Trial Outcomes & Findings for CSP594 Comparative Effectiveness in Gout: Allopurinol vs. Febuxostat (NCT NCT02579096)
NCT ID: NCT02579096
Last Updated: 2024-03-29
Results Overview
Participants were defined as flaring in Phase 3 if they: -1) met 3 of 4 following participant-reported criteria: * a) warm joint(s) * b) swollen joint(s) * c) pain (\>3) at rest on a scale of 0-10 (10 being the worst pain) * d) self-identified gout flare OR -2) reported use of medications to treat flare
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
950 participants
Primary outcome timeframe
Phase III of the study (weeks 49-72 of study duration)
Results posted on
2024-03-29
Participant Flow
Total of 950 subjects were enrolled into the study. However, 10 subjects were excluded from study participation : * 3 due to screening errors * 7 dropped out before receiving study treatment
Participant milestones
| Measure |
Allopurinol / Sham Comparator (Febuxostat)
Patients will be up-titrated up to the dose required to reach target uric acid levels.
Allopurinol: allopurinol capsule, 100-800 mg by mouth once daily
Placebo: tablets resembling febuxostat will be given with allopurinol.
|
Febuxostat / Sham Comparator (Allopurinol)
Patients will be up-titrated to the dose required to reach target uric acid levels.
Febuxostat: tablet 40-120 mg by mouth once daily
Placebo: capsules resembling allopurinol will be given with febuxostat.
|
|---|---|---|
|
Phase 1, Weeks 0 - 24
STARTED
|
468
|
472
|
|
Phase 1, Weeks 0 - 24
COMPLETED
|
411
|
422
|
|
Phase 1, Weeks 0 - 24
NOT COMPLETED
|
57
|
50
|
|
Phase 2, Weeks 25 - 48
STARTED
|
411
|
422
|
|
Phase 2, Weeks 25 - 48
COMPLETED
|
389
|
391
|
|
Phase 2, Weeks 25 - 48
NOT COMPLETED
|
22
|
31
|
|
Phase 3, Weeks 49 - 72
STARTED
|
389
|
391
|
|
Phase 3, Weeks 49 - 72
COMPLETED
|
367
|
373
|
|
Phase 3, Weeks 49 - 72
NOT COMPLETED
|
22
|
18
|
Reasons for withdrawal
| Measure |
Allopurinol / Sham Comparator (Febuxostat)
Patients will be up-titrated up to the dose required to reach target uric acid levels.
Allopurinol: allopurinol capsule, 100-800 mg by mouth once daily
Placebo: tablets resembling febuxostat will be given with allopurinol.
|
Febuxostat / Sham Comparator (Allopurinol)
Patients will be up-titrated to the dose required to reach target uric acid levels.
Febuxostat: tablet 40-120 mg by mouth once daily
Placebo: capsules resembling allopurinol will be given with febuxostat.
|
|---|---|---|
|
Phase 1, Weeks 0 - 24
Side effects with study medications
|
10
|
6
|
|
Phase 1, Weeks 0 - 24
Physician Decision
|
2
|
1
|
|
Phase 1, Weeks 0 - 24
Withdrawal by Subject
|
32
|
36
|
|
Phase 1, Weeks 0 - 24
Lost to Follow-up
|
9
|
4
|
|
Phase 1, Weeks 0 - 24
Other reasons
|
4
|
3
|
|
Phase 2, Weeks 25 - 48
Death
|
2
|
4
|
|
Phase 2, Weeks 25 - 48
Side effects with study medications
|
3
|
1
|
|
Phase 2, Weeks 25 - 48
Physician Decision
|
4
|
0
|
|
Phase 2, Weeks 25 - 48
Withdrawal by Subject
|
9
|
12
|
|
Phase 2, Weeks 25 - 48
Lost to Follow-up
|
4
|
9
|
|
Phase 2, Weeks 25 - 48
Other reasons
|
0
|
5
|
|
Phase 3, Weeks 49 - 72
Death
|
3
|
2
|
|
Phase 3, Weeks 49 - 72
Side effects with study medications
|
0
|
1
|
|
Phase 3, Weeks 49 - 72
Physician Decision
|
0
|
5
|
|
Phase 3, Weeks 49 - 72
Withdrawal by Subject
|
6
|
4
|
|
Phase 3, Weeks 49 - 72
Lost to Follow-up
|
10
|
5
|
|
Phase 3, Weeks 49 - 72
Participant required to take exclusion medication on a regular basis
|
0
|
1
|
|
Phase 3, Weeks 49 - 72
Other reasons
|
3
|
0
|
Baseline Characteristics
CSP594 Comparative Effectiveness in Gout: Allopurinol vs. Febuxostat
Baseline characteristics by cohort
| Measure |
Allopurinol / Sham Comparator (Febuxostat)
n=468 Participants
Patients will be titrated up to the dose that will lower to target uric acid levels. A placebo resembling febuxostat will be given with allopurinol
allopurinol: Patients will be titrated up to the dose that will lower to target uric acid levels.
Placebo, vehicle control (febuxostat-shaped): Placebo in the shape of febuxostat will be given with allopurinol
|
Febuxostat / Sham Comparator (Allopurinol)
n=472 Participants
febuxostat will be titrated up to the dose that will lower to target uric acid levels. A placebo resembling Allopurinol will be given with febuxostat
febuxostat: febuxostat will be titrated up to the dose that will lower to target uric acid levels.
Placebo, vehicle control (allopurinol-shaped): Placebo in the shape of allopurinol will be given with febuxostat
|
Total
n=940 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.9 years
STANDARD_DEVIATION 11.8 • n=39 Participants
|
61.3 years
STANDARD_DEVIATION 12.9 • n=41 Participants
|
62.1 years
STANDARD_DEVIATION 12.4 • n=35 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
15 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
461 Participants
n=39 Participants
|
464 Participants
n=41 Participants
|
925 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=39 Participants
|
27 Participants
n=41 Participants
|
47 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
444 Participants
n=39 Participants
|
443 Participants
n=41 Participants
|
887 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
29 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
10 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
19 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
104 Participants
n=39 Participants
|
102 Participants
n=41 Participants
|
206 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
315 Participants
n=39 Participants
|
322 Participants
n=41 Participants
|
637 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
27 Participants
n=35 Participants
|
|
CKD3
|
181 Participants
n=39 Participants
|
170 Participants
n=41 Participants
|
351 Participants
n=35 Participants
|
|
Tophus
|
81 Participants
n=39 Participants
|
71 Participants
n=41 Participants
|
152 Participants
n=35 Participants
|
|
sUA >= 9 mg/dL
|
160 Participants
n=39 Participants
|
148 Participants
n=41 Participants
|
308 Participants
n=35 Participants
|
|
Pre-study allopurinol users with dose <= 300 mg
|
178 Participants
n=39 Participants
|
167 Participants
n=41 Participants
|
345 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Phase III of the study (weeks 49-72 of study duration)Population: Primary analysis excluded patients who either never received the trial interventions, or were identified as ineligible after randomization, or dropouts; a complete case analysis was conducted on total of 749 subjects: 740 who completed phase 3 of the study plus 9 subjects who terminated in phase 3 after having an outcome.
Participants were defined as flaring in Phase 3 if they: -1) met 3 of 4 following participant-reported criteria: * a) warm joint(s) * b) swollen joint(s) * c) pain (\>3) at rest on a scale of 0-10 (10 being the worst pain) * d) self-identified gout flare OR -2) reported use of medications to treat flare
Outcome measures
| Measure |
Allopurinol / Sham Comparator (Febuxostat)
n=370 Participants
Patients will be titrated up to the dose that will lower to target uric acid levels. A placebo resembling Febuxostat will be given with allopurinol
Allopurinol: Patients will be titrated up to the dose that will lower to target uric acid levels.
Placebo, vehicle control (Febuxostat-shaped): Placebo in the shape of Febuxostat will be given with Allopurinol
|
Febuxostat / Sham Comparator (Allopurinol)
n=379 Participants
Febuxostat will be titrated up to the dose that will lower to target uric acid levels. A placebo resembling Allopurinol will be given with Febuxostat
Febuxostat: Febuxostat will be titrated up to the dose that will lower to target uric acid levels.
Placebo, vehicle control (Allopurinol-shaped): Placebo in the shape of Allopurinol will be given with Febuxostat
|
|---|---|---|
|
Percentage of Participants Experiencing ≥ 1 Gout Flare During Phase 3
|
135 Participants
|
165 Participants
|
Adverse Events
Allopurinol / Sham Comparator (Febuxostat)
Serious events: 125 serious events
Other events: 36 other events
Deaths: 8 deaths
Febuxostat / Sham Comparator (Allopurinol)
Serious events: 123 serious events
Other events: 44 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Allopurinol / Sham Comparator (Febuxostat)
n=468 participants at risk
Patients will be titrated up to the dose that will lower to target uric acid levels. A placebo resembling Febuxostat will be given with allopurinol
Allopurinol: Patients will be titrated up to the dose that will lower to target uric acid levels.
Placebo, vehicle control (Febuxostat-shaped): Placebo in the shape of Febuxostat will be given with Allopurinol
|
Febuxostat / Sham Comparator (Allopurinol)
n=472 participants at risk
Febuxostat will be titrated up to the dose that will lower to target uric acid levels. A placebo resembling Allopurinol will be given with Febuxostat
Febuxostat: Febuxostat will be titrated up to the dose that will lower to target uric acid levels.
Placebo, vehicle control (Allopurinol-shaped): Placebo in the shape of Allopurinol will be given with Febuxostat
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.43%
2/468 • Number of events 5 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.64%
3/472 • Number of events 5 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Blood and lymphatic system disorders
Spontaneous haematoma
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Cardiac disorders
Angina unstable
|
0.85%
4/468 • Number of events 4 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.64%
3/472 • Number of events 4 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
2.6%
12/468 • Number of events 18 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
1.7%
8/472 • Number of events 11 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Cardiac disorders
Bradycardia
|
0.64%
3/468 • Number of events 3 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Cardiac disorders
Cardiac failure
|
5.8%
27/468 • Number of events 56 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
2.5%
12/472 • Number of events 19 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Cardiac disorders
Coronary artery disease
|
0.64%
3/468 • Number of events 3 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.42%
2/472 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Cardiac disorders
Hypertensive cardiomyopathy
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Cardiac disorders
Mitral valve disease
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Cardiac disorders
Myocardial infarction
|
0.85%
4/468 • Number of events 4 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
1.7%
8/472 • Number of events 8 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.43%
2/468 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Cardiac disorders
Tachycardia
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.42%
2/472 • Number of events 3 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.42%
2/472 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Endocrine disorders
Hypothyroidism
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.43%
2/468 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.42%
2/472 • Number of events 3 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Gastrointestinal disorders
Ascites
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.64%
3/468 • Number of events 3 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.42%
2/472 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Gastrointestinal disorders
Glossitis
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Gastrointestinal disorders
Haematemesis
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Gastrointestinal disorders
Ileus
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Gastrointestinal disorders
Melaena
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.43%
2/468 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
General disorders
Adverse drug reaction
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
General disorders
Asthenia
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
General disorders
Cardiac death
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
General disorders
Chest pain
|
1.1%
5/468 • Number of events 5 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.85%
4/472 • Number of events 4 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.1%
5/468 • Number of events 5 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.42%
2/472 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Hepatobiliary disorders
Liver injury
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Immune system disorders
Anaphylactic reaction
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Infections and infestations
Acute haemorrhagic conjunctivitis
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Infections and infestations
Anal abscess
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Infections and infestations
Appendicitis
|
0.43%
2/468 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Infections and infestations
Arthritis bacterial
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Infections and infestations
Bacteraemia
|
0.43%
2/468 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Infections and infestations
Bronchitis
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.42%
2/472 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Infections and infestations
Bursitis infective
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Infections and infestations
COVID-19
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.42%
2/472 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Infections and infestations
Cellulitis
|
1.3%
6/468 • Number of events 6 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
2.5%
12/472 • Number of events 15 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Infections and infestations
Diabetic foot infection
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.64%
3/472 • Number of events 3 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Infections and infestations
Gangrene
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Infections and infestations
Gastroenteritis
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.42%
2/472 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Infections and infestations
Groin abscess
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Infections and infestations
Infection
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Infections and infestations
Influenza
|
0.43%
2/468 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.42%
2/472 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Infections and infestations
Liver abscess
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Infections and infestations
Localised infection
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Infections and infestations
Osteomyelitis
|
0.43%
2/468 • Number of events 4 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.64%
3/472 • Number of events 3 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Infections and infestations
Pneumonia
|
2.1%
10/468 • Number of events 11 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
1.9%
9/472 • Number of events 10 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Infections and infestations
Postoperative wound infection
|
0.64%
3/468 • Number of events 3 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Lung hernia
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Infections and infestations
Sepsis
|
0.43%
2/468 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
1.3%
6/472 • Number of events 8 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.21%
1/468 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.64%
3/472 • Number of events 3 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
1.5%
7/472 • Number of events 8 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Injury, poisoning and procedural complications
Fall
|
1.3%
6/468 • Number of events 6 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.64%
3/472 • Number of events 3 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.43%
2/468 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Injury, poisoning and procedural complications
Wound necrosis
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Investigations
International normalised ratio increased
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.64%
3/472 • Number of events 3 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.64%
3/468 • Number of events 3 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Metabolism and nutrition disorders
Gout
|
0.64%
3/468 • Number of events 3 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.42%
2/472 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.43%
2/468 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
1.1%
5/472 • Number of events 5 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.43%
2/468 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.85%
4/472 • Number of events 4 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.85%
4/472 • Number of events 4 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Metabolism and nutrition disorders
Obesity
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Myopathy toxic
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.43%
2/468 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Vertebral column mass
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Astrocytoma
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.21%
1/468 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelofibrosis
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.43%
2/468 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.64%
3/472 • Number of events 3 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tracheal cancer
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.43%
2/468 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.42%
2/472 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.43%
2/468 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
1.5%
7/472 • Number of events 7 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Nervous system disorders
Dementia
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.64%
3/472 • Number of events 3 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Nervous system disorders
Headache
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Nervous system disorders
IIIrd nerve paresis
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Nervous system disorders
Migraine
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Nervous system disorders
Radiculopathy
|
0.43%
2/468 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Nervous system disorders
Syncope
|
0.43%
2/468 • Number of events 3 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.42%
2/472 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Psychiatric disorders
Alcoholism
|
0.43%
2/468 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.42%
2/472 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Psychiatric disorders
Delirium
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Psychiatric disorders
Depression
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Psychiatric disorders
Substance abuse
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Psychiatric disorders
Substance use disorder
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Psychiatric disorders
Suicidal ideation
|
0.43%
2/468 • Number of events 5 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Psychiatric disorders
Suicide attempt
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Renal and urinary disorders
Acute kidney injury
|
4.1%
19/468 • Number of events 24 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
2.5%
12/472 • Number of events 12 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Renal and urinary disorders
Renal failure
|
0.43%
2/468 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Renal and urinary disorders
Renal mass
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 3 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.5%
7/468 • Number of events 10 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.85%
4/472 • Number of events 6 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.43%
2/468 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.1%
5/468 • Number of events 5 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.85%
4/472 • Number of events 5 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.43%
2/468 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Surgical and medical procedures
Alcohol detoxification
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Surgical and medical procedures
Aneurysm repair
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Surgical and medical procedures
Cardiac ablation
|
0.43%
2/468 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Surgical and medical procedures
Haemorrhoid operation
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.43%
2/468 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.42%
2/472 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.43%
2/468 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.85%
4/472 • Number of events 4 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Surgical and medical procedures
Lung lobectomy
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Surgical and medical procedures
Metabolic surgery
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Surgical and medical procedures
Nephrectomy
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Surgical and medical procedures
Pancreaticosplenectomy
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Surgical and medical procedures
Peripheral artery bypass
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Surgical and medical procedures
Prostatic operation
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Surgical and medical procedures
Shoulder arthroplasty
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Surgical and medical procedures
Skin operation
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Surgical and medical procedures
Spinal fusion surgery
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Surgical and medical procedures
Spinal laminectomy
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Surgical and medical procedures
Spinal operation
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.42%
2/472 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Surgical and medical procedures
Surgery
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Surgical and medical procedures
Tenoplasty
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Surgical and medical procedures
Thyroidectomy
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Surgical and medical procedures
Transurethral prostatectomy
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Vascular disorders
Aortic aneurysm
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Vascular disorders
Deep vein thrombosis
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Vascular disorders
Dry gangrene
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Vascular disorders
Haematoma
|
0.00%
0/468 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.21%
1/472 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Vascular disorders
Hypertension
|
1.1%
5/468 • Number of events 5 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Vascular disorders
Hypotension
|
0.43%
2/468 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.42%
2/472 • Number of events 2 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Vascular disorders
Orthostatic hypotension
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Vascular disorders
Peripheral ischaemia
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
0.00%
0/472 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
Other adverse events
| Measure |
Allopurinol / Sham Comparator (Febuxostat)
n=468 participants at risk
Patients will be titrated up to the dose that will lower to target uric acid levels. A placebo resembling Febuxostat will be given with allopurinol
Allopurinol: Patients will be titrated up to the dose that will lower to target uric acid levels.
Placebo, vehicle control (Febuxostat-shaped): Placebo in the shape of Febuxostat will be given with Allopurinol
|
Febuxostat / Sham Comparator (Allopurinol)
n=472 participants at risk
Febuxostat will be titrated up to the dose that will lower to target uric acid levels. A placebo resembling Allopurinol will be given with Febuxostat
Febuxostat: Febuxostat will be titrated up to the dose that will lower to target uric acid levels.
Placebo, vehicle control (Allopurinol-shaped): Placebo in the shape of Allopurinol will be given with Febuxostat
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.21%
1/468 • Number of events 1 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
1.1%
5/472 • Number of events 5 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.85%
4/468 • Number of events 4 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
1.7%
8/472 • Number of events 9 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Gastrointestinal disorders
Nausea
|
0.64%
3/468 • Number of events 3 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
1.3%
6/472 • Number of events 7 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Investigations
Alanine aminotransferase increased
|
3.8%
18/468 • Number of events 18 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
4.4%
21/472 • Number of events 22 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
2.4%
11/468 • Number of events 11 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
2.3%
11/472 • Number of events 11 • Beginning at informed consent and continuing until the end of participation in the study at 72 weeks, plus 30 days of observation.
Data on adverse events was collected spontaneously through patient reports, actively elicited during visits through open-ended questioning and examination, and gathered at the time of telephone contact and medical record reviews during the follow-up period.
|
Additional Information
Ryan E. Ferguson, ScD, MPH, Director
Boston CSP Coordinating Center
Phone: 1-857-364-4201
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place