77/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
4.0%
57/1409 • Baseline up to approximately 8.5 years
|
3.3%
47/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.6%
23/1409 • Baseline up to approximately 8.5 years
|
1.8%
26/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
1.1%
16/1409 • Baseline up to approximately 8.5 years
|
1.6%
23/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Arteriovenous graft thrombosis
|
0.92%
13/1409 • Baseline up to approximately 8.5 years
|
1.6%
23/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
1.3%
19/1409 • Baseline up to approximately 8.5 years
|
0.99%
14/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.92%
13/1409 • Baseline up to approximately 8.5 years
|
1.1%
16/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula aneurysm
|
1.1%
15/1409 • Baseline up to approximately 8.5 years
|
0.43%
6/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.57%
8/1409 • Baseline up to approximately 8.5 years
|
0.85%
12/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.57%
8/1409 • Baseline up to approximately 8.5 years
|
0.78%
11/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.78%
11/1409 • Baseline up to approximately 8.5 years
|
0.50%
7/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.57%
8/1409 • Baseline up to approximately 8.5 years
|
0.64%
9/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Head injury
|
0.64%
9/1409 • Baseline up to approximately 8.5 years
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.50%
7/1409 • Baseline up to approximately 8.5 years
|
0.50%
7/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.57%
8/1409 • Baseline up to approximately 8.5 years
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
0.57%
8/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Overdose
|
0.43%
6/1409 • Baseline up to approximately 8.5 years
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.57%
8/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.50%
7/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.43%
6/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Arteriovenous graft site stenosis
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.43%
6/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haematoma
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Contusion
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Arterial bypass thrombosis
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Arteriovenous graft site haemorrhage
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Concussion
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Peritoneal dialysis complication
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Perirenal haematoma
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Wound necrosis
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Arteriovenous graft aneurysm
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Arteriovenous graft site haematoma
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Face injury
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Graft haemorrhage
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Postoperative hernia
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Procedural intestinal perforation
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Shunt aneurysm
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Shunt stenosis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Arterial bypass occlusion
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula occlusion
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Bone fissure
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Cardiac valve replacement complication
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Complications of transplant surgery
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Device deployment issue
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Dislocation of vertebra
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Eschar
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Extensive interdialytic weight gain
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Haemodialysis complication
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Hyphaema
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Incarcerated incisional hernia
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Intestinal anastomosis complication
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Kidney rupture
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Peripheral artery restenosis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Postoperative delirium
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Postpericardiotomy syndrome
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Procedural hypertension
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Radiation proctitis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Splenic injury
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Stoma site haemorrhage
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Stomal hernia
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Traumatic coma
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Traumatic haemorrhage
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Vascular bypass dysfunction
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Vasoplegia syndrome
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Wound
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.6%
23/1409 • Baseline up to approximately 8.5 years
|
1.7%
24/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
16/1409 • Baseline up to approximately 8.5 years
|
0.92%
13/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Diarrhoea
|
0.64%
9/1409 • Baseline up to approximately 8.5 years
|
1.3%
18/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.71%
10/1409 • Baseline up to approximately 8.5 years
|
0.64%
9/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.57%
8/1409 • Baseline up to approximately 8.5 years
|
0.71%
10/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Gastritis
|
0.78%
11/1409 • Baseline up to approximately 8.5 years
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Constipation
|
0.57%
8/1409 • Baseline up to approximately 8.5 years
|
0.50%
7/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
0.71%
10/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.50%
7/1409 • Baseline up to approximately 8.5 years
|
0.57%
8/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.50%
7/1409 • Baseline up to approximately 8.5 years
|
0.50%
7/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.57%
8/1409 • Baseline up to approximately 8.5 years
|
0.43%
6/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.64%
9/1409 • Baseline up to approximately 8.5 years
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.64%
9/1409 • Baseline up to approximately 8.5 years
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Melaena
|
0.50%
7/1409 • Baseline up to approximately 8.5 years
|
0.50%
7/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Colitis
|
0.57%
8/1409 • Baseline up to approximately 8.5 years
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.64%
9/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Pancreatitis
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
0.43%
6/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.43%
6/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.43%
6/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.43%
6/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.43%
6/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.50%
7/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.50%
7/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Diverticulum
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Enteritis
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Vomiting
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia haemorrhagic
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Haematemesis
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Haematochezia
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Enterocolitis
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Subileus
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Acute abdomen
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Anal fistula
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Encapsulating peritoneal sclerosis
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Gastric antral vascular ectasia
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Gastrointestinal angiectasia
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Gastrointestinal polyp haemorrhage
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Haemorrhagic erosive gastritis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Ileus
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Large intestinal ulcer haemorrhage
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Necrotising colitis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Oesophagitis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Pancreatitis necrotising
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Colitis erosive
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Dental caries
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Erosive duodenitis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Food poisoning
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Large intestinal ulcer
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Peritoneal perforation
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Rectal polyp
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Abdominal wall haemorrhage
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Anal fissure
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Anal stenosis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Anal ulcer
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Anorectal varices
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Appendiceal mucocoele
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Diabetic gastropathy
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Diverticulum oesophageal
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Duodenitis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Enterocolitis haemorrhagic
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Faecaloma
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Gallstone ileus
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Gastroduodenal ulcer
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Gastrointestinal hypomotility
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Ileal perforation
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Inguinal hernia strangulated
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Intestinal angina
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Intestinal mass
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Intestinal pseudo-obstruction
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Intestinal varices
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Intra-abdominal fluid collection
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Ischaemic enteritis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Lumbar hernia
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Mesenteric arterial occlusion
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Nausea
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Oesophagitis haemorrhagic
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Peptic ulcer perforation
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Rectal ulcer haemorrhage
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Reflux gastritis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Salivary gland enlargement
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Tongue oedema
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Umbilical hernia, obstructive
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Volvulus
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Peripheral ischaemia
|
2.2%
31/1409 • Baseline up to approximately 8.5 years
|
2.2%
31/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
1.7%
24/1409 • Baseline up to approximately 8.5 years
|
1.7%
24/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Hypertension
|
1.7%
24/1409 • Baseline up to approximately 8.5 years
|
1.6%
23/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Hypotension
|
1.3%
18/1409 • Baseline up to approximately 8.5 years
|
1.1%
16/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Extremity necrosis
|
0.92%
13/1409 • Baseline up to approximately 8.5 years
|
0.71%
10/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Hypertensive crisis
|
0.57%
8/1409 • Baseline up to approximately 8.5 years
|
0.92%
13/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Peripheral artery stenosis
|
0.57%
8/1409 • Baseline up to approximately 8.5 years
|
0.85%
12/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Peripheral vascular disorder
|
0.78%
11/1409 • Baseline up to approximately 8.5 years
|
0.64%
9/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Aortic stenosis
|
0.78%
11/1409 • Baseline up to approximately 8.5 years
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Deep vein thrombosis
|
0.64%
9/1409 • Baseline up to approximately 8.5 years
|
0.50%
7/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Orthostatic hypotension
|
0.50%
7/1409 • Baseline up to approximately 8.5 years
|
0.57%
8/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Haematoma
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
0.64%
9/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Shock haemorrhagic
|
0.43%
6/1409 • Baseline up to approximately 8.5 years
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Aortic aneurysm
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Steal syndrome
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.57%
8/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Dry gangrene
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Intermittent claudication
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Peripheral artery occlusion
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Venous stenosis
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Circulatory collapse
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Brachiocephalic vein stenosis
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Angiopathy
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Arterial disorder
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Granulomatosis with polyangiitis
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Hypovolaemic shock
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Vena cava thrombosis
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Venous thrombosis limb
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Arterial occlusive disease
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Shock
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Superior vena cava syndrome
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Thrombosis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Angiodysplasia
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Aortic dissection
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Arterial haemorrhage
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Arterial rupture
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Arteriosclerosis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Brachiocephalic vein thrombosis
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Diabetic macroangiopathy
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Diabetic vascular disorder
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Haemorrhage
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Hypertensive emergency
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Leriche syndrome
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Peripheral embolism
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Phlebitis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Subclavian vein stenosis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Thrombophlebitis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Vascular calcification
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Aneurysm
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Aortic thrombosis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Arterial stenosis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Femoral artery dissection
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Haemorrhagic infarction
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Ischaemia
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Ischaemic limb pain
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Lymphatic fistula
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Lymphostasis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Microangiopathy
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Microscopic polyangiitis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Varicose vein
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Vascular stenosis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Vasculitis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Vasculitis necrotising
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Venous aneurysm
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Ischaemic stroke
|
2.0%
28/1409 • Baseline up to approximately 8.5 years
|
1.5%
21/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Cerebrovascular accident
|
1.6%
23/1409 • Baseline up to approximately 8.5 years
|
1.7%
24/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Transient ischaemic attack
|
1.2%
17/1409 • Baseline up to approximately 8.5 years
|
2.1%
30/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Syncope
|
1.6%
22/1409 • Baseline up to approximately 8.5 years
|
1.1%
15/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.50%
7/1409 • Baseline up to approximately 8.5 years
|
0.57%
8/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Seizure
|
0.71%
10/1409 • Baseline up to approximately 8.5 years
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Cerebral infarction
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.64%
9/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Dizziness
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.64%
9/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.50%
7/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Cerebral ischaemia
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.43%
6/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.50%
7/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Dementia
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Sciatica
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Epilepsy
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Headache
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Carotid artery stenosis
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Vascular dementia
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Presyncope
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Thrombotic stroke
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Altered state of consciousness
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Cerebral haematoma
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Facial paralysis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Stupor
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Aphasia
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Ataxia
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Brain stem infarction
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Dyskinesia
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Encephalopathy
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Intracranial aneurysm
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Lacunar infarction
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Polyneuropathy
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Balance disorder
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Brain hypoxia
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Brain injury
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Cauda equina syndrome
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Cerebellar stroke
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Cerebral arteriosclerosis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Cerebral ataxia
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Cerebral small vessel ischaemic disease
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Cognitive disorder
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Dementia with Lewy bodies
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Demyelination
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Diabetic hyperosmolar coma
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Diabetic mononeuropathy
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Essential tremor
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Facial paresis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Hemianopia homonymous
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Hypocalcaemic seizure
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Hypoglycaemic seizure
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Hypoglycaemic unconsciousness
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
IIIrd nerve paralysis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Ischaemic neuropathy
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
IVth nerve paresis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Lacunar stroke
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Lethargy
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Memory impairment
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Migraine
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Monoparesis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Movement disorder
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Myoclonic epilepsy
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Nerve root compression
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Nervous system disorder
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Noninfective encephalitis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Paraparesis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Retrograde amnesia
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Reversible ischaemic neurological deficit
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Somnolence
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Spinal subarachnoid haemorrhage
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Tension headache
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Thalamus haemorrhage
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Transient global amnesia
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
VIth nerve paralysis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Wallerian degeneration
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Death
|
2.3%
33/1409 • Baseline up to approximately 8.5 years
|
2.8%
39/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Sudden death
|
1.8%
26/1409 • Baseline up to approximately 8.5 years
|
3.1%
44/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Pyrexia
|
2.1%
30/1409 • Baseline up to approximately 8.5 years
|
1.8%
26/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
General physical health deterioration
|
1.1%
16/1409 • Baseline up to approximately 8.5 years
|
0.85%
12/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Chest pain
|
0.92%
13/1409 • Baseline up to approximately 8.5 years
|
0.71%
10/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Catheter site haemorrhage
|
0.50%
7/1409 • Baseline up to approximately 8.5 years
|
0.50%
7/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Non-cardiac chest pain
|
0.78%
11/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Asthenia
|
0.50%
7/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Inflammation
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.43%
6/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Complication associated with device
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Sudden cardiac death
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Hyperthermia
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Adverse drug reaction
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Device related thrombosis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Hyperpyrexia
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Malaise
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Oedema due to renal disease
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Fatigue
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Hernia
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Oedema peripheral
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Swelling
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Catheter site inflammation
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Chest discomfort
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Gait disturbance
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Oedema
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Strangulated hernia
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Systemic inflammatory response syndrome
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Accidental death
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Discomfort
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Drug intolerance
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Dysplasia
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Heteroplasia
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Impaired healing
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Implant site extravasation
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Incarcerated hernia
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Injection site extravasation
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Injection site scab
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Medical device pain
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Mucosal ulceration
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Necrosis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Oedema due to cardiac disease
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Pseudocyst
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Stent-graft endoleak
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Surgical failure
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Treatment failure
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Vascular stent restenosis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Vascular stent stenosis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Vascular stent thrombosis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Vessel puncture site haematoma
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.6%
22/1409 • Baseline up to approximately 8.5 years
|
1.6%
22/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Non-cardiogenic pulmonary oedema
|
1.6%
23/1409 • Baseline up to approximately 8.5 years
|
1.1%
15/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.99%
14/1409 • Baseline up to approximately 8.5 years
|
1.1%
16/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.85%
12/1409 • Baseline up to approximately 8.5 years
|
1.3%
18/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.99%
14/1409 • Baseline up to approximately 8.5 years
|
0.78%
11/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.78%
11/1409 • Baseline up to approximately 8.5 years
|
0.85%
12/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.50%
7/1409 • Baseline up to approximately 8.5 years
|
0.92%
13/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.64%
9/1409 • Baseline up to approximately 8.5 years
|
0.57%
8/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.64%
9/1409 • Baseline up to approximately 8.5 years
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.57%
8/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
0.43%
6/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.43%
6/1409 • Baseline up to approximately 8.5 years
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.50%
7/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial disorder
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute lung injury
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal effusion
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.50%
7/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Mendelson's syndrome
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum perforation
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Reflux laryngitis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.43%
6/1409 • Baseline up to approximately 8.5 years
|
0.57%
8/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.43%
6/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.43%
6/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.43%
6/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal adenocarcinoma
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder papilloma
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone neoplasm
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic carcinoma of the bladder
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer metastatic
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myelomonocytic leukaemia
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign lung neoplasm
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of bladder
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of epididymis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign urinary tract neoplasm
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma metastatic
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the duodenum
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the stomach
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma in situ of penis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system lymphoma
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system neoplasm
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cerebral hygroma
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix cancer metastatic
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Choroid melanoma
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Connective tissue neoplasm
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ear neoplasm malignant
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial neoplasm
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extranodal marginal zone B-cell lymphoma (malt type)
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder adenocarcinoma
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioma
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal papilloma
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma metastatic
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant fibrous histiocytoma
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic carcinoid tumour
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelofibrosis
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma metastatic
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oligodendroglioma
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paget's disease of nipple
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pelvic neoplasm
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma recurrent
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer metastatic
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer recurrent
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Refractory cytopenia with unilineage dysplasia
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma recurrent
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal haemangioma
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the oral cavity
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testicular neoplasm
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thymoma
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell cancer of renal pelvis and ureter metastatic
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma urethra
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urinary bladder adenoma
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.00%
0/1409 • Baseline up to approximately 8.5 years
|
|
Metabolism and nutrition disorders
Fluid overload
|
3.1%
44/1409 • Baseline up to approximately 8.5 years
|
3.1%
43/1409 • Baseline up to approximately 8.5 years
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.3%
18/1409 • Baseline up to approximately 8.5 years
|
2.3%
32/1409 • Baseline up to approximately 8.5 years
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.85%
12/1409 • Baseline up to approximately 8.5 years
|
1.2%
17/1409 • Baseline up to approximately 8.5 years
|
|
Metabolism and nutrition disorders
Cachexia
|
0.64%
9/1409 • Baseline up to approximately 8.5 years
|
0.71%
10/1409 • Baseline up to approximately 8.5 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.64%
9/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.50%
7/1409 • Baseline up to approximately 8.5 years
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
0.35%
5/1409 • Baseline up to approximately 8.5 years
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.43%
6/1409 • Baseline up to approximately 8.5 years
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Metabolism and nutrition disorders
Calciphylaxis
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Metabolism and nutrition disorders
Diabetic complication
|
0.07%
1/1409 • Baseline up to approximately 8.5 years
|
0.28%
4/1409 • Baseline up to approximately 8.5 years
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.14%
2/1409 • Baseline up to approximately 8.5 years
|
0.21%
3/1409 • Baseline up to approximately 8.5 years
|
Other adverse events
| Measure |
Erythropoiesis Stimulating Agents
n=1409 participants at risk
Participants received reference ESA according to approved label. No biosimilar ESAs were accepted in the study. The approved reference ESA compounds in the study were darbepoetin alfa, epoetin alfa and epoetin beta.
|
Methoxy Polyethylene Glycol-Epoetin Beta
n=1409 participants at risk
Participants not currently being treated with an ESA received 0.6 micrograms per kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta intravenously (iv) or subcutaneously (sc) once every 2 weeks for correction of renal anemia (target hemoglobin \[Hb\] 10-12 grams per deciliter \[g/dL\]). Participants currently treated with an ESA received a starting dose of 120, 200 or 360 mcg/kg methoxy polyethylene glycol-epoetin beta iv or sc once monthly based on the calculated weekly ESA dose prior to the switch for maintenance of anemia treatment. Once corrected and in participants currently being treated with an ESA, methoxy polyethylene glycol-epoetin beta was administered once monthly.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
12.1%
171/1409 • Baseline up to approximately 8.5 years
|
13.3%
187/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Bronchitis
|
13.8%
195/1409 • Baseline up to approximately 8.5 years
|
13.3%
188/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Urinary tract infection
|
13.7%
193/1409 • Baseline up to approximately 8.5 years
|
14.2%
200/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Upper respiratory tract infection
|
10.9%
153/1409 • Baseline up to approximately 8.5 years
|
9.4%
132/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Gastroenteritis
|
6.6%
93/1409 • Baseline up to approximately 8.5 years
|
7.2%
101/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Pneumonia
|
7.2%
101/1409 • Baseline up to approximately 8.5 years
|
5.6%
79/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Respiratory tract infection
|
5.4%
76/1409 • Baseline up to approximately 8.5 years
|
5.0%
70/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Lower respiratory tract infection
|
3.9%
55/1409 • Baseline up to approximately 8.5 years
|
5.3%
74/1409 • Baseline up to approximately 8.5 years
|
|
Infections and infestations
Influenza
|
5.9%
83/1409 • Baseline up to approximately 8.5 years
|
5.1%
72/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Diarrhoea
|
19.1%
269/1409 • Baseline up to approximately 8.5 years
|
19.4%
273/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Constipation
|
12.3%
173/1409 • Baseline up to approximately 8.5 years
|
10.1%
142/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Vomiting
|
10.4%
146/1409 • Baseline up to approximately 8.5 years
|
8.6%
121/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Nausea
|
7.0%
99/1409 • Baseline up to approximately 8.5 years
|
7.4%
104/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
88/1409 • Baseline up to approximately 8.5 years
|
7.2%
102/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.0%
70/1409 • Baseline up to approximately 8.5 years
|
5.8%
82/1409 • Baseline up to approximately 8.5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
5.5%
78/1409 • Baseline up to approximately 8.5 years
|
4.2%
59/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
15.0%
211/1409 • Baseline up to approximately 8.5 years
|
14.1%
199/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.2%
158/1409 • Baseline up to approximately 8.5 years
|
8.4%
119/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.4%
133/1409 • Baseline up to approximately 8.5 years
|
8.8%
124/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.8%
110/1409 • Baseline up to approximately 8.5 years
|
8.9%
125/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
7.5%
105/1409 • Baseline up to approximately 8.5 years
|
6.1%
86/1409 • Baseline up to approximately 8.5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.6%
79/1409 • Baseline up to approximately 8.5 years
|
5.1%
72/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Hypertension
|
30.7%
432/1409 • Baseline up to approximately 8.5 years
|
32.3%
455/1409 • Baseline up to approximately 8.5 years
|
|
Vascular disorders
Hypotension
|
10.1%
143/1409 • Baseline up to approximately 8.5 years
|
8.8%
124/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
16.0%
225/1409 • Baseline up to approximately 8.5 years
|
15.8%
223/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
12.1%
171/1409 • Baseline up to approximately 8.5 years
|
11.2%
158/1409 • Baseline up to approximately 8.5 years
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
6.2%
87/1409 • Baseline up to approximately 8.5 years
|
6.1%
86/1409 • Baseline up to approximately 8.5 years
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
9.9%
140/1409 • Baseline up to approximately 8.5 years
|
8.7%
122/1409 • Baseline up to approximately 8.5 years
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
10.1%
142/1409 • Baseline up to approximately 8.5 years
|
9.7%
136/1409 • Baseline up to approximately 8.5 years
|
|
Metabolism and nutrition disorders
Fluid overload
|
9.2%
130/1409 • Baseline up to approximately 8.5 years
|
8.2%
115/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.8%
194/1409 • Baseline up to approximately 8.5 years
|
11.5%
162/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.7%
109/1409 • Baseline up to approximately 8.5 years
|
7.7%
109/1409 • Baseline up to approximately 8.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.1%
72/1409 • Baseline up to approximately 8.5 years
|
3.5%
50/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Pyrexia
|
6.8%
96/1409 • Baseline up to approximately 8.5 years
|
6.5%
92/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Oedema due to renal disease
|
5.6%
79/1409 • Baseline up to approximately 8.5 years
|
5.5%
78/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Asthenia
|
4.2%
59/1409 • Baseline up to approximately 8.5 years
|
6.0%
85/1409 • Baseline up to approximately 8.5 years
|
|
General disorders
Oedema peripheral
|
5.2%
73/1409 • Baseline up to approximately 8.5 years
|
4.3%
61/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Headache
|
9.0%
127/1409 • Baseline up to approximately 8.5 years
|
10.0%
141/1409 • Baseline up to approximately 8.5 years
|
|
Nervous system disorders
Dizziness
|
5.5%
78/1409 • Baseline up to approximately 8.5 years
|
5.7%
81/1409 • Baseline up to approximately 8.5 years
|
|
Psychiatric disorders
Insomnia
|
8.2%
116/1409 • Baseline up to approximately 8.5 years
|
7.4%
104/1409 • Baseline up to approximately 8.5 years
|
|
Psychiatric disorders
Depression
|
4.6%
65/1409 • Baseline up to approximately 8.5 years
|
5.3%
75/1409 • Baseline up to approximately 8.5 years
|
|
Blood and lymphatic system disorders
Anaemia
|
10.1%
143/1409 • Baseline up to approximately 8.5 years
|
12.3%
174/1409 • Baseline up to approximately 8.5 years
|
|
Endocrine disorders
Hyperparathyroidism secondary
|
10.6%
149/1409 • Baseline up to approximately 8.5 years
|
10.5%
148/1409 • Baseline up to approximately 8.5 years
|
|
Cardiac disorders
Atrial fibrillation
|
8.7%
123/1409 • Baseline up to approximately 8.5 years
|
7.9%
111/1409 • Baseline up to approximately 8.5 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.4%
118/1409 • Baseline up to approximately 8.5 years
|
8.1%
114/1409 • Baseline up to approximately 8.5 years
|
|
Eye disorders
Cataract
|
5.1%
72/1409 • Baseline up to approximately 8.5 years
|
5.4%
76/1409 • Baseline up to approximately 8.5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER