Trial Outcomes & Findings for Cardiovascular Safety of Febuxostat and Allopurinol in Participants With Gout and Cardiovascular Comorbidities (CARES) (NCT NCT01101035)
NCT ID: NCT01101035
Last Updated: 2018-06-14
Results Overview
Major adverse cardiovascular events (MACE) were defined as a composite of cardiovascular (CV) death, non-fatal myocardial infarction (MI), nonfatal stroke and unstable angina with urgent coronary revascularization; these events were adjudicated by an independent cardiovascular endpoints committee.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
6198 participants
Primary outcome timeframe
Up to last dose of study drug (approximately 83 months)
Results posted on
2018-06-14
Participant Flow
Participants took part in the study at 320 investigative sites in Canada, Mexico and United States from 23 April 2010 to 18 July 2017.
Participants with a diagnosis of gout and significant cardiovascular comorbidities were enrolled in a 1:1 ratio to receive either febuxostat or allopurinol.
Participant milestones
| Measure |
Febuxostat
Febuxostat 40 mg (or 80 mg beginning on week 4 if serum uric acid level was ≥6.0 mg/dL), tablets, orally, once daily for up to approximately 82 months.
|
Allopurinol
Allopurinol 300 mg to 600 mg (increased in 100 mg increments each month until serum uric acid was \<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with mildly impaired renal function or normal renal function (estimated creatinine clearance \[eCLcr\] ≥60 mL/min) or allopurinol 200 mg to 400 mg (increased in 100 mg increments each month until serum uric acid was \<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with moderately impaired renal function (eCLcr ≥30 but \<60 mL/min).
|
|---|---|---|
|
Overall Study
STARTED
|
3101
|
3097
|
|
Overall Study
COMPLETED
|
1704
|
1706
|
|
Overall Study
NOT COMPLETED
|
1397
|
1391
|
Reasons for withdrawal
| Measure |
Febuxostat
Febuxostat 40 mg (or 80 mg beginning on week 4 if serum uric acid level was ≥6.0 mg/dL), tablets, orally, once daily for up to approximately 82 months.
|
Allopurinol
Allopurinol 300 mg to 600 mg (increased in 100 mg increments each month until serum uric acid was \<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with mildly impaired renal function or normal renal function (estimated creatinine clearance \[eCLcr\] ≥60 mL/min) or allopurinol 200 mg to 400 mg (increased in 100 mg increments each month until serum uric acid was \<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with moderately impaired renal function (eCLcr ≥30 but \<60 mL/min).
|
|---|---|---|
|
Overall Study
Adverse Event
|
191
|
172
|
|
Overall Study
Major Protocol Deviation
|
52
|
46
|
|
Overall Study
Lost to Follow-up
|
226
|
223
|
|
Overall Study
Voluntary Withdrawal
|
595
|
587
|
|
Overall Study
Reason not Specified
|
333
|
363
|
Baseline Characteristics
Here, number analyzed indicates participants who were evaluated for this baseline characteristic.
Baseline characteristics by cohort
| Measure |
Febuxostat
n=3098 Participants
Febuxostat 40 mg (or 80 mg beginning on week 4 if serum uric acid level was ≥6.0 mg/dL), tablets, orally, once daily for up to approximately 82 months.
|
Allopurinol
n=3092 Participants
Allopurinol 300 mg to 600 mg (increased in 100 mg increments each month until serum uric acid was \<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with mildly impaired renal function or normal renal function (estimated creatinine clearance \[eCLcr\] ≥60 mL/min) or allopurinol 200 mg to 400 mg (increased in 100 mg increments each month until serum uric acid was \<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with moderately impaired renal function (eCLcr ≥30 but \<60 mL/min).
|
Total
n=6190 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.6 years
STANDARD_DEVIATION 8.58 • n=3098 Participants
|
65.0 years
STANDARD_DEVIATION 8.49 • n=3092 Participants
|
64.8 years
STANDARD_DEVIATION 8.53 • n=6190 Participants
|
|
Age, Customized
<65 years
|
1584 Participants
n=3098 Participants
|
1506 Participants
n=3092 Participants
|
3090 Participants
n=6190 Participants
|
|
Age, Customized
65 to <75 years
|
1094 Participants
n=3098 Participants
|
1135 Participants
n=3092 Participants
|
2229 Participants
n=6190 Participants
|
|
Age, Customized
≥75 years
|
420 Participants
n=3098 Participants
|
451 Participants
n=3092 Participants
|
871 Participants
n=6190 Participants
|
|
Sex: Female, Male
Female
|
494 Participants
n=3098 Participants
|
500 Participants
n=3092 Participants
|
994 Participants
n=6190 Participants
|
|
Sex: Female, Male
Male
|
2604 Participants
n=3098 Participants
|
2592 Participants
n=3092 Participants
|
5196 Participants
n=6190 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
262 Participants
n=3098 Participants
|
234 Participants
n=3092 Participants
|
496 Participants
n=6190 Participants
|
|
Race/Ethnicity, Customized
Asian
|
92 Participants
n=3098 Participants
|
96 Participants
n=3092 Participants
|
188 Participants
n=6190 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
552 Participants
n=3098 Participants
|
593 Participants
n=3092 Participants
|
1145 Participants
n=6190 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
13 Participants
n=3098 Participants
|
14 Participants
n=3092 Participants
|
27 Participants
n=6190 Participants
|
|
Race/Ethnicity, Customized
White
|
2160 Participants
n=3098 Participants
|
2140 Participants
n=3092 Participants
|
4300 Participants
n=6190 Participants
|
|
Race/Ethnicity, Customized
Other
|
19 Participants
n=3098 Participants
|
15 Participants
n=3092 Participants
|
34 Participants
n=6190 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
539 Participants
n=3098 Participants
|
521 Participants
n=3092 Participants
|
1060 Participants
n=6190 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
2559 Participants
n=3098 Participants
|
2571 Participants
n=3092 Participants
|
5130 Participants
n=6190 Participants
|
|
Region of Enrollment
Canada
|
68 Participants
n=3098 Participants
|
72 Participants
n=3092 Participants
|
140 Participants
n=6190 Participants
|
|
Region of Enrollment
Mexico
|
379 Participants
n=3098 Participants
|
355 Participants
n=3092 Participants
|
734 Participants
n=6190 Participants
|
|
Region of Enrollment
United States
|
2651 Participants
n=3098 Participants
|
2665 Participants
n=3092 Participants
|
5316 Participants
n=6190 Participants
|
|
Height
|
172.9 cm
STANDARD_DEVIATION 9.54 • n=3098 Participants
|
173.0 cm
STANDARD_DEVIATION 9.77 • n=3092 Participants
|
173.0 cm
STANDARD_DEVIATION 9.65 • n=6190 Participants
|
|
Weight
|
100.5 kg
STANDARD_DEVIATION 22.47 • n=3098 Participants • Here, number analyzed indicates participants who were evaluated for this baseline characteristic.
|
100.3 kg
STANDARD_DEVIATION 22.89 • n=3087 Participants • Here, number analyzed indicates participants who were evaluated for this baseline characteristic.
|
100.4 kg
STANDARD_DEVIATION 22.68 • n=6185 Participants • Here, number analyzed indicates participants who were evaluated for this baseline characteristic.
|
|
Body Mass Index (BMI)
|
32.5 kg/m^2
n=3098 Participants • Here, number analyzed indicates participants who were evaluated for this baseline characteristic.
|
32.1 kg/m^2
n=3087 Participants • Here, number analyzed indicates participants who were evaluated for this baseline characteristic.
|
32.3 kg/m^2
n=6185 Participants • Here, number analyzed indicates participants who were evaluated for this baseline characteristic.
|
|
BMI Categorical
<25
|
201 Participants
n=3098 Participants
|
201 Participants
n=3092 Participants
|
402 Participants
n=6190 Participants
|
|
BMI Categorical
25-30
|
844 Participants
n=3098 Participants
|
862 Participants
n=3092 Participants
|
1706 Participants
n=6190 Participants
|
|
BMI Categorical
≥30
|
2053 Participants
n=3098 Participants
|
2024 Participants
n=3092 Participants
|
4077 Participants
n=6190 Participants
|
|
Smoking History
Never smoked
|
1175 Participants
n=3098 Participants
|
1124 Participants
n=3092 Participants
|
2299 Participants
n=6190 Participants
|
|
Smoking History
Ex-smoker
|
1533 Participants
n=3098 Participants
|
1553 Participants
n=3092 Participants
|
3086 Participants
n=6190 Participants
|
|
Smoking History
Current smoker
|
390 Participants
n=3098 Participants
|
415 Participants
n=3092 Participants
|
805 Participants
n=6190 Participants
|
|
Alcohol History
Never drank
|
792 Participants
n=3098 Participants
|
784 Participants
n=3092 Participants
|
1576 Participants
n=6190 Participants
|
|
Alcohol History
Ex-drinker
|
805 Participants
n=3098 Participants
|
812 Participants
n=3092 Participants
|
1617 Participants
n=6190 Participants
|
|
Alcohol History
Current drinker
|
1501 Participants
n=3098 Participants
|
1496 Participants
n=3092 Participants
|
2997 Participants
n=6190 Participants
|
|
Renal Function
Moderately Impaired
|
1636 Participants
n=3098 Participants
|
1631 Participants
n=3092 Participants
|
3267 Participants
n=6190 Participants
|
|
Renal Function
Mildly Impaired
|
1217 Participants
n=3098 Participants
|
1231 Participants
n=3092 Participants
|
2448 Participants
n=6190 Participants
|
|
Renal Function
Normal
|
239 Participants
n=3098 Participants
|
228 Participants
n=3092 Participants
|
467 Participants
n=6190 Participants
|
|
History of Kidney Stone
Yes
|
627 Participants
n=3098 Participants
|
627 Participants
n=3092 Participants
|
1254 Participants
n=6190 Participants
|
|
History of Kidney Stone
No
|
2471 Participants
n=3098 Participants
|
2465 Participants
n=3092 Participants
|
4936 Participants
n=6190 Participants
|
|
Use of Low Dose Aspirin
Yes
|
1496 Participants
n=3098 Participants
|
1481 Participants
n=3092 Participants
|
2977 Participants
n=6190 Participants
|
|
Use of Low Dose Aspirin
No
|
1602 Participants
n=3098 Participants
|
1611 Participants
n=3092 Participants
|
3213 Participants
n=6190 Participants
|
|
Use of any Dose of Aspirin
Yes
|
1894 Participants
n=3098 Participants
|
1933 Participants
n=3092 Participants
|
3827 Participants
n=6190 Participants
|
|
Use of any Dose of Aspirin
No
|
1204 Participants
n=3098 Participants
|
1159 Participants
n=3092 Participants
|
2363 Participants
n=6190 Participants
|
|
Use of Nonsteroidal Anti-Inflammatory Drug (NSAIDs)
Yes
|
856 Participants
n=3098 Participants
|
908 Participants
n=3092 Participants
|
1764 Participants
n=6190 Participants
|
|
Use of Nonsteroidal Anti-Inflammatory Drug (NSAIDs)
No
|
2242 Participants
n=3098 Participants
|
2184 Participants
n=3092 Participants
|
4426 Participants
n=6190 Participants
|
|
Use of Clopidogrel and Other Antiplatelet Drugs
Yes
|
599 Participants
n=3098 Participants
|
627 Participants
n=3092 Participants
|
1226 Participants
n=6190 Participants
|
|
Use of Clopidogrel and Other Antiplatelet Drugs
No
|
2499 Participants
n=3098 Participants
|
2465 Participants
n=3092 Participants
|
4964 Participants
n=6190 Participants
|
PRIMARY outcome
Timeframe: Up to last dose of study drug (approximately 83 months)Population: Full Analysis Set (FAS) included all participants who were randomized and received at least 1 dose of double-blind study medication.
Major adverse cardiovascular events (MACE) were defined as a composite of cardiovascular (CV) death, non-fatal myocardial infarction (MI), nonfatal stroke and unstable angina with urgent coronary revascularization; these events were adjudicated by an independent cardiovascular endpoints committee.
Outcome measures
| Measure |
Febuxostat
n=3039 Participants
Febuxostat 40 mg (or 80 mg beginning on week 4 if serum uric acid level was ≥6.0 mg/dL), tablets, orally, once daily for up to approximately 82 months.
|
Allopurinol
n=3034 Participants
Allopurinol 300 mg to 600 mg (increased in 100 mg increments each month until serum uric acid was \<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with mildly impaired renal function or normal renal function (estimated creatinine clearance \[eCLcr\] ≥60 mL/min) or allopurinol 200 mg to 400 mg (increased in 100 mg increments each month until serum uric acid was \<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with moderately impaired renal function (eCLcr ≥30 but \<60 mL/min).
|
|---|---|---|
|
Percentage of Participants With Primary Major Adverse Cardiovascular Events (MACE) Composite (75% Interim Analysis)
|
8.0 percentage of participants
|
8.0 percentage of participants
|
PRIMARY outcome
Timeframe: Up to last dose of study drug (approximately 83 months)Population: FAS included all participants who were randomized and received at least 1 dose of double-blind study medication.
Major adverse cardiovascular events (MACE) were defined as a composite of cardiovascular (CV) death, non-fatal myocardial infarction (MI), nonfatal stroke and unstable angina with urgent coronary revascularization; these events were adjudicated by an independent cardiovascular endpoints committee.
Outcome measures
| Measure |
Febuxostat
n=3098 Participants
Febuxostat 40 mg (or 80 mg beginning on week 4 if serum uric acid level was ≥6.0 mg/dL), tablets, orally, once daily for up to approximately 82 months.
|
Allopurinol
n=3092 Participants
Allopurinol 300 mg to 600 mg (increased in 100 mg increments each month until serum uric acid was \<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with mildly impaired renal function or normal renal function (estimated creatinine clearance \[eCLcr\] ≥60 mL/min) or allopurinol 200 mg to 400 mg (increased in 100 mg increments each month until serum uric acid was \<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with moderately impaired renal function (eCLcr ≥30 but \<60 mL/min).
|
|---|---|---|
|
Percentage of Participants With Primary MACE Composite (Final Analysis)
|
10.8 percentage of participants
|
10.4 percentage of participants
|
SECONDARY outcome
Timeframe: Up to last dose of study drug (approximately 83 months)Population: FAS included all participants who were randomized and received at least 1 dose of double-blind study medication.
APTC events were defined as a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke; these events were adjudicated by an independent cardiovascular endpoints committee.
Outcome measures
| Measure |
Febuxostat
n=3098 Participants
Febuxostat 40 mg (or 80 mg beginning on week 4 if serum uric acid level was ≥6.0 mg/dL), tablets, orally, once daily for up to approximately 82 months.
|
Allopurinol
n=3092 Participants
Allopurinol 300 mg to 600 mg (increased in 100 mg increments each month until serum uric acid was \<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with mildly impaired renal function or normal renal function (estimated creatinine clearance \[eCLcr\] ≥60 mL/min) or allopurinol 200 mg to 400 mg (increased in 100 mg increments each month until serum uric acid was \<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with moderately impaired renal function (eCLcr ≥30 but \<60 mL/min).
|
|---|---|---|
|
Percentage of Participants With Antiplatelet Trialists' Collaborative (APTC) Event
|
9.6 percentage of participants
|
8.8 percentage of participants
|
SECONDARY outcome
Timeframe: Up to last dose of study drug (approximately 83 months)Population: FAS included all participants who were randomized and received at least 1 dose of double-blind study medication.
Events were adjudicated by an independent cardiovascular endpoints committee as CV death.
Outcome measures
| Measure |
Febuxostat
n=3098 Participants
Febuxostat 40 mg (or 80 mg beginning on week 4 if serum uric acid level was ≥6.0 mg/dL), tablets, orally, once daily for up to approximately 82 months.
|
Allopurinol
n=3092 Participants
Allopurinol 300 mg to 600 mg (increased in 100 mg increments each month until serum uric acid was \<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with mildly impaired renal function or normal renal function (estimated creatinine clearance \[eCLcr\] ≥60 mL/min) or allopurinol 200 mg to 400 mg (increased in 100 mg increments each month until serum uric acid was \<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with moderately impaired renal function (eCLcr ≥30 but \<60 mL/min).
|
|---|---|---|
|
Percentage of Participants With Cardiovascular (CV) Death
|
4.3 percentage of participants
|
3.2 percentage of participants
|
SECONDARY outcome
Timeframe: Up to last dose of study drug (approximately 83 months)Population: FAS included all participants who were randomized and received at least 1 dose of double-blind study medication.
Events were adjudicated by an independent cardiovascular endpoints committee as non-fatal MI.
Outcome measures
| Measure |
Febuxostat
n=3098 Participants
Febuxostat 40 mg (or 80 mg beginning on week 4 if serum uric acid level was ≥6.0 mg/dL), tablets, orally, once daily for up to approximately 82 months.
|
Allopurinol
n=3092 Participants
Allopurinol 300 mg to 600 mg (increased in 100 mg increments each month until serum uric acid was \<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with mildly impaired renal function or normal renal function (estimated creatinine clearance \[eCLcr\] ≥60 mL/min) or allopurinol 200 mg to 400 mg (increased in 100 mg increments each month until serum uric acid was \<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with moderately impaired renal function (eCLcr ≥30 but \<60 mL/min).
|
|---|---|---|
|
Percentage of Participants With Non-fatal Myocardial Infarction (MI)
|
3.6 percentage of participants
|
3.8 percentage of participants
|
SECONDARY outcome
Timeframe: Up to last dose of study drug (approximately 83 months)Population: FAS included all participants who were randomized and received at least 1 dose of double-blind study medication.
Events were adjudicated by an independent cardiovascular endpoints committee as non-fatal stroke.
Outcome measures
| Measure |
Febuxostat
n=3098 Participants
Febuxostat 40 mg (or 80 mg beginning on week 4 if serum uric acid level was ≥6.0 mg/dL), tablets, orally, once daily for up to approximately 82 months.
|
Allopurinol
n=3092 Participants
Allopurinol 300 mg to 600 mg (increased in 100 mg increments each month until serum uric acid was \<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with mildly impaired renal function or normal renal function (estimated creatinine clearance \[eCLcr\] ≥60 mL/min) or allopurinol 200 mg to 400 mg (increased in 100 mg increments each month until serum uric acid was \<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with moderately impaired renal function (eCLcr ≥30 but \<60 mL/min).
|
|---|---|---|
|
Percentage of Participants With Non-fatal Stroke
|
2.3 percentage of participants
|
2.3 percentage of participants
|
SECONDARY outcome
Timeframe: Up to last dose of study drug (approximately 83 months)Population: FAS included all participants who were randomized and received at least 1 dose of double-blind study medication.
Events were adjudicated by an independent cardiovascular endpoints committee as unstable angina with urgent coronary revascularization.
Outcome measures
| Measure |
Febuxostat
n=3098 Participants
Febuxostat 40 mg (or 80 mg beginning on week 4 if serum uric acid level was ≥6.0 mg/dL), tablets, orally, once daily for up to approximately 82 months.
|
Allopurinol
n=3092 Participants
Allopurinol 300 mg to 600 mg (increased in 100 mg increments each month until serum uric acid was \<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with mildly impaired renal function or normal renal function (estimated creatinine clearance \[eCLcr\] ≥60 mL/min) or allopurinol 200 mg to 400 mg (increased in 100 mg increments each month until serum uric acid was \<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with moderately impaired renal function (eCLcr ≥30 but \<60 mL/min).
|
|---|---|---|
|
Percentage of Participants With Unstable Angina With Urgent Coronary Revascularization
|
1.6 percentage of participants
|
1.8 percentage of participants
|
Adverse Events
Febuxostat
Serious events: 1046 serious events
Other events: 1450 other events
Deaths: 243 deaths
Allopurinol
Serious events: 995 serious events
Other events: 1467 other events
Deaths: 199 deaths
Serious adverse events
| Measure |
Febuxostat
n=3098 participants at risk
Febuxostat 40 mg (or 80 mg beginning on week 4 if serum uric acid level was ≥6.0 mg/dL), tablets, orally, once daily for up to approximately 82 months.
|
Allopurinol
n=3092 participants at risk
Allopurinol 300 mg to 600 mg (increased in 100 mg increments each month until serum uric acid was \<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with mildly impaired renal function or normal renal function (estimated creatinine clearance \[eCLcr\] ≥60 mL/min) or allopurinol 200 mg to 400 mg (increased in 100 mg increments each month until serum uric acid was \<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with moderately impaired renal function (eCLcr ≥30 but \<60 mL/min).
|
|---|---|---|
|
Nervous system disorders
Presyncope
|
0.32%
10/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Paraesthesia
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Paralysis
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Quadriparesis
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Parkinson's disease
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Seizure
|
0.23%
7/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.36%
11/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Slow speech
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Nerve root compression
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Radiculopathy
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Spinal claudication
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Spinal cord disorder
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Spondylitic myelopathy
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Renal injury
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Brain injury
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Cerebral ventricle dilatation
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.81%
25/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.71%
22/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Product Issues
Device dislocation
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Product Issues
Device failure
|
0.13%
4/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Product Issues
Device lead issue
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Product Issues
Device battery issue
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Product Issues
Device malfunction
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Product Issues
Device occlusion
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Product Issues
Device lead damage
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Anxiety
|
0.10%
3/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Confusional state
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.16%
5/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Disorientation
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Delirium
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Delirium tremens
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Depression
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Mental status changes
|
0.23%
7/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.32%
10/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Shared psychotic disorder
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Substance use disorder
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Intentional self-injury
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Suicidal behaviour
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Suicidal ideation
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Suicide attempt
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.13%
4/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Bladder outlet obstruction
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Renal haematoma
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
4.5%
139/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.3%
132/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.26%
8/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.13%
4/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
End stage renal disease
|
0.16%
5/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.61%
19/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.61%
19/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Renal impairment
|
0.23%
7/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Malignant renal hypertension
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.26%
8/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.10%
3/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.16%
5/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Renal vein thrombosis
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.13%
4/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Polyuria
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Rectocele
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Pelvic haematoma
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.19%
6/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.19%
6/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.71%
22/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.68%
21/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.10%
3/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.16%
5/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.13%
4/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.87%
27/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.1%
35/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.10%
3/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.32%
10/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.10%
3/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal dysplasia
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis allergic
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.16%
5/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.16%
5/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary sarcoidosis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.13%
4/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.13%
4/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.13%
4/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Restrictive pulmonary disease
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.10%
3/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.13%
4/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.42%
13/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.74%
23/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.13%
4/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.13%
4/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.16%
5/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.65%
20/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.45%
14/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.1%
34/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.4%
43/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.10%
3/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.55%
17/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.71%
22/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.16%
5/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.16%
5/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Diabetic ulcer
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.10%
3/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.16%
5/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Surgical and medical procedures
Leg amputation
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Accelerated hypertension
|
0.10%
3/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hypertensive crisis
|
0.32%
10/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hypertensive emergency
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Malignant hypertension
|
0.19%
6/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Aortic aneurysm
|
0.13%
4/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.36%
11/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Aortic occlusion
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Aortic stenosis
|
0.29%
9/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Leriche syndrome
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hypovolaemic shock
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Shock
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Haematoma
|
0.19%
6/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Haemorrhage
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Arterial thrombosis
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Embolism venous
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Thrombosis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Arteriosclerosis
|
0.13%
4/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Peripheral venous disease
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Vascular occlusion
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Arterial rupture
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.52%
16/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.49%
15/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Peripheral embolism
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.32%
10/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.19%
6/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Dry gangrene
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Iliac artery occlusion
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Intermittent claudication
|
0.19%
6/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.19%
6/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.13%
4/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Peripheral ischaemia
|
0.23%
7/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Poor peripheral circulation
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Aortic calcification
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Essential hypertension
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hypertension
|
0.36%
11/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.29%
9/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hypotension
|
0.48%
15/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.39%
12/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Arteriovenous fistula
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Orthostatic hypotension
|
0.16%
5/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.23%
7/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Liver abscess
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.36%
11/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.52%
16/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Angina pectoris
|
2.4%
74/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.9%
59/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia haemorrhagic
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Aortic valve calcification
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Aortic valve disease
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Soft tissue infection
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Proteus infection
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.55%
17/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.49%
15/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.10%
3/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.10%
3/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Aortic valve sclerosis
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.13%
4/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.13%
4/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.16%
5/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Bifascicular block
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Defect conduction intraventricular
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Atrial thrombosis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Intracardiac thrombus
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.10%
3/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Malignant hypertensive heart disease
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Cardiac discomfort
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Palpitations
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Cardiac valve disease
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Heart valve incompetence
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Cardiomyopathy
|
0.13%
4/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.39%
12/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.23%
7/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.13%
4/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.13%
4/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Coronary artery disease
|
1.6%
51/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.9%
58/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.23%
7/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.26%
8/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.23%
7/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Cardiac failure
|
0.26%
8/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.29%
9/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Cardiac failure acute
|
0.26%
8/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.29%
9/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.13%
4/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.16%
5/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
4.0%
124/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
3.5%
109/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Cardiogenic shock
|
0.16%
5/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.16%
5/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Ventricular failure
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.19%
6/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.26%
8/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
2.0%
63/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.2%
68/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Angina unstable
|
1.1%
34/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.1%
33/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Myocardial infarction
|
1.3%
41/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.6%
51/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.26%
8/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.16%
5/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Silent myocardial infarction
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Subendocardial ischaemia
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Left ventricular failure
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.19%
6/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Mitral valve prolapse
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Cardiac aneurysm
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Cardiac hypertrophy
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Systolic dysfunction
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Pericarditis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Cardiac tamponade
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Arrhythmia
|
0.13%
4/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.19%
6/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Bradyarrhythmia
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Bradycardia
|
0.39%
12/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.19%
6/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Chronotropic incompetence
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Tachycardia
|
0.26%
8/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.16%
5/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Cor pulmonale
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Right ventricular failure
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
2.1%
65/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.1%
64/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Atrial flutter
|
0.32%
10/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.39%
12/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Atrial tachycardia
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.26%
8/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.19%
6/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.16%
5/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.13%
4/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Accelerated idioventricular rhythm
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Cardiac arrest
|
0.55%
17/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.36%
11/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.13%
4/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.13%
4/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.19%
6/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Ventricular tachyarrhythmia
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.81%
25/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.81%
25/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Congenital, familial and genetic disorders
Cystic lymphangioma
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.13%
4/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Endocrine disorders
Adrenocortical insufficiency acute
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Endocrine disorders
Goitre
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Endocrine disorders
Thyroid mass
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Blindness unilateral
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Sudden visual loss
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Diplopia
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Vision blurred
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal hernia obstructive
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Alcoholic pancreatitis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.23%
7/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.13%
4/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Proctalgia
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Duodenal polyp
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.10%
3/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Pancreatic cyst
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Poor dental condition
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.16%
5/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.10%
3/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.13%
4/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diverticulum
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.29%
9/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.16%
5/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Volvulus of small bowel
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.10%
3/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Haemorrhagic erosive gastritis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.10%
3/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.26%
8/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.36%
11/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.19%
6/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Food poisoning
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Oesophageal achalasia
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Duodenitis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Enteritis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.13%
4/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.13%
4/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Oesophageal food impaction
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Ileus
|
0.13%
4/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Intussusception
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Colonic haematoma
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Mesenteric haemorrhage
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.13%
4/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Rectal adenocarcinoma
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Bacteraemia
|
0.19%
6/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.13%
4/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.13%
4/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting projectile
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.58%
18/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.55%
17/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.13%
4/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.16%
5/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Oesophageal ulcer haemorrhage
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.13%
4/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Asthenia
|
0.13%
4/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.26%
8/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Fatigue
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Medical device pain
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Accidental death
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Death
|
0.16%
5/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Drowning
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Sudden cardiac death
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Sudden death
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Pyrexia
|
0.10%
3/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Condition aggravated
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
General physical health deterioration
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Local swelling
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Impaired healing
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Strangulated hernia
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Implant site inflammation
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.10%
3/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Haemorrhagic cyst
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Necrobiosis
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Generalised oedema
|
0.10%
3/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Oedema
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Oedema peripheral
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Chest discomfort
|
0.13%
4/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.26%
8/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Chest pain
|
0.81%
25/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.81%
25/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Non-cardiac chest pain
|
1.1%
34/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.0%
32/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Pain
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Surgical failure
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Ulcer haemorrhage
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Vascular stent occlusion
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Vascular stent restenosis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Biliary colic
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Cholangitis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.19%
6/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.23%
7/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.23%
7/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.26%
8/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.16%
5/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.29%
9/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Jaundice
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.13%
4/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Hepatic haematoma
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Granulomatous liver disease
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Hepatitis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Liver injury
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Immune system disorders
Sarcoidosis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Immune system disorders
Drug hypersensitivity
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Immune system disorders
Anaphylactic reaction
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Abdominal wall abscess
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Appendicitis
|
0.10%
3/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Colonic abscess
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Diverticulitis
|
0.23%
7/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.29%
9/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.23%
7/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.23%
7/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Bacterial infection
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Bacterial sepsis
|
0.10%
3/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Bronchitis bacterial
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Cellulitis
|
0.97%
30/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.68%
21/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Cellulitis of male external genital organ
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Endocarditis bacterial
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Gangrene
|
0.13%
4/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Incisional hernia gangrenous
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Meningitis bacterial
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Oral bacterial infection
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pneumonia bacterial
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Bursitis infective
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Intervertebral discitis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Osteomyelitis
|
0.48%
15/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.29%
9/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Osteomyelitis acute
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pertussis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Lyme disease
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Endocarditis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
CNS ventriculitis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Meningitis
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.10%
3/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Clostridium difficile infection
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Gas gangrene
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Tooth abscess
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Labyrinthitis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Escherichia sepsis
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Vulval abscess
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Hepatitis C
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Cholecystitis infective
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Herpes simplex meningitis
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Herpes zoster
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Herpes zoster meningomyelitis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Varicella zoster virus infection
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Abscess
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Abscess limb
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Abscess rupture
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Device related infection
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Empyema
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Groin abscess
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Groin infection
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Implant site infection
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Incision site infection
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Infected bite
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Infection
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Injection site infection
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Localised infection
|
0.10%
3/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Mediastinitis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Medical device site infection
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Postoperative abscess
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Postoperative wound infection
|
0.10%
3/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Wound infection
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Influenza
|
0.29%
9/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pneumonia legionella
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Bronchitis
|
0.32%
10/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.29%
9/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Infectious pleural effusion
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pneumonia
|
2.2%
67/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
2.8%
88/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pneumonia necrotising
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Necrotising fasciitis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Sepsis
|
0.77%
24/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.78%
24/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Septic embolus
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Septic shock
|
0.23%
7/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.32%
10/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Urosepsis
|
0.29%
9/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.13%
4/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Carbuncle
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Diabetic foot infection
|
0.13%
4/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Infected skin ulcer
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Skin infection
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Endocarditis staphylococcal
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Staphylococcal abscess
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Staphylococcal infection
|
0.23%
7/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Staphylococcal parotitis
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Beta haemolytic streptococcal infection
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Cellulitis streptococcal
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Streptococcal sepsis
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Cellulitis pharyngeal
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pharyngitis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Tracheitis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Tracheobronchitis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Cystitis
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Kidney infection
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.13%
4/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pyelonephritis acute
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.45%
14/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.68%
21/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Lymphangitis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Encephalitis viral
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Gastroenteritis viral
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pneumonia viral
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Viral infection
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Post procedural myocardial infarction
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Vascular injury
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Epidural haemorrhage
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.13%
4/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.13%
4/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.19%
6/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Exposure to toxic agent
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Open globe injury
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Open fracture
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Intestinal anastomosis complication
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.19%
6/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.19%
6/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Psychosis postoperative
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.23%
7/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.42%
13/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Post concussion syndrome
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.16%
5/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.16%
5/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Failure to anastomose
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Incisional hernia, obstructive
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Procedural hypertension
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.13%
4/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Postoperative respiratory distress
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Postoperative thoracic procedure complication
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Tracheostomy malfunction
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.16%
5/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Scrotal haematoma
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.10%
3/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.13%
4/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood glucose decreased
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood glucose increased
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Ejection fraction decreased
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
International normalised ratio increased
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Prothrombin time ratio decreased
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Occult blood positive
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Heart rate increased
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Heart rate irregular
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Computerised tomogram abnormal
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Laboratory test abnormal
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood bilirubin increased
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Hepatic enzyme increased
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Liver function test increased
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Transaminases increased
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Body temperature increased
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Weight decreased
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Haemoglobin decreased
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood creatine increased
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood creatinine increased
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Troponin increased
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Cardioactive drug level increased
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood pressure increased
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Influenza B virus test positive
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
White blood cell count increased
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.16%
5/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Diabetic complication
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Gout
|
0.13%
4/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.19%
6/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hyperosmolar state
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Obesity
|
0.10%
3/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.26%
8/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.13%
4/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.39%
12/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.32%
10/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.29%
9/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.32%
10/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.13%
4/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.71%
22/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.74%
23/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.39%
12/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.23%
7/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neuropathic arthropathy
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.10%
3/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.13%
4/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.16%
5/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.26%
8/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.13%
4/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.32%
10/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.23%
7/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.26%
8/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.16%
5/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.13%
4/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.16%
5/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.3%
40/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.1%
34/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Vertebral osteophyte
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.16%
5/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.19%
6/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.19%
6/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.19%
6/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal squamous cell carcinoma
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma stage II
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.26%
8/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma recurrent
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular breast carcinoma
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.13%
4/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.29%
9/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.13%
4/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleomorphic malignant fibrous histiocytoma
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine benign neoplasm
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal cancer metastatic
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal squamous cell carcinoma
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign salivary gland neoplasm
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the oral cavity
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign anorectal neoplasm
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to pleura
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myelomonocytic leukaemia
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelofibrosis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Polycythaemia vera
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenosquamous cell carcinoma
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Head and neck cancer
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage IV
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage I
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of eyelid
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour ulceration
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ductal adenocarcinoma of pancreas
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.10%
3/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.13%
4/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of pharynx
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage III
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kidney angiomyolipoma
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.10%
3/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.13%
4/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.16%
5/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.13%
4/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.13%
4/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma stage II
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma of the skin
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Poorly differentiated thyroid carcinoma
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of bladder
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Petit mal epilepsy
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Brain stem infarction
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Brain stem stroke
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Cerebellar infarction
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Cerebral haematoma
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Cerebral infarction
|
0.19%
6/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.5%
45/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.4%
44/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Embolic stroke
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.19%
6/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Ischaemic stroke
|
0.10%
3/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Lacunar infarction
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Lacunar stroke
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Thalamic infarction
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Thalamus haemorrhage
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Thrombotic stroke
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Carotid artery disease
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.23%
7/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.32%
10/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Cervical myelopathy
|
0.06%
2/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Coma
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Diabetic coma
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Aphasia
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dementia
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Syncope
|
0.97%
30/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
1.1%
34/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Loss of consciousness
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Encephalitis autoimmune
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Encephalopathy
|
0.16%
5/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.16%
5/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.10%
3/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Hypoglycaemic encephalopathy
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.19%
6/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Uraemic encephalopathy
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Facial paralysis
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Cluster headache
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.10%
3/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Hydrocephalus
|
0.10%
3/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.06%
2/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.03%
1/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.03%
1/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
0.19%
6/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.13%
4/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Febuxostat
n=3098 participants at risk
Febuxostat 40 mg (or 80 mg beginning on week 4 if serum uric acid level was ≥6.0 mg/dL), tablets, orally, once daily for up to approximately 82 months.
|
Allopurinol
n=3092 participants at risk
Allopurinol 300 mg to 600 mg (increased in 100 mg increments each month until serum uric acid was \<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with mildly impaired renal function or normal renal function (estimated creatinine clearance \[eCLcr\] ≥60 mL/min) or allopurinol 200 mg to 400 mg (increased in 100 mg increments each month until serum uric acid was \<6.0 mg/dL), tablets, orally, once daily for up to approximately 83 months to participants with moderately impaired renal function (eCLcr ≥30 but \<60 mL/min).
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
5.1%
157/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.0%
125/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.7%
299/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
9.2%
284/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
5.0%
156/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
4.3%
132/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Oedema peripheral
|
5.4%
168/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
183/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Bronchitis
|
6.9%
214/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.9%
212/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.8%
242/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.6%
267/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Urinary tract infection
|
4.7%
146/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.8%
180/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
4.8%
148/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.2%
161/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
258/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.1%
311/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.0%
216/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
6.0%
187/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
4.4%
137/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.1%
159/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.2%
222/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
7.1%
218/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hypertension
|
6.7%
209/3098 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
8.4%
261/3092 • First dose of study drug to 30 days after last dose of study drug (Approximately 84 months)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER